Regulation on the Supervision and Administration of Medical Devices (2024 Revision).

Promulgated by: State Council.
Promulgated by Order No. 276 of the State Council of the People’s Republic of China on January 4, 2000.
Revised and adopted at the 39th Executive Meeting of the State Council on February 12, 2014.
First amended in accordance with the Decision of the State Council on Amending the Regulation on the Supervision and Administration of Medical Devices on May 4, 2017.
Revised and adopted at the 119th Executive Meeting of the State Council on December 21, 2020.
Second amended in accordance with the Decision of the State Council on Amending and Repealing Certain Administrative Regulations on December 6, 2024.
Current version effective January 20, 2025.

Chapter 1 General Provisions

Article 1. This Regulation is formulated in order to ensure the safety and effectiveness of medical devices, safeguard human health and life safety, and promote the development of the medical device industry.

Article 2. This Regulation shall apply to the research, manufacture, distribution and use of medical devices, as well as the supervision and administration thereof, within the territory of the People’s Republic of China.

Article 3. The drug regulatory department of the State Council shall be responsible for the supervision and administration of medical devices nationwide.

The relevant departments of the State Council shall, within their respective scopes of responsibility, be responsible for the supervision and administration related to medical devices.

Article 4. Local people’s governments at or above the county level shall strengthen leadership over the supervision and administration of medical devices within their administrative regions, organize and coordinate the supervision and administration of medical devices and the response to emergencies within their administrative regions, strengthen capacity building for the supervision and administration of medical devices, and provide safeguards for the work of medical device safety.

The departments responsible for drug regulation under the local people’s governments at or above the county level shall be responsible for the supervision and administration of medical devices within their administrative regions. The relevant departments of the local people’s governments at or above the county level shall, within their respective scopes of responsibility, be responsible for the supervision and administration related to medical devices.

Article 5. The supervision and administration of medical devices shall follow the principles of risk management, full-process control, scientific regulation, and joint social governance.

Article 6. The State shall implement classified management of medical devices according to their degree of risk.

Class I comprises medical devices with a low degree of risk, whose safety and effectiveness can be ensured through routine management.

Class II comprises medical devices with a moderate degree of risk, which require strict control and management to ensure their safety and effectiveness.

Class III comprises medical devices with a relatively high degree of risk, which require special measures of strict control and management to ensure their safety and effectiveness.

In evaluating the degree of risk of a medical device, factors such as the intended purpose, structural features, and method of use of the medical device shall be considered.

The drug regulatory department of the State Council shall be responsible for formulating the classification rules and classification catalogue of medical devices, and shall, in light of the situation of the manufacture, distribution and use of medical devices, promptly analyze and evaluate changes in the risk of medical devices and adjust the classification rules and classification catalogue. In formulating and adjusting the classification rules and classification catalogue, it shall fully solicit the opinions of medical device registrants, filing persons, manufacturing and distribution enterprises, as well as use entities and industry organizations, and shall refer to international practices in the classification of medical devices. The classification rules and classification catalogue of medical devices shall be made public.

Article 7. Medical device products shall comply with the mandatory national standards for medical devices; where there is no mandatory national standard, they shall comply with the mandatory industry standards for medical devices.

Article 8. The State shall formulate plans and policies for the medical device industry, incorporate medical device innovation into development priorities, give priority to the review and approval of innovative medical devices, support the clinical promotion and use of innovative medical devices, and promote the high-quality development of the medical device industry. The drug regulatory department of the State Council shall cooperate with the relevant departments of the State Council in implementing the State’s plans for the medical device industry and its guiding policies.

Article 9. The State shall improve the medical device innovation system, support basic research and applied research on medical devices, promote the popularization and application of new medical device technologies, and provide support in such respects as the establishment of science and technology projects, financing, credit, bidding and procurement, and medical insurance. The State shall support enterprises in establishing or jointly forming research institutions, encourage enterprises to cooperate with institutions of higher learning, scientific research institutes, medical institutions and others in carrying out research and innovation of medical devices, strengthen the protection of intellectual property rights in medical devices, and enhance the capacity for independent innovation of medical devices.

Article 10. The State shall strengthen the informatization of the supervision and administration of medical devices, improve the level of online government services, and provide convenience for administrative licensing, filing and the like of medical devices.

Article 11. Medical device industry organizations shall strengthen industry self-discipline, advance the building of a credit system, urge enterprises to carry out manufacturing and distribution activities in accordance with the law, and guide enterprises to be honest and trustworthy.

Article 12. Entities and individuals that have made outstanding contributions to the research and innovation of medical devices shall be commended and rewarded in accordance with relevant State provisions.

Chapter 2 Registration and Filing of Medical Device Products

Article 13. Class I medical devices shall be subject to product filing administration, and Class II and Class III medical devices shall be subject to product registration administration.

Medical device registrants and filing persons shall strengthen full-lifecycle quality management of medical devices, and shall bear liability in accordance with the law for the safety and effectiveness of medical devices throughout the entire process of research, manufacture, distribution and use.

Article 14. For the filing of Class I medical device products and the application for registration of Class II and Class III medical device products, the following materials shall be submitted:

(I) product risk analysis materials;

(II) product technical requirements;

(III) product inspection reports;

(IV) clinical evaluation materials;

(V) product instructions for use and sample labels;

(VI) quality management system documents related to the research and manufacture of the product;

(VII) other materials necessary to prove the safety and effectiveness of the product.

The product inspection report shall comply with the requirements of the drug regulatory department of the State Council, and may be a self-inspection report of the medical device registration applicant or filing person, or an inspection report issued by a qualified medical device inspection institution as entrusted.

Where the circumstances of exemption from clinical evaluation prescribed in Article 24 of this Regulation are met, clinical evaluation materials may be exempted from submission.

The medical device registration applicant or filing person shall ensure that the materials submitted are lawful, authentic, accurate, complete and traceable.

Article 15. For the filing of Class I medical device products, the filing person shall submit the filing materials to the department responsible for drug regulation under the people’s government of the city divided into districts where it is located.

An overseas filing person that exports Class I medical devices to China shall, through an enterprise legal person within China designated by it, submit the filing materials to the drug regulatory department of the State Council, together with documents certifying that the competent authority of the country (or region) where the filing person is located permits the medical device to be marketed and sold. For innovative medical devices that have not been marketed overseas, the document certifying that the competent authority of the country (or region) where the filing person is located permits the medical device to be marketed and sold need not be submitted.

The filing is completed once the filing person submits to the department responsible for drug regulation the filing materials that comply with the provisions of this Regulation. The department responsible for drug regulation shall, within 5 working days from the date of receipt of the filing materials, make the relevant filing information public through the online government service platform of the drug regulatory department of the State Council.

Where any matter set forth in the filing materials changes, an alteration of the filing shall be made to the original filing department.

Article 16. To apply for registration of a Class II medical device product, the registration applicant shall submit the registration application materials to the drug regulatory department of the people’s government of the province, autonomous region or municipality directly under the Central Government where it is located. To apply for registration of a Class III medical device product, the registration applicant shall submit the registration application materials to the drug regulatory department of the State Council.

An overseas registration applicant that exports Class II or Class III medical devices to China shall, through an enterprise legal person within China designated by it, submit the registration application materials to the drug regulatory department of the State Council, together with documents certifying that the competent authority of the country (or region) where the registration applicant is located permits the medical device to be marketed and sold. For innovative medical devices that have not been marketed overseas, the document certifying that the competent authority of the country (or region) where the registration applicant is located permits the medical device to be marketed and sold need not be submitted.

The drug regulatory department of the State Council shall make provisions on the procedures and requirements for the registration review of medical devices, and shall strengthen supervision and guidance over the registration review work of the drug regulatory departments of the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government.

Article 17. The drug regulatory department that accepts a registration application shall review the safety and effectiveness of the medical device, as well as the quality management capacity of the registration applicant to ensure the safety and effectiveness of the medical device.

The drug regulatory department that accepts a registration application shall, within 3 working days from the date of accepting the registration application, transfer the registration application materials to the technical review institution. The technical review institution shall, upon completing the technical review, submit its review opinion to the drug regulatory department that accepted the registration application as the basis for approval.

Where the drug regulatory department that accepts a registration application considers it necessary to conduct an inspection of the quality management system when organizing the technical review of the medical device, it shall organize an inspection of the quality management system.

Article 18. The drug regulatory department that accepts a registration application shall make a decision within 20 working days from the date of receipt of the review opinion. Where the conditions are met, registration shall be granted and a medical device registration certificate shall be issued; where the conditions are not met, registration shall not be granted and the reasons shall be stated in writing.

The drug regulatory department that accepts a registration application shall, within 5 working days from the date on which registration of the medical device is granted, make the relevant registration information public through the online government service platform of the drug regulatory department of the State Council.

Article 19. For medical devices urgently needed for the treatment of rare diseases, diseases that seriously endanger life and for which there is no effective means of treatment, and the response to public health events, the drug regulatory department that accepts a registration application may make a decision of conditional approval, and shall set forth the relevant matters in the medical device registration certificate.

Where a particularly major public health emergency or other emergency that seriously threatens public health occurs, the competent health department of the State Council and the disease prevention and control department of the State Council shall, according to the needs of preventing and controlling the event, put forward a proposal for the emergency use of a medical device, which may, upon the organization of demonstration and consent by the drug regulatory department of the State Council, be used on an emergency basis within a certain scope and time limit.

Article 20. A medical device registrant or filing person shall perform the following obligations:

(I) establish a quality management system commensurate with the product and keep it in effective operation;

(II) formulate post-market research and risk control plans and ensure their effective implementation;

(III) carry out adverse-event monitoring and re-evaluation in accordance with the law;

(IV) establish and implement product traceability and recall systems;

(V) other obligations prescribed by the drug regulatory department of the State Council.

The enterprise legal person within China designated by an overseas medical device registrant or filing person shall assist the registrant or filing person in performing the obligations prescribed in the preceding paragraph.

Article 21. Where the design, raw materials, manufacturing process, scope of application, method of use and the like of a registered Class II or Class III medical device product undergo substantive changes that may affect the safety and effectiveness of the medical device, the registrant shall apply to the original registration department for alteration of registration formalities; where other changes occur, filing or reporting shall be made in accordance with the provisions of the drug regulatory department of the State Council.

Article 22. The medical device registration certificate shall be valid for 5 years. Where renewal of registration is needed upon expiry of the validity period, an application for renewal of registration shall be filed with the original registration department 6 months before the expiry of the validity period.

Except where the circumstances prescribed in the third paragraph of this Article exist, the drug regulatory department that receives an application for renewal of registration shall make a decision to grant renewal before the expiry of the validity period of the medical device registration certificate. Where no decision is made within the time limit, renewal shall be deemed granted.

Under any of the following circumstances, renewal of registration shall not be granted:

(I) the application for renewal of registration is not filed within the prescribed time limit;

(II) the mandatory standard for the medical device has been revised, and the medical device for which renewal of registration is applied cannot meet the new requirements;

(III) for a conditionally approved medical device, the matters set forth in the medical device registration certificate have not been completed within the prescribed time limit.

Article 23. For a newly researched and developed medical device that has not yet been included in the classification catalogue, the applicant may directly apply for product registration in accordance with the provisions of this Regulation on the registration of Class III medical device products, or may determine the product category in accordance with the classification rules and apply for product registration or conduct product filing in accordance with the provisions of this Regulation after applying to the drug regulatory department of the State Council for confirmation of the category.

Where direct application for registration of a Class III medical device product is made, the drug regulatory department of the State Council shall determine the category according to the degree of risk, and promptly include the medical device for which registration is granted in the classification catalogue. Where confirmation of category is applied for, the drug regulatory department of the State Council shall, within 20 working days from the date of accepting the application, determine the category of the medical device and notify the applicant.

Article 24. Clinical evaluation shall be conducted for the registration and filing of medical device products; however, under any of the following circumstances, clinical evaluation may be exempted:

(I) the working mechanism is clear, the design is finalized, the manufacturing process is mature, a marketed medical device of the same variety has been used clinically for many years without any record of serious adverse events, and the routine use is not changed;

(II) the safety and effectiveness of the medical device can otherwise be proven through non-clinical evaluation.

The drug regulatory department of the State Council shall formulate guidelines for the clinical evaluation of medical devices.

Article 25. Clinical evaluation of a medical device may, according to such circumstances as product characteristics, clinical risks and existing clinical data, prove the safety and effectiveness of the medical device by conducting clinical trials, or by analyzing and evaluating clinical literature and clinical data of medical devices of the same variety.

In accordance with the provisions of the drug regulatory department of the State Council, clinical trials shall be conducted for medical devices whose safety and effectiveness cannot be confirmed on the basis of existing clinical literature and clinical data when clinical evaluation is conducted.

Article 26. Clinical trials of medical devices shall be conducted in clinical trial institutions that meet the corresponding conditions in accordance with the requirements of the good clinical practice for medical device clinical trials, and shall be filed with the drug regulatory department of the people’s government of the province, autonomous region or municipality directly under the Central Government where the sponsor of the clinical trial is located. The drug regulatory department that accepts the filing of a clinical trial shall notify the drug regulatory department and the competent health department at the same level in the place where the clinical trial institution is located of the filing.

Clinical trial institutions for medical devices shall be subject to filing administration. The conditions that clinical trial institutions for medical devices shall meet, the measures for filing administration, and the good clinical practice for clinical trials shall be formulated and published by the drug regulatory department of the State Council in conjunction with the competent health department of the State Council.

The State shall support medical institutions in conducting clinical trials, incorporate the evaluation of clinical trial conditions and capabilities into the grading and accreditation of medical institutions, and encourage medical institutions to conduct clinical trials of innovative medical devices.

Article 27. Where a clinical trial of a Class III medical device poses a relatively high risk to the human body, it shall be approved by the drug regulatory department of the State Council. In approving a clinical trial, the drug regulatory department of the State Council shall comprehensively analyze the conditions such as equipment and professional personnel of the institution proposed to undertake the medical device clinical trial, the degree of risk of the medical device, the implementation plan of the clinical trial, and the report on the comparative analysis of clinical benefit and risk, and shall make a decision within 60 working days from the date of accepting the application and notify the sponsor of the clinical trial. Where no notification is given within the time limit, consent shall be deemed to have been given. Where the conduct of a clinical trial is granted, the drug regulatory department and the competent health department of the people’s government of the province, autonomous region or municipality directly under the Central Government where the clinical trial institution is located shall be notified.

The catalogue of Class III medical devices whose clinical trials pose a relatively high risk to the human body shall be formulated, adjusted and published by the drug regulatory department of the State Council.

Article 28. In conducting a clinical trial of a medical device, ethical review shall be conducted in accordance with provisions, the subject shall be informed in detail of the purpose and use of the trial and the risks that may arise, and the written informed consent of the subject shall be obtained; where the subject is a person without capacity for civil conduct or with limited capacity for civil conduct, the written informed consent of his or her guardian shall be obtained in accordance with the law.

In conducting a clinical trial, no fees related to the clinical trial may be charged to the subject in any form.

Article 29. For a medical device undergoing a clinical trial for the treatment of a disease that seriously endangers life and for which there is no effective means of treatment, where medical observation indicates that the patient may benefit, the device may, upon ethical review and informed consent, be used free of charge within the institution conducting the medical device clinical trial for other patients with the same condition, and its safety data may be used for the medical device registration application.

Chapter 3 Manufacture of Medical Devices

Article 30. Engaging in the manufacturing activities of medical devices shall meet the following conditions:

(I) having a manufacturing site, environmental conditions, manufacturing equipment and professional technical personnel commensurate with the medical devices to be manufactured;

(II) having an institution or full-time inspection personnel capable of conducting quality inspection of the medical devices to be manufactured, as well as inspection equipment;

(III) having a management system to ensure the quality of medical devices;

(IV) having after-sales service capabilities commensurate with the medical devices to be manufactured;

(V) complying with the requirements set forth in the product research and manufacturing process documents.

Article 31. To engage in the manufacture of Class I medical devices, a filing shall be made with the department responsible for drug regulation under the people’s government of the city divided into districts where it is located, and the filing is completed upon submission of the relevant materials that meet the conditions prescribed in Article 30 of this Regulation.

Where a medical device filing person manufactures Class I medical devices by itself, it may, when conducting product filing in accordance with Article 15 of this Regulation, simultaneously submit the relevant materials that meet the conditions prescribed in Article 30 of this Regulation, and the manufacturing filing is thereby completed.

Article 32. To engage in the manufacture of Class II or Class III medical devices, an application for a manufacturing license shall be filed with the drug regulatory department of the people’s government of the province, autonomous region or municipality directly under the Central Government where it is located, together with the relevant materials that meet the conditions prescribed in Article 30 of this Regulation and the registration certificate of the medical devices to be manufactured.

The drug regulatory department that accepts an application for a manufacturing license shall review the application materials, conduct an inspection in accordance with the requirements of the good manufacturing practice for medical devices formulated by the drug regulatory department of the State Council, and make a decision within 20 working days from the date of accepting the application. Where the prescribed conditions are met, the license shall be granted and a medical device manufacturing license shall be issued; where the prescribed conditions are not met, the license shall not be granted and the reasons shall be stated in writing.

The medical device manufacturing license shall be valid for 5 years. Where renewal is needed upon expiry of the validity period, renewal formalities shall be handled in accordance with the legal provisions on administrative licensing.

Article 33. The good manufacturing practice for medical devices shall make explicit provisions on matters affecting the safety and effectiveness of medical devices, such as the design and development, manufacturing equipment conditions, raw material procurement, manufacturing process control, product release, and the institutional setup and staffing of enterprises.

Article 34. A medical device registrant or filing person may manufacture medical devices by itself, or may entrust an enterprise that complies with the provisions of this Regulation and possesses the corresponding conditions to manufacture medical devices.

Where the manufacture of medical devices is entrusted, the medical device registrant or filing person shall be responsible for the quality of the entrusted medical devices, strengthen the management of the manufacturing conduct of the entrusted manufacturing enterprise, and ensure that it manufactures in accordance with statutory requirements. The medical device registrant or filing person shall sign an entrustment agreement with the entrusted manufacturing enterprise, specifying the rights, obligations and responsibilities of both parties. The entrusted manufacturing enterprise shall organize manufacture in accordance with laws and regulations, the good manufacturing practice for medical devices, mandatory standards, product technical requirements and the entrustment agreement, be responsible for its manufacturing conduct, and accept the supervision of the entrusting party.

High-risk implantable medical devices shall not be manufactured under entrustment; the specific catalogue shall be formulated, adjusted and published by the drug regulatory department of the State Council.

Article 35. Medical device registrants, filing persons and entrusted manufacturing enterprises shall, in accordance with the good manufacturing practice for medical devices, establish and improve a quality management system commensurate with the medical devices manufactured and ensure its effective operation; they shall organize manufacture strictly in accordance with the registered or filed product technical requirements, and ensure that the medical devices leaving the factory comply with the mandatory standards and the registered or filed product technical requirements.

Medical device registrants, filing persons and entrusted manufacturing enterprises shall periodically conduct self-inspections of the operation of the quality management system, and submit self-inspection reports in accordance with the provisions of the drug regulatory department of the State Council.

Article 36. Where the manufacturing conditions of a medical device change and no longer comply with the requirements of the medical device quality management system, the medical device registrant, filing person or entrusted manufacturing enterprise shall immediately take rectification measures; where the safety and effectiveness of the medical device may be affected, it shall immediately stop manufacturing activities and report to the original manufacturing license or manufacturing filing department.

Article 37. Medical devices shall use generic names. Generic names shall comply with the medical device naming rules formulated by the drug regulatory department of the State Council.

Article 38. The State shall, according to the categories of medical device products, implement the unique device identification system for medical devices step by step, so as to achieve the traceability of medical devices. The specific measures shall be formulated by the drug regulatory department of the State Council in conjunction with the relevant departments of the State Council.

Article 39. Medical devices shall have instructions for use and labels. The content of the instructions for use and labels shall be consistent with the relevant registered or filed content, and shall be authentic and accurate.

The instructions for use and labels of medical devices shall indicate the following matters:

(I) generic name, model and specifications;

(II) the name, address and contact information of the medical device registrant, filing person, or entrusted manufacturing enterprise;

(III) date of manufacture, period of use or expiry date;

(IV) product performance, main structure and scope of application;

(V) contraindications, precautions and other content requiring warning or notice;

(VI) installation and use instructions or illustrations;

(VII) maintenance and care methods, and conditions and methods for special transportation and storage;

(VIII) other content required to be indicated by the product technical requirements.

Class II and Class III medical devices shall also indicate the medical device registration certificate number.

Medical devices used by consumers themselves shall also have special instructions for safe use.

Chapter 4 Distribution and Use of Medical Devices

Article 40. Engaging in the distribution activities of medical devices shall require business premises and storage conditions commensurate with the scale and scope of business, as well as a quality management system and a quality management institution or personnel commensurate with the medical devices distributed.

Article 41. To engage in the distribution of Class II medical devices, the distribution enterprise shall make a filing with the department responsible for drug regulation under the people’s government of the city divided into districts where it is located and submit the relevant materials that meet the conditions prescribed in Article 40 of this Regulation.

In accordance with the provisions of the drug regulatory department of the State Council, Class II medical devices whose safety and effectiveness are not affected by the distribution process may be exempted from distribution filing.

Article 42. To engage in the distribution of Class III medical devices, the distribution enterprise shall apply to the department responsible for drug regulation under the people’s government of the city divided into districts where it is located for a distribution license and submit the relevant materials that meet the conditions prescribed in Article 40 of this Regulation.

The department responsible for drug regulation that accepts an application for a distribution license shall review the application materials, organize an inspection where necessary, and make a decision within 20 working days from the date of accepting the application. Where the prescribed conditions are met, the license shall be granted and a medical device distribution license shall be issued; where the prescribed conditions are not met, the license shall not be granted and the reasons shall be stated in writing.

The medical device distribution license shall be valid for 5 years. Where renewal is needed upon expiry of the validity period, renewal formalities shall be handled in accordance with the legal provisions on administrative licensing.

Article 43. Where a medical device registrant or filing person distributes the medical devices it has registered or filed, it need not handle a medical device distribution license or filing, but shall comply with the distribution conditions prescribed in this Regulation.

Article 44. To engage in the distribution of medical devices, the enterprise shall, in accordance with laws and regulations and the requirements of the good distribution practice for medical devices formulated by the drug regulatory department of the State Council, establish and improve a quality management system commensurate with the medical devices distributed and ensure its effective operation.

Article 45. Medical device distribution enterprises and use entities shall purchase medical devices from medical device registrants, filing persons, and manufacturing and distribution enterprises with lawful qualifications. When purchasing medical devices, they shall verify the qualifications of the suppliers and the certification documents of conformity of the medical devices, and establish an incoming inspection record system. Distribution enterprises engaged in the wholesale business of Class II and Class III medical devices and the retail business of Class III medical devices shall also establish a sales record system.

The matters to be recorded include:

(I) the name, model, specifications and quantity of the medical device;

(II) the manufacturing batch number, period of use or expiry date, and date of sale of the medical device;

(III) the names of the medical device registrant, filing person, and entrusted manufacturing enterprise;

(IV) the name, address and contact information of the supplier or purchaser;

(V) the number of the relevant licensing certification document and the like.

Incoming inspection records and sales records shall be authentic, accurate, complete and traceable, and shall be preserved for the period prescribed by the drug regulatory department of the State Council. The State shall encourage the use of advanced technical means for record-keeping.

Article 46. Those engaged in the online sale of medical devices shall be medical device registrants, filing persons or medical device distribution enterprises. Operators engaged in the online sale of medical devices shall notify the department responsible for drug regulation under the people’s government of the city divided into districts where they are located of the relevant information on their online sale of medical devices, except for the distribution of Class I medical devices and the Class II medical devices prescribed in the second paragraph of Article 41 of this Regulation.

E-commerce platform operators that provide services for the online trading of medical devices shall conduct real-name registration of the medical device operators that join the platform, review their distribution licenses, filing status, and the product registration and filing status of the medical devices they distribute, and manage their distribution conduct. Where an e-commerce platform operator discovers that a medical device operator that has joined the platform has committed an act in violation of the provisions of this Regulation, it shall promptly stop it and immediately report to the department responsible for drug regulation under the people’s government of the city divided into districts where the medical device operator is located; where it discovers a serious illegal act, it shall immediately stop providing online trading platform services.

Article 47. The transportation and storage of medical devices shall comply with the requirements indicated in the instructions for use and labels of the medical devices; where there are special requirements for environmental conditions such as temperature and humidity, corresponding measures shall be taken to ensure the safety and effectiveness of the medical devices.

Article 48. Medical device use entities shall have storage sites and conditions commensurate with the varieties and quantities of medical devices in use. Medical device use entities shall strengthen the technical training of their staff, and use medical devices in accordance with the requirements of the product instructions for use and technical operating procedures.

Where a medical device use entity is equipped with large medical equipment, it shall comply with the planning for the allocation of large medical equipment formulated by the competent health department of the State Council, be commensurate with its functional positioning and clinical service needs, have the corresponding technical conditions, supporting facilities and professional technical personnel with the corresponding qualifications and capabilities, and obtain a license for the allocation of large medical equipment upon the approval of the competent health department of the people’s government at or above the provincial level.

The measures for the administration of the allocation of large medical equipment shall be formulated by the competent health department of the State Council in conjunction with the relevant departments of the State Council. The catalogue of large medical equipment shall be proposed by the competent health department of the State Council in consultation with the relevant departments of the State Council, and shall be implemented after being submitted to and approved by the State Council.

Article 49. For reusable medical devices, medical device use entities shall handle them in accordance with the provisions on disinfection and management formulated by the competent health department of the State Council.

Single-use medical devices shall not be reused; used ones shall be destroyed and recorded in accordance with relevant State provisions. The catalogue of single-use medical devices shall be formulated, adjusted and published by the drug regulatory department of the State Council in conjunction with the competent health department of the State Council. Inclusion in the catalogue of single-use medical devices shall have sufficient evidentiary grounds that reuse is not possible. Medical devices whose safety and effectiveness can be ensured by reuse shall not be included in the catalogue of single-use medical devices. For medical devices whose safety and effectiveness can be ensured by reuse following improvements in design, manufacturing process, disinfection and sterilization technology and the like, they shall be adjusted out of the catalogue of single-use medical devices and reuse shall be permitted.

Article 50. For medical devices that require periodic inspection, testing, calibration, care and maintenance, medical device use entities shall conduct inspection, testing, calibration, care and maintenance in accordance with the requirements of the product instructions for use and keep records, and shall promptly conduct analysis and assessment to ensure that the medical devices are in good condition and to safeguard the quality of use; for large medical devices with a long period of use, a use archive shall be established for each unit, recording matters such as its use, maintenance, transfer, and actual time of use. The period for preserving records shall not be less than 5 years after the expiry of the prescribed period of use of the medical device.

Article 51. Medical device use entities shall properly preserve the original materials for the purchase of Class III medical devices, and ensure that the information is traceable.

For the use of large medical devices as well as implantable and interventional medical devices, information such as the name and key technical parameters of the medical device, as well as the necessary information closely related to the quality and safety of use, shall be recorded in the medical records and other relevant records.

Article 52. Where it is discovered that a medical device in use poses a safety hazard, the medical device use entity shall immediately stop using it and notify the medical device registrant, filing person or other institution responsible for product quality to carry out repair; medical devices that still fail to meet the safety standards for use after repair shall not continue to be used.

Article 53. For in vitro diagnostic reagents for which there is no product of the same variety marketed within China, qualified medical institutions may, according to the clinical needs of their own entities, develop them themselves and use them within their own entities under the guidance of licensed physicians. The specific administrative measures shall be formulated by the drug regulatory department of the State Council in conjunction with the competent health department of the State Council.

Article 54. The department responsible for drug regulation and the competent health department shall, in accordance with their respective responsibilities, separately conduct supervision and administration of the quality of medical devices in the use stage and of the medical device use conduct.

Article 55. Medical device distribution enterprises and use entities shall not distribute or use medical devices that have not been registered or filed in accordance with the law, that lack certification documents of conformity, or that are expired, ineffective or obsolete.

Article 56. Where medical device use entities transfer medical devices in use between one another, the transferring party shall ensure that the transferred medical devices are safe and effective, and shall not transfer medical devices that are expired, ineffective, obsolete, or that fail inspection.

Article 57. Imported medical devices shall be medical devices that have been registered or filed in accordance with the provisions of Chapter 2 of this Regulation.

Imported medical devices shall have instructions for use and labels in Chinese. The instructions for use and labels shall comply with the provisions of this Regulation and the requirements of the relevant mandatory standards, and the instructions for use shall set forth the place of origin of the medical device as well as the name, address and contact information of the enterprise legal person within China designated by the overseas medical device registrant or filing person. Where there are no Chinese instructions for use or Chinese labels, or the instructions for use or labels do not comply with the provisions of this Article, importation shall not be permitted.

Where a medical institution imports a small quantity of Class II or Class III medical devices due to urgent clinical needs, importation may be made upon the approval of the drug regulatory department of the State Council or the people’s government of the province, autonomous region or municipality directly under the Central Government authorized by the State Council. The imported medical devices shall be used within the designated medical institution for specific medical purposes.

The importation of expired, ineffective, obsolete and other used medical devices is prohibited.

Article 58. The entry-exit inspection and quarantine institutions shall conduct inspection of imported medical devices in accordance with the law; those that fail inspection shall not be imported.

The drug regulatory department of the State Council shall promptly notify the national entry-exit inspection and quarantine department of the registration and filing status of imported medical devices. The entry-exit inspection and quarantine institution at the port of entry shall promptly notify the department responsible for drug regulation under the people’s government of the city divided into districts where it is located of the customs clearance status of imported medical devices.

Article 59. Enterprises exporting medical devices shall ensure that the medical devices they export comply with the requirements of the importing country (or region).

Article 60. The content of medical device advertisements shall be authentic and lawful, shall be based on the medical device instructions for use registered with or filed with the department responsible for drug regulation, and shall not contain false, exaggerated or misleading content.

To publish a medical device advertisement, the content of the advertisement shall, before publication, be reviewed by the advertisement review authority determined by the people’s government of the province, autonomous region or municipality directly under the Central Government, and a medical device advertisement approval number shall be obtained; without review, it shall not be published.

For medical devices whose manufacture, importation, distribution and use the drug regulatory department of the people’s government at or above the provincial level has ordered to be suspended, advertisements involving such medical devices shall not be published during the period of suspension.

The measures for the review of medical device advertisements shall be formulated by the market regulatory department of the State Council.

Chapter 5 Handling of Adverse Events and Recall of Medical Devices

Article 61. The State shall establish a medical device adverse-event monitoring system to promptly collect, analyze, evaluate and control medical device adverse events.

Article 62. Medical device registrants and filing persons shall establish a medical device adverse-event monitoring system, be equipped with adverse-event monitoring institutions and personnel commensurate with their products, proactively carry out adverse-event monitoring of their products, and, in accordance with the provisions of the drug regulatory department of the State Council, report to the medical device adverse-event monitoring technical institution on the investigation, analysis, evaluation, product risk control and the like.

Medical device manufacturing and distribution enterprises and use entities shall assist medical device registrants and filing persons in carrying out adverse-event monitoring of the medical devices they manufacture, distribute or use; upon discovering a medical device adverse event or a suspected adverse event, they shall report to the medical device adverse-event monitoring technical institution in accordance with the provisions of the drug regulatory department of the State Council.

Other entities and individuals that discover a medical device adverse event or a suspected adverse event shall have the right to report to the department responsible for drug regulation or the medical device adverse-event monitoring technical institution.

Article 63. The drug regulatory department of the State Council shall strengthen the construction of the information network for medical device adverse-event monitoring.

Medical device adverse-event monitoring technical institutions shall strengthen the monitoring of medical device adverse-event information and proactively collect adverse-event information; upon discovering an adverse event or receiving a report of an adverse event, they shall promptly verify it, conduct investigation, analysis and assessment where necessary, report to the department responsible for drug regulation and the competent health department, and put forward handling suggestions.

Medical device adverse-event monitoring technical institutions shall publish their contact information to facilitate the reporting of medical device adverse events by medical device registrants, filing persons, manufacturing and distribution enterprises, use entities and others.

Article 64. The department responsible for drug regulation shall, according to the results of the assessment of medical device adverse events, promptly take control measures such as issuing warning information and ordering the suspension of manufacture, importation, distribution and use.

The drug regulatory department of the people’s government at or above the provincial level shall, in conjunction with the competent health department at the same level and the relevant departments, organize the prompt investigation and handling of medical device adverse events causing sudden or mass serious injuries or deaths, and organize the strengthening of monitoring of medical devices of the same kind.

The department responsible for drug regulation shall promptly notify the competent health department at the same level of the relevant situation concerning adverse-event monitoring at medical device use entities.

Article 65. Medical device registrants, filing persons, manufacturing and distribution enterprises, and use entities shall cooperate with the investigations of medical device adverse events conducted by medical device adverse-event monitoring technical institutions, the departments responsible for drug regulation, and the competent health departments.

Article 66. Under any of the following circumstances, a medical device registrant or filing person shall proactively carry out re-evaluation of a marketed medical device:

(I) there is a change in the understanding of the safety and effectiveness of the medical device in light of the development of scientific research;

(II) the results of medical device adverse-event monitoring and assessment indicate that the medical device may have defects;

(III) other circumstances prescribed by the drug regulatory department of the State Council.

A medical device registrant or filing person shall, according to the re-evaluation results, take corresponding control measures, improve the marketed medical device, and handle the alteration of registration or filing in accordance with provisions. Where the re-evaluation results indicate that the marketed medical device cannot ensure safety and effectiveness, the medical device registrant or filing person shall proactively apply for cancellation of the medical device registration certificate or cancellation of the filing; where the medical device registrant or filing person does not apply for cancellation of the medical device registration certificate or cancellation of the filing, the department responsible for drug regulation shall cancel the medical device registration certificate or cancel the filing.

The drug regulatory department of the people’s government at or above the provincial level shall, according to such circumstances as medical device adverse-event monitoring and assessment, carry out re-evaluation of marketed medical devices. Where the re-evaluation results indicate that a marketed medical device cannot ensure safety and effectiveness, the medical device registration certificate shall be canceled or the filing shall be canceled.

The department responsible for drug regulation shall promptly make public the cancellation of medical device registration certificates and the cancellation of filings. Medical devices whose registration certificates have been canceled or whose filings have been canceled shall not continue to be manufactured, imported, distributed or used.

Article 67. Where a medical device registrant or filing person discovers that a medical device manufactured does not comply with the mandatory standards or the registered or filed product technical requirements, or has other defects, it shall immediately stop manufacture, notify the relevant distribution enterprises, use entities and consumers to stop distribution and use, recall the medical devices already marketed and sold, take remedial, destruction and other measures, record the relevant situation, publish the relevant information, and report the recall and handling of the medical devices to the department responsible for drug regulation and the competent health department.

Where a medical device entrusted manufacturing enterprise or distribution enterprise discovers that a medical device it manufactures or distributes is in any of the circumstances prescribed in the preceding paragraph, it shall immediately stop manufacture or distribution, notify the medical device registrant or filing person, and record the cessation of manufacture or distribution and the notification. Where the medical device registrant or filing person considers that the medical device is one that needs to be recalled in accordance with the provisions of the preceding paragraph, it shall immediately recall it.

Where a medical device registrant, filing person, entrusted manufacturing enterprise or distribution enterprise fails to carry out a recall or stop manufacture or distribution in accordance with the provisions of this Article, the department responsible for drug regulation may order it to carry out the recall or stop manufacture or distribution.

Chapter 6 Supervision and Inspection

Article 68. The State shall establish a professional and specialized inspector system to strengthen the supervision and inspection of medical devices.

Article 69. The department responsible for drug regulation shall strengthen the supervision and inspection of the research, manufacture and distribution activities of medical devices as well as the quality of medical devices in the use stage, and shall conduct key supervision and inspection of the following matters:

(I) whether manufacture is organized in accordance with the registered or filed product technical requirements;

(II) whether the quality management system is kept in effective operation;

(III) whether the manufacturing and distribution conditions continuously comply with statutory requirements.

Where necessary, the department responsible for drug regulation may conduct extended inspection of other relevant entities and individuals that provide products or services for the research, manufacture, distribution, use and other activities of medical devices.

Article 70. In supervision and inspection, the department responsible for drug regulation shall have the following powers:

(I) to enter the site to conduct inspection and take samples;

(II) to consult, copy, seal up and seize relevant contracts, invoices, account books and other relevant materials;

(III) to seal up and seize medical devices that do not meet statutory requirements, parts and components and raw materials used illegally, as well as tools and equipment used for the illegal manufacture and distribution of medical devices;

(IV) to seal up sites where medical device manufacturing and distribution activities are conducted in violation of the provisions of this Regulation.

In conducting supervision and inspection, law-enforcement certificates shall be presented, and the commercial secrets of the inspected entity shall be kept confidential.

The relevant entities and individuals shall cooperate with supervision and inspection, provide relevant documents and materials, and shall not conceal, refuse or obstruct.

Article 71. The competent health department shall strengthen supervision and inspection of the medical device use conduct of medical institutions. When conducting supervision and inspection, it may enter the medical institution and consult and copy relevant archives, records and other relevant materials.

Article 72. Where there is a hidden hazard to product quality and safety in the process of medical device manufacture and distribution that is not promptly eliminated through measures, the department responsible for drug regulation may take such measures as admonition, responsibility interview, and ordering rectification within a time limit.

For medical devices that have caused harm to the human body or for which there is evidence proving that they may endanger human health, the department responsible for drug regulation may take emergency control measures such as ordering the suspension of manufacture, importation, distribution and use, and issue safety warning information.

Article 73. The department responsible for drug regulation shall strengthen spot-check inspection of the medical devices manufactured, distributed and used by medical device registrants, filing persons, manufacturing and distribution enterprises, and use entities. No inspection fees or any other fees shall be charged for spot-check inspection, and the necessary expenses shall be incorporated into the budget of the government at the same level. The drug regulatory department of the people’s government at or above the provincial level shall promptly issue medical device quality bulletins according to the conclusions of spot-check inspection.

The competent health department shall supervise and assess the use status of large medical equipment; upon discovering irregular use as well as excessive examination, excessive treatment and the like related to large medical equipment, it shall immediately correct it and handle it in accordance with the law.

Article 74. Where the department responsible for drug regulation fails to promptly discover systemic risks to medical device safety, or fails to promptly eliminate hidden hazards to medical device safety within its supervision and administration area, the people’s government at the same level or the department responsible for drug regulation under the people’s government at the higher level shall conduct an interview with its principal person in charge.

Where a local people’s government fails to perform its responsibilities for medical device safety, or fails to promptly eliminate regional major hidden hazards to medical device safety, the people’s government at the higher level or the department responsible for drug regulation under the people’s government at the higher level shall conduct an interview with its principal person in charge.

The interviewed department and local people’s government shall immediately take measures to rectify the supervision and administration of medical devices.

Article 75. The qualification accreditation of medical device inspection institutions shall be subject to unified administration in accordance with relevant State provisions. Only inspection institutions accredited by the certification and accreditation regulatory department of the State Council in conjunction with the drug regulatory department of the State Council may conduct inspection of medical devices.

Where the department responsible for drug regulation needs to conduct inspection of medical devices in its law-enforcement work, it shall entrust a qualified medical device inspection institution to conduct the inspection and pay the relevant expenses.

Where a party has an objection to the inspection conclusion, it may, within 7 working days from the date of receipt of the inspection conclusion, file an application for re-inspection with the department that conducted the spot-check inspection or the department responsible for drug regulation at the next higher level, and the department that accepts the application for re-inspection shall randomly determine a re-inspection institution from the list of re-inspection institutions to conduct the re-inspection. The medical device inspection institution undertaking the re-inspection work shall make a re-inspection conclusion within the time prescribed by the drug regulatory department of the State Council. The re-inspection conclusion shall be the final inspection conclusion. The re-inspection institution and the initial inspection institution shall not be the same institution; where there is only one qualified inspection institution for the relevant inspection item, the undertaking department or personnel shall be changed for the re-inspection. The list of re-inspection institutions shall be published by the drug regulatory department of the State Council.

Article 76. For medical devices that may contain harmful substances, or that have had their design, raw materials and manufacturing process altered without authorization and pose hidden safety hazards, and that cannot be inspected according to the inspection items and inspection methods prescribed in the national standards and industry standards for medical devices, the medical device inspection institution may use supplementary inspection items and inspection methods approved by the drug regulatory department of the State Council to conduct the inspection; the inspection conclusions arrived at using the supplementary inspection items and inspection methods may serve as the basis for the department responsible for drug regulation to determine the quality of medical devices.

Article 77. The market regulatory department shall, in accordance with the provisions of relevant laws and administrative regulations on advertising administration, conduct supervision and inspection of medical device advertisements, and investigate and deal with illegal acts.

Article 78. The department responsible for drug regulation shall, through the online government service platform of the drug regulatory department of the State Council, promptly publish, in accordance with the law, routine supervision and administration information such as the licensing, filing, spot-check inspection, and investigation and handling of illegal acts of medical devices. However, the commercial secrets of the parties shall not be divulged.

The department responsible for drug regulation shall establish credit archives for medical device registrants, filing persons, manufacturing and distribution enterprises, and use entities, increase the frequency of supervision and inspection of those with bad credit records, and strengthen punishment for breach of trust in accordance with the law.

Article 79. The department responsible for drug regulation and other departments shall publish the contact information of their own entities and accept consultations, complaints and reports. Upon receiving a consultation related to the supervision and administration of medical devices, the department responsible for drug regulation and other departments shall promptly reply; upon receiving a complaint or report, they shall promptly verify, handle and reply. The consultations, complaints and reports and their replies, verification and handling shall be recorded and preserved.

Where a report concerning the research, manufacture, distribution or use conduct of medical devices is verified to be true upon investigation, the department responsible for drug regulation and other departments shall reward the whistleblower. The relevant departments shall keep the whistleblower confidential.

Article 80. Where the drug regulatory department of the State Council formulates, adjusts or amends the catalogues prescribed in this Regulation and the norms related to the supervision and administration of medical devices, it shall publicly solicit opinions; and shall, by means of hearings, demonstration meetings and the like, hear the opinions of experts, medical device registrants, filing persons, manufacturing and distribution enterprises, use entities, consumers, industry associations and relevant organizations.

Chapter 7 Legal Liability

Article 81. Under any of the following circumstances, the department responsible for drug regulation shall confiscate the illegal gains, the medical devices illegally manufactured or distributed, and the tools, equipment, raw materials and other articles used for illegal manufacture or distribution; where the value of the medical devices illegally manufactured or distributed is less than RMB 10,000, a fine of not less than RMB 50,000 but not more than RMB 150,000 shall be imposed concurrently; where the value is RMB 10,000 or more, a fine of not less than 15 times but not more than 30 times the value shall be imposed concurrently; where the circumstances are serious, it shall order the suspension of production and business, shall not accept the medical device licensing applications filed by the relevant responsible persons and entities within 10 years, confiscate from the legal representative, principal person in charge, the directly responsible person in charge and other responsible persons of the illegal entity the income obtained from the entity during the period of the illegal act, and impose on them a fine of not less than 30% but not more than 3 times the income obtained, and permanently prohibit them from engaging in the manufacturing and distribution activities of medical devices:

(I) manufacturing or distributing Class II or Class III medical devices for which no medical device registration certificate has been obtained;

(II) engaging in the manufacturing activities of Class II or Class III medical devices without a license;

(III) engaging in the distribution activities of Class III medical devices without a license.

Where the circumstance under item (I) of the preceding paragraph exists and the circumstances are serious, the original certificate-issuing department shall revoke the medical device manufacturing license or the medical device distribution license.

Article 82. Where large medical equipment is allocated and used without authorization in the absence of a license, the competent health department of the people’s government at or above the county level shall order the cessation of use, give a warning, and confiscate the illegal gains; where the illegal gains are less than RMB 10,000, a fine of not less than RMB 50,000 but not more than RMB 100,000 shall be imposed concurrently; where the illegal gains are RMB 10,000 or more, a fine of not less than 10 times but not more than 30 times the illegal gains shall be imposed concurrently; where the circumstances are serious, the applications for licenses for the allocation of large medical equipment filed by the relevant responsible persons and entities shall not be accepted within 5 years, the income obtained from the entity during the period of the illegal act shall be confiscated from the legal representative, principal person in charge, the directly responsible person in charge and other responsible persons of the illegal entity, a fine of not less than 30% but not more than 3 times the income obtained shall be imposed on them, and sanctions shall be given in accordance with the law.

Article 83. Where false materials are provided or other fraudulent means are adopted in applying for medical device administrative licensing, the administrative licensing shall not be granted; where the administrative licensing has been obtained, the department that made the administrative licensing decision shall revoke the administrative licensing, confiscate the illegal gains and the medical devices illegally manufactured, distributed or used, and shall not accept the medical device licensing applications filed by the relevant responsible persons and entities within 10 years; where the value of the medical devices illegally manufactured, distributed or used is less than RMB 10,000, a fine of not less than RMB 50,000 but not more than RMB 150,000 shall be imposed concurrently; where the value is RMB 10,000 or more, a fine of not less than 15 times but not more than 30 times the value shall be imposed concurrently; where the circumstances are serious, it shall order the suspension of production and business, confiscate from the legal representative, principal person in charge, the directly responsible person in charge and other responsible persons of the illegal entity the income obtained from the entity during the period of the illegal act, impose on them a fine of not less than 30% but not more than 3 times the income obtained, and permanently prohibit them from engaging in the manufacturing and distribution activities of medical devices.

Where relevant medical device licensing certificates are forged, altered, bought, sold, leased or lent, the original certificate-issuing department shall confiscate or revoke them and confiscate the illegal gains; where the illegal gains are less than RMB 10,000, a fine of not less than RMB 50,000 but not more than RMB 100,000 shall be imposed concurrently; where the illegal gains are RMB 10,000 or more, a fine of not less than 10 times but not more than 20 times the illegal gains shall be imposed concurrently; where an act in violation of public security administration is constituted, the public security organ shall impose public security administration punishment in accordance with the law.

Article 84. Under any of the following circumstances, the department responsible for drug regulation shall make a public announcement of the names of the entity and product to the public, and order rectification within a time limit; where rectification is not made within the time limit, it shall confiscate the illegal gains and the medical devices illegally manufactured or distributed; where the value of the medical devices illegally manufactured or distributed is less than RMB 10,000, a fine of not less than RMB 10,000 but not more than RMB 50,000 shall be imposed concurrently; where the value is RMB 10,000 or more, a fine of not less than 5 times but not more than 20 times the value shall be imposed concurrently; where the circumstances are serious, the income obtained from the entity during the period of the illegal act shall be confiscated from the legal representative, principal person in charge, the directly responsible person in charge and other responsible persons of the illegal entity, a fine of not less than 30% but not more than 2 times the income obtained shall be imposed on them, and they shall be prohibited from engaging in the manufacturing and distribution activities of medical devices within 5 years:

(I) manufacturing or distributing Class I medical devices that have not been filed;

(II) engaging in the manufacture of Class I medical devices without filing;

(III) distributing Class II medical devices that should be filed but have not been filed;

(IV) the filed materials do not meet the requirements.

Article 85. Where false materials are provided at the time of filing, the department responsible for drug regulation shall make a public announcement of the names of the filing entity and product to the public, and confiscate the illegal gains and the medical devices illegally manufactured or distributed; where the value of the medical devices illegally manufactured or distributed is less than RMB 10,000, a fine of not less than RMB 20,000 but not more than RMB 50,000 shall be imposed concurrently; where the value is RMB 10,000 or more, a fine of not less than 5 times but not more than 20 times the value shall be imposed concurrently; where the circumstances are serious, it shall order the suspension of production and business, confiscate from the legal representative, principal person in charge, the directly responsible person in charge and other responsible persons of the illegal entity the income obtained from the entity during the period of the illegal act, impose on them a fine of not less than 30% but not more than 3 times the income obtained, and prohibit them from engaging in the manufacturing and distribution activities of medical devices within 10 years.

Article 86. Under any of the following circumstances, the department responsible for drug regulation shall order rectification, and confiscate the medical devices illegally manufactured, distributed or used; where the value of the medical devices illegally manufactured, distributed or used is less than RMB 10,000, a fine of not less than RMB 20,000 but not more than RMB 50,000 shall be imposed concurrently; where the value is RMB 10,000 or more, a fine of not less than 5 times but not more than 20 times the value shall be imposed concurrently; where the circumstances are serious, it shall order the suspension of production and business, up to the revocation by the original certificate-issuing department of the medical device registration certificate, medical device manufacturing license, or medical device distribution license, confiscate from the legal representative, principal person in charge, the directly responsible person in charge and other responsible persons of the illegal entity the income obtained from the entity during the period of the illegal act, impose on them a fine of not less than 30% but not more than 3 times the income obtained, and prohibit them from engaging in the manufacturing and distribution activities of medical devices within 10 years:

(I) manufacturing, distributing or using medical devices that do not comply with the mandatory standards or do not comply with the registered or filed product technical requirements;

(II) failing to organize manufacture in accordance with the registered or filed product technical requirements, or failing to establish a quality management system and keep it in effective operation in accordance with the provisions of this Regulation, thereby affecting the safety and effectiveness of the product;

(III) distributing or using medical devices without certification documents of conformity, or that are expired, ineffective or obsolete, or using medical devices that have not been registered in accordance with the law;

(IV) refusing to recall after being ordered to recall by the department responsible for drug regulation, or refusing to stop manufacture, importation or distribution of medical devices after being ordered to stop or suspend manufacture, importation or distribution by the department responsible for drug regulation;

(V) entrusting an enterprise that does not possess the conditions prescribed in this Regulation to manufacture medical devices, or failing to manage the manufacturing conduct of the entrusted manufacturing enterprise;

(VI) importing expired, ineffective, obsolete and other used medical devices.

Article 87. Where a medical device distribution enterprise or use entity has performed the incoming inspection and other obligations prescribed in this Regulation, has sufficient evidence to prove that it did not know that the medical devices it distributed or used were medical devices in the circumstances prescribed in item (I) of the first paragraph of Article 81, item (I) of Article 84, and items (I) and (III) of Article 86 of this Regulation, and can truthfully explain the source of its incoming goods, the medical devices it distributed or used that do not meet statutory requirements shall be confiscated, and the administrative punishment may be exempted.

Article 88. Under any of the following circumstances, the department responsible for drug regulation shall order rectification, and impose a fine of not less than RMB 10,000 but not more than RMB 50,000; where rectification is refused, a fine of not less than RMB 50,000 but not more than RMB 100,000 shall be imposed; where the circumstances are serious, it shall order the suspension of production and business, up to the revocation by the original certificate-issuing department of the medical device manufacturing license or medical device distribution license, confiscate from the legal representative, principal person in charge, the directly responsible person in charge and other responsible persons of the illegal entity the income obtained from the entity during the period of the illegal act, impose on them a fine of not less than 30% but not more than 2 times the income obtained, and prohibit them from engaging in the manufacturing and distribution activities of medical devices within 5 years:

(I) the manufacturing conditions change and no longer comply with the requirements of the medical device quality management system, and rectification, cessation of manufacture, or reporting is not carried out in accordance with the provisions of this Regulation;

(II) manufacturing or distributing medical devices whose instructions for use or labels do not comply with the provisions of this Regulation;

(III) failing to transport or store medical devices in accordance with the requirements indicated in the medical device instructions for use and labels;

(IV) transferring medical devices in use that are expired, ineffective, obsolete, or that fail inspection.

Article 89. Under any of the following circumstances, the department responsible for drug regulation and the competent health department shall, in accordance with their respective responsibilities, order rectification and give a warning; where rectification is refused, a fine of not less than RMB 10,000 but not more than RMB 100,000 shall be imposed; where the circumstances are serious, it shall order the suspension of production and business, up to the revocation by the original certificate-issuing department of the medical device registration certificate, medical device manufacturing license, or medical device distribution license, and impose a fine of not less than RMB 10,000 but not more than RMB 30,000 on the legal representative, principal person in charge, the directly responsible person in charge and other responsible persons of the illegal entity:

(I) failing to submit a self-inspection report of the quality management system as required;

(II) purchasing medical devices from a supplier without lawful qualifications;

(III) the medical device distribution enterprise or use entity failing to establish and implement the medical device incoming inspection record system in accordance with the provisions of this Regulation;

(IV) a distribution enterprise engaged in the wholesale business of Class II and Class III medical devices and the retail business of Class III medical devices failing to establish and implement the sales record system in accordance with the provisions of this Regulation;

(V) the medical device registrant, filing person, manufacturing or distribution enterprise, or use entity failing to carry out medical device adverse-event monitoring in accordance with the provisions of this Regulation, failing to report adverse events as required, or refusing to cooperate with the adverse-event investigations conducted by the medical device adverse-event monitoring technical institution, the department responsible for drug regulation, or the competent health department;

(VI) the medical device registrant or filing person failing to formulate post-market research and risk control plans and ensure their effective implementation in accordance with provisions;

(VII) the medical device registrant or filing person failing to establish and implement the product traceability system in accordance with provisions;

(VIII) the medical device registrant, filing person, or distribution enterprise engaged in the online sale of medical devices failing to notify the department responsible for drug regulation in accordance with provisions;

(IX) for medical devices that require periodic inspection, testing, calibration, care and maintenance, the medical device use entity failing to conduct inspection, testing, calibration, care and maintenance in accordance with the requirements of the product instructions for use and keep records, and to promptly conduct analysis and assessment to ensure that the medical devices are in good condition;

(X) the medical device use entity failing to properly preserve the original materials for the purchase of Class III medical devices.

Article 90. Under any of the following circumstances, the competent health department of the people’s government at or above the county level shall order rectification and give a warning; where rectification is refused, a fine of not less than RMB 50,000 but not more than RMB 100,000 shall be imposed; where the circumstances are serious, a fine of not less than RMB 100,000 but not more than RMB 300,000 shall be imposed, the relevant medical device use activities shall be ordered to be suspended, up to the revocation by the original certificate-issuing department of the practice license, the relevant responsible personnel shall be ordered in accordance with the law to suspend their practice activities for not less than 6 months but not more than 1 year, up to the revocation by the original certificate-issuing department of the practice certificates of the relevant personnel, the income obtained from the entity during the period of the illegal act shall be confiscated from the legal representative, principal person in charge, the directly responsible person in charge and other responsible persons of the illegal entity, a fine of not less than 30% but not more than 3 times the income obtained shall be imposed on them, and sanctions shall be given in accordance with the law:

(I) for reusable medical devices, the medical device use entity failing to handle them in accordance with the provisions on disinfection and management;

(II) the medical device use entity reusing single-use medical devices, or failing to destroy used single-use medical devices in accordance with provisions;

(III) the medical device use entity failing to record the information of large medical devices as well as implantable and interventional medical devices in the medical records and other relevant records in accordance with provisions;

(IV) the medical device use entity failing to immediately stop using and notify for repair upon discovering that a medical device in use poses a safety hazard, or continuing to use a medical device that still fails to meet the safety standards for use after repair;

(V) the medical device use entity using large medical equipment irregularly, failing to safeguard the quality and safety of medical care.

Article 91. Where medical devices are imported in violation of relevant laws and administrative regulations on the inspection of import and export commodities, the entry-exit inspection and quarantine institution shall handle it in accordance with the law.

Article 92. Where an e-commerce platform operator that provides services for the online trading of medical devices, in violation of the provisions of this Regulation, fails to perform management obligations such as conducting real-name registration of the medical device operators that join the platform, reviewing their licensing, registration and filing status, stopping and reporting illegal acts, and stopping the provision of online trading platform services, the department responsible for drug regulation shall impose punishment in accordance with the provisions of the E-Commerce Law of the People’s Republic of China.

Article 93. Where a clinical trial is conducted without filing the medical device clinical trial institution, the department responsible for drug regulation shall order the cessation of the clinical trial and rectification; where rectification is refused, the clinical trial data shall not be used for product registration or filing, a fine of not less than RMB 50,000 but not more than RMB 100,000 shall be imposed, and a public announcement shall be made to the public; where serious consequences are caused, it shall be prohibited from conducting clinical trials of medical devices in the relevant specialty within 5 years, a fine of not less than RMB 100,000 but not more than RMB 300,000 shall be imposed, and the competent health department shall confiscate from the legal representative, principal person in charge, the directly responsible person in charge and other responsible persons of the illegal entity the income obtained from the entity during the period of the illegal act, impose on them a fine of not less than 30% but not more than 3 times the income obtained, and give sanctions in accordance with the law.

Where the sponsor of a clinical trial conducts a clinical trial without filing, the department responsible for drug regulation shall order the cessation of the clinical trial, impose a fine of not less than RMB 50,000 but not more than RMB 100,000 on the sponsor of the clinical trial, and make a public announcement to the public; where serious consequences are caused, a fine of not less than RMB 100,000 but not more than RMB 300,000 shall be imposed. The clinical trial data shall not be used for product registration or filing, and the medical device registration applications filed by the relevant responsible persons and entities shall not be accepted within 5 years.

Where the sponsor of a clinical trial conducts a clinical trial of a Class III medical device that poses a relatively high risk to the human body without approval, the department responsible for drug regulation shall order the immediate cessation of the clinical trial, impose a fine of not less than RMB 100,000 but not more than RMB 300,000 on the sponsor of the clinical trial, and make a public announcement to the public; where serious consequences are caused, a fine of not less than RMB 300,000 but not more than RMB 1,000,000 shall be imposed. The clinical trial data shall not be used for product registration, the medical device clinical trial and registration applications filed by the relevant responsible persons and entities shall not be accepted within 10 years, the income obtained from the entity during the period of the illegal act shall be confiscated from the legal representative, principal person in charge, the directly responsible person in charge and other responsible persons of the illegal entity, and a fine of not less than 30% but not more than 3 times the income obtained shall be imposed on them.

Article 94. Where a medical device clinical trial institution conducts a medical device clinical trial without complying with the good clinical practice for clinical trials, the department responsible for drug regulation shall order rectification or the immediate cessation of the clinical trial, and impose a fine of not less than RMB 50,000 but not more than RMB 100,000; where serious consequences are caused, it shall be prohibited from conducting clinical trials of medical devices in the relevant specialty within 5 years, and the competent health department shall confiscate from the legal representative, principal person in charge, the directly responsible person in charge and other responsible persons of the illegal entity the income obtained from the entity during the period of the illegal act, impose on them a fine of not less than 30% but not more than 3 times the income obtained, and give sanctions in accordance with the law.

Article 95. Where a medical device clinical trial institution issues a false report, the department responsible for drug regulation shall impose a fine of not less than RMB 100,000 but not more than RMB 300,000; where there are illegal gains, the illegal gains shall be confiscated; it shall be prohibited from conducting clinical trials of medical devices in the relevant specialty within 10 years; and the competent health department shall confiscate from the legal representative, principal person in charge, the directly responsible person in charge and other responsible persons of the illegal entity the income obtained from the entity during the period of the illegal act, impose on them a fine of not less than 30% but not more than 3 times the income obtained, and give sanctions in accordance with the law.

Article 96. Where a medical device inspection institution issues a false inspection report, the competent department that granted its qualification shall revoke its inspection qualification, shall not accept the qualification accreditation applications filed by the relevant responsible persons and entities within 10 years, and shall impose a fine of not less than RMB 100,000 but not more than RMB 300,000; where there are illegal gains, the illegal gains shall be confiscated; the income obtained from the entity during the period of the illegal act shall be confiscated from the legal representative, principal person in charge, the directly responsible person in charge and other responsible persons of the illegal entity, a fine of not less than 30% but not more than 3 times the income obtained shall be imposed on them, and sanctions shall be given in accordance with the law; those who are dismissed shall be prohibited from engaging in medical device inspection work within 10 years.

Article 97. Where the provisions of this Regulation on the administration of medical device advertisements are violated, punishment shall be imposed in accordance with the provisions of the Advertising Law of the People’s Republic of China.

Article 98. Where an enterprise legal person within China designated by an overseas medical device registrant or filing person fails to perform the relevant obligations in accordance with the provisions of this Regulation, the drug regulatory department of the people’s government of the province, autonomous region or municipality directly under the Central Government shall order rectification, give a warning, and impose a fine of not less than RMB 50,000 but not more than RMB 100,000; where the circumstances are serious, a fine of not less than RMB 100,000 but not more than RMB 500,000 shall be imposed, and its legal representative, principal person in charge, the directly responsible person in charge and other responsible persons shall be prohibited from engaging in the manufacturing and distribution activities of medical devices within 5 years.

Where an overseas medical device registrant or filing person refuses to perform an administrative punishment decision made in accordance with this Regulation, its medical devices shall be prohibited from importation within 10 years.

Article 99. Where a medical device research, manufacturing or distribution entity or inspection institution, in violation of the provisions of this Regulation, uses personnel prohibited from engaging in the manufacturing and distribution activities of medical devices or in inspection work, the department responsible for drug regulation shall order rectification and give a warning; where rectification is refused, it shall order the suspension of production and business, up to the revocation of the licensing certificate.

Article 100. Where a medical device technical review institution or a medical device adverse-event monitoring technical institution fails to perform its duties in accordance with the provisions of this Regulation, resulting in major errors in the review or monitoring work, the department responsible for drug regulation shall order rectification, circulate a notice of criticism, and give a warning; where serious consequences are caused, the legal representative, principal person in charge, the directly responsible person in charge and other responsible persons of the illegal entity shall be given sanctions in accordance with the law.

Article 101. Where staff of the department responsible for drug regulation or other relevant departments, in violation of the provisions of this Regulation, abuse their powers, neglect their duties, or engage in malpractices for personal gain, they shall be given sanctions in accordance with the law.

Article 102. Where a violation of the provisions of this Regulation constitutes a crime, criminal liability shall be pursued in accordance with the law; where personal injury, property damage or other damage is caused, liability for compensation shall be borne in accordance with the law.

Chapter 8 Supplementary Provisions

Article 103. The meanings of the following terms in this Regulation:

A medical device refers to an instrument, apparatus, appliance, in vitro diagnostic reagent and calibrator, material, and other similar or related article used directly or indirectly on the human body, including the necessary computer software; its efficacy is mainly obtained by physical and other means, rather than by pharmacological, immunological or metabolic means, or even if such means participate, they only play an auxiliary role; and its purpose is:

(I) the diagnosis, prevention, monitoring, treatment or alleviation of disease;

(II) the diagnosis, monitoring, treatment, alleviation or functional compensation of injury;

(III) the inspection, replacement, regulation or support of a physiological structure or physiological process;

(IV) the support or sustaining of life;

(V) the control of pregnancy;

(VI) the provision of information for medical or diagnostic purposes by means of examining samples from the human body.

A medical device registrant or filing person refers to an enterprise or research institution that has obtained a medical device registration certificate or handled medical device filing.

A medical device use entity refers to an institution that uses medical devices to provide medical and other technical services to others, including medical institutions, blood stations, single-donor plasmapheresis stations, rehabilitation assistive device fitting institutions and the like.

Large medical equipment refers to large medical devices that use complex technology, involve a large amount of capital investment, have high operating costs, have a significant impact on medical expenses, and are subject to catalogue administration.

Article 104. Fees may be charged for the registration of medical device products. The specific fee items and standards shall be formulated separately by the finance and price departments of the State Council in accordance with relevant State provisions.

Article 105. The administrative measures for medical devices developed by medical and health institutions in response to public health emergencies shall be formulated by the drug regulatory department of the State Council in conjunction with the competent health department of the State Council.

Engaging in the storage, allocation and supply of non-profit contraceptive medical devices shall comply with the administrative measures formulated by the competent health department of the State Council in conjunction with the drug regulatory department of the State Council.

The technical guiding principles for traditional Chinese medicine medical devices shall be formulated by the drug regulatory department of the State Council in conjunction with the competent department of traditional Chinese medicine of the State Council.

Article 106. The supervision and administration of the use of medical devices by the military shall be carried out in accordance with this Regulation and relevant military provisions.

Article 107. This Regulation shall come into force on June 1, 2021.