Promulgated by: National Health Commission and National Medical Products Administration. Document No.: Guo Wei Gui Hua Fa [2018] No. 12. Issued and effective: 22 May 2018.
To the health and family planning commissions and food-and-drug administrations of all provinces, autonomous regions and municipalities directly under the Central Government and the Xinjiang Production and Construction Corps:
Pursuant to the Decision of the State Council on Amending the Regulation on the Supervision and Administration of Medical Devices (State Council Order No. 680), and in order to standardize and strengthen the configuration and use management of large medical equipment, the Measures for the Administration of the Configuration and Use of Large Medical Equipment (Trial) have been formulated (and may be downloaded from the official website of the National Health Commission). They are hereby issued to you. Please implement them accordingly.
National Health Commission · National Medical Products Administration 22 May 2018
Chapter 1 General Provisions
Article 1. In order to deepen the streamlining of administration and delegation of powers, the combination of decentralization and regulation, and the optimization of services; to promote the rational configuration and effective use of large medical equipment; to safeguard the quality and safety of medical care; to control the excessively rapid growth of medical costs; and to protect the health rights and interests of the people, these Measures are formulated in accordance with the Administrative Licensing Law, the Decision of the State Council on Amending the Regulation on the Supervision and Administration of Medical Devices, and other laws and regulations.
Article 2. “Large medical equipment” as used in these Measures refers to large medical devices that are technically complex to use, require large capital investment, have high operating costs, have a significant impact on medical costs, and are included in catalogue management.
Article 3. The catalogue of large medical equipment shall be proposed by the National Health Commission in consultation with the relevant departments of the State Council, and shall be promulgated and implemented after being submitted to and approved by the State Council.
Article 4. The State shall implement, in accordance with the catalogue, hierarchical and classified configuration planning and configuration-licence management for large medical equipment.
Article 5. The National Health Commission shall be responsible for formulating and organizing the implementation of the management systems for the configuration and use of large medical equipment, and shall guide the evaluation and supervision of configuration and use conduct. Local health administrative departments at or above the county level shall be responsible for the supervision and administration of configuration and use conduct for large medical equipment within their respective regions.
Article 6. The National Health Commission shall establish an expert advisory committee on large-medical-equipment management to provide technical support — including review, consultation and feasibility assessment — for determining and adjusting the management catalogue, formulating and implementing configuration plans, and managing the whole process of configuration and use.
Provincial-level health administrative departments may establish corresponding expert groups.
Article 7. These Measures shall apply where a medical-device user unit configures and uses large medical equipment for the provision of medical services.
Chapter 2 Management Catalogue
Article 8. The National Health Commission shall, in light of medical-service demand and the state of medical-device development, and taking into account factors such as capital investment, operating and usage costs, and technical requirements, propose recommendations for the large-medical-equipment configuration-management catalogue.
Article 9. The large-medical-equipment configuration-management catalogue is divided into Class A and Class B. Class-A large medical equipment shall be subject to configuration management by the National Health Commission, which shall issue the configuration licence; Class-B large medical equipment shall be subject to configuration management by provincial-level health administrative departments, which shall issue the configuration licence.
Article 10. The National Health Commission shall assess the safety, effectiveness, economy, and appropriateness of the use of large medical devices, and shall propose adjustments to the large-medical-equipment management catalogue in a timely manner.
Article 11. Adjustments to the large-medical-equipment management catalogue include: (I) inclusion in the management catalogue; (II) reclassification of equipment from the Class-A management catalogue to the Class-B management catalogue; (III) reclassification of equipment from the Class-B management catalogue to the Class-A management catalogue; (IV) removal from the management catalogue.
Article 12. National medical-sector industry organizations and provincial-level health administrative departments may submit to the National Health Commission recommendations to adjust the large-medical-equipment management catalogue. A medical-device user unit may submit adjustment recommendations to the provincial-level health administrative department where it is located; where, following feasibility assessment, the provincial-level health administrative department considers it genuinely necessary, it may submit an adjustment recommendation to the National Health Commission.
Where the National Health Commission considers, in the course of large-medical-equipment management, that the management catalogue needs to be adjusted, it shall promptly initiate the adjustment process.
The National Health Commission shall organize feasibility assessment of catalogue-adjustment recommendations, and on the basis of the assessment opinions shall, in consultation with the relevant departments of the State Council, submit the matter to the State Council for approval.
Chapter 3 Configuration Planning
Article 13. Configuration planning for large medical equipment shall be commensurate with the level of national economic and social development, the progress of medical science and technology, and the health needs of the people; shall conform to the planning of the medical and health service system; and shall promote the sharing of regional medical resources.
Article 14. In principle, configuration plans for large medical equipment shall be prepared once every five years and implemented on an annual basis. A configuration plan shall include the planned quantity, the annual implementation plan, the regional layout, and the configuration standards.
For the first-time configuration of a large medical device, the configuration plan shall in principle not exceed five units, of which no more than three may be produced by a single enterprise.
Configuration planning for large medical equipment shall give full consideration to the development needs of privately run medical care, and shall reasonably reserve planning capacity.
Article 15. Provincial-level health administrative departments shall, in light of the planning of their local medical and health service systems, propose recommendations for local large-medical-equipment configuration plans and implementation schemes and submit them to the National Health Commission. The National Health Commission shall be responsible for formulating the large-medical-equipment configuration plan and shall make it public.
Article 16. Health administrative departments at or above the provincial level shall conduct evaluation and assessment of the implementation of large-medical-equipment configuration plans, and shall establish and improve a third-party supervision and evaluation mechanism.
Article 17. Where a large-medical-equipment configuration plan clearly fails to adapt to national economic and social development, the progress of medical science and technology, and the health needs of the people, or where the planning of the medical and health service system undergoes major adjustment, the National Health Commission shall adjust the large-medical-equipment configuration plan.
Provincial-level health administrative departments may propose recommendations to adjust the configuration plan for their respective regions.
Article 18. The National Health Commission shall organize the formulation and release of a tiered classification of large-medical-equipment model grades. A medical-device user unit shall, in light of its functional positioning, clinical-service needs, medical-technology level, and specialty development, reasonably select the appropriate grade and model of large medical equipment.
Chapter 4 Configuration Management
Article 19. Where a medical-device user unit applies to configure large medical equipment, it shall conform to the large-medical-equipment configuration plan, be commensurate with its functional positioning and clinical-service needs, and possess the corresponding technical conditions, supporting facilities, and professional technical personnel with the requisite qualifications and capabilities.
An application to configure Class-A large medical equipment shall be submitted to the National Health Commission; an application to configure Class-B large medical equipment shall be submitted to the provincial-level health administrative department where the unit is located.
Article 20. A medical-device user unit applying to configure large medical equipment shall truthfully and accurately submit the following materials: (I) the large-medical-equipment configuration application form; (II) a copy of the medical-device user unit’s practising licence (or a copy of the medical-device user unit’s establishment approval document, or a copy of other legal-person qualification certificates for the provision of medical services that meet the relevant requirements); (III) a copy of the unified social credit code certificate (or organization-code certificate); (IV) materials evidencing the technical conditions, supporting facilities, and the qualifications and capabilities of the professional technical personnel corresponding to the large medical equipment applied for.
Article 21. The health administrative department that accepts a configuration application shall conduct a third-party expert review of the matters declared by the medical-device user unit, and shall make a licensing decision within 20 working days from the date of acceptance of the application.
Where expert review is required to be organized under these Measures, the time taken for expert review shall not be counted within the licensing time limit.
Article 22. The National Health Commission shall be responsible for formulating the form of the large-medical-equipment configuration licence and for the printing, issuance, and other management of the Class-A Large Medical Equipment Configuration Licence. Provincial-level health administrative departments shall be responsible for the printing, issuance, and other management of the Class-B Large Medical Equipment Configuration Licence within their respective administrative regions.
Article 23. The large-medical-equipment configuration licence shall be issued on a “one machine, one licence” basis and shall consist of an original and a duplicate. The form is set out in Attachment 1.
The original shall state: the name of the configuring unit, the legal representative or principal person in charge, the ownership type, the equipment-configuration address, the unified social credit code (or organization code), the name of the licensed equipment, the tiered configuration model, the licence number, the issuing authority, the date of issuance, and a QR code.
The duplicate shall state: the information set out in the original, together with the manufacturing enterprise of the configured equipment, the specific model, the tiered configuration model, the product serial number, the installation date, the information-reporting date, and remarks.
The date of issuance of a large-medical-equipment configuration licence shall be the date on which the licensing decision is made.
Article 24. The number of a large-medical-equipment configuration licence shall consist of the Chinese characters “甲” or “乙” (“甲” and “乙” representing Class-A and Class-B large medical equipment respectively) and a 10-digit Arabic numeral. From left to right, the digits are: a 2-digit code for the province (autonomous region or municipality directly under the Central Government), a 2-digit large-medical-equipment category code, a 1-digit tiered-classification code, and a 5-digit sequence code. The rules for licence numbering are set out in Attachment 2.
Article 25. After obtaining a large-medical-equipment configuration licence, a medical-device user unit shall promptly configure the corresponding large medical equipment and shall report to the issuing authority the relevant information on the large medical equipment so configured. The configuration time limit shall be prescribed by the issuing authority.
Where the information on a large-medical-equipment configuration licence changes, the medical-device user unit shall report to the original issuing authority within 10 working days from the date of the change. The issuing authority shall amend the relevant information within 10 working days from the date of receipt.
Article 26. A medical-device user unit shall use and properly safeguard its large-medical-equipment configuration licence in accordance with the law, and shall not forge, alter, sell, lease, or lend it.
A medical-device user unit shall list the information on its large-medical-equipment configuration licence as information to be proactively disclosed to the public, and shall display the original of the large-medical-equipment configuration licence in a prominent position at the location where the large medical equipment is used.
Article 27. In any of the following circumstances, a large-medical-equipment configuration licence shall automatically become invalid, and the medical-device user unit shall return the large-medical-equipment configuration licence to the original issuing authority within 5 working days from the date of invalidation, whereupon the original issuing authority shall cancel it: (I) the practising licence (or other legal-person qualification for the provision of medical services) of the medical-device user unit is terminated; (II) the relevant diagnosis-and-treatment subject is cancelled; (III) configuration has not been completed within the prescribed time limit without justified reason; (IV) the corresponding equipment has not been configured in accordance with the issued large-medical-equipment configuration licence; (V) other circumstances prescribed by laws and regulations.
Where the licence becomes invalid as a result of item (III) of this Article, the applicant institution and the person in charge shall be entered into the adverse-credit record.
Where a large-medical-equipment configuration licence becomes invalid but the medical-device user unit still needs to use the equipment, it shall re-apply in accordance with Articles 19 and 20 of these Measures.
Article 28. The large medical equipment configured by a medical-device user unit shall have obtained, in accordance with the law, a medical-device registration certificate or filing voucher.
Article 29. The National Health Commission and provincial-level health administrative departments shall respectively make public the configuration-licensing status of Class-A and Class-B large medical equipment.
Provincial-level health administrative departments shall, in January each year, report to the National Health Commission the configuration-licensing status of Class-B large medical equipment for the preceding year.
Chapter 5 Use Management
Article 30. The use of large medical equipment shall follow the principles of safety, effectiveness, rationality, and necessity.
Article 31. A medical-device user unit shall establish a large-medical-equipment management archive, recording matters such as the procurement, installation, acceptance, use, maintenance, repair, and quality control of the equipment, and shall truthfully record the relevant information.
Article 32. A medical-device user unit shall, in accordance with the requirements of the large-medical-equipment product manual and the like, conduct regular inspection, testing, calibration, upkeep, and maintenance, so as to ensure that the large medical equipment is in good condition. Large medical equipment may be used only after it has achieved accurate measurement (dosage), radiation-protection safety, and qualified performance indicators.
Article 33. A medical-device user unit shall, in accordance with the requirements of national laws and regulations, establish and improve information-security safeguard measures for the use of large medical equipment, so as to ensure the operational security of the relevant information systems and the security of medical data.
Article 34. Health administrative departments shall supervise and assess the use status of large medical equipment.
A medical-device user unit bears the principal responsibility for use, and shall establish and improve a large-medical-equipment use-evaluation system, strengthen assessment and analysis, promote rational application, and regularly report use status to health administrative departments at or above the county level.
Article 35. Personnel using large medical equipment shall possess the corresponding qualifications and capabilities, and shall use large medical equipment in accordance with the product manual, technical operating specifications, and the like.
Article 36. Where a medical-device user unit discovers an adverse event or suspected adverse event involving large medical equipment, it shall promptly report it to the medical-device adverse-event monitoring technical institution in accordance with the relevant provisions.
Where a medical-device user unit discovers a safety hazard in the use of large medical equipment, or where the external environment, personnel, technology, or other conditions change such that the safety and quality of use can no longer be guaranteed, it shall immediately cease use. Where the equipment cannot meet the safety standards for use after repair, it shall not continue to be used.
Article 37. A medical-device user unit shall not use large medical equipment that lacks a certificate of conformity, or that is expired, invalid, or obsolete, and shall not, in the name of upgrading or the like, increase the configuration performance or specifications of equipment without authorization so as to evade large-medical-equipment configuration management.
A medical-device user unit is strictly prohibited from introducing large medical equipment that has been developed overseas but is not yet configured and used overseas.
Chapter 6 Supervision and Administration
Article 38. The National Health Commission, relying on the large-medical-equipment configuration-and-use supervision and administration information system, shall promptly publish supervision and administration information on the configuration and use of large medical equipment, so as to facilitate public inquiry and social supervision. A medical-device user unit shall regularly and truthfully complete and report the relevant information on the configuration and use of large medical equipment.
Article 39. Health administrative departments shall conduct supervision and inspection of the following matters: (I) the implementation status of the large-medical-equipment configuration plan; (II) the holding and use status of the Large Medical Equipment Configuration Licence; (III) the use status of large medical equipment and the status of information security in its use; (IV) the staffing of personnel using large medical equipment; (V) the reporting of use status by the medical-device user unit in accordance with the provisions; (VI) other circumstances prescribed by health administrative departments at or above the provincial level.
Article 40. Supervision and inspection of the configuration and use of large medical equipment by medical-device user units shall be conducted by randomly selecting the objects of inspection and randomly assigning law-enforcement inspectors, with the spot-check situation and the handling results promptly made public. The following methods may be adopted: (I) regular inspection and irregular spot-checks; (II) consulting and copying management documents, records, archives, medical records, and other relevant materials, or requiring the provision of relevant data and materials; (III) on-site inspection, with verification testing and measurement; (IV) real-time online supervision; (V) other supervision and inspection measures prescribed by laws and regulations.
Medical-device user units and individuals shall cooperate with the relevant supervision and inspection, and shall not make false or concealed reports of relevant circumstances.
Article 41. Health administrative departments at or above the county level shall establish credit archives for units configuring and using large medical equipment and their personnel. For those with an adverse-credit record, the frequency of supervision and inspection shall be increased.
Where a medical-device user unit makes false or concealed reports of relevant circumstances in the configuration-licensing application for, or the use of, large medical equipment, the health administrative department shall report the unlawful records of the person in charge of the medical-device user unit and the directly responsible person to the relevant departments, and shall enter them into the credit archives of the relevant persons.
Article 42. The State encourages industry associations to establish and improve self-discipline mechanisms, to strengthen industry self-regulation and mutual supervision, and to promote the safe and rational use of large medical equipment.
Article 43. Where, in violation of these Measures, a health administrative department fails to report annual configuration-licensing information as required, or its large-medical-equipment management systems are inadequate or its performance of duties is not in place, the higher-level health administrative department shall circulate a notice of criticism and order rectification.
Article 44. Where, in violation of these Measures, large-medical-equipment configuration licensing is carried out in excess of the plan, beyond the scope of authority, or unlawfully, it shall be dealt with in accordance with the Administrative Licensing Law, the Regulation on the Supervision and Administration of Medical Devices, and other relevant provisions.
Article 45. Where a medical-device user unit fails to use equipment rationally in accordance with operating procedures and diagnosis-and-treatment norms, or employs personnel without the corresponding qualifications and capabilities to use large medical equipment, such that the quality and safety of medical care cannot be guaranteed, the health administrative department at or above the county level shall deal with it in accordance with the law.
Chapter 7 Supplementary Provisions
Article 46. The National Health Commission and provincial-level health administrative departments shall respectively formulate implementing rules for the configuration licensing of Class-A and Class-B large medical equipment.
Article 47. A medical-device user unit shall file with the local health administrative department at or above the county level, and publicly disclose, the technical conditions and use information of personnel using large medical devices that are within the same item category in the management catalogue but not subject to configuration licensing.
Article 48. The configuration management of large medical equipment within pilot free-trade zones approved by the State Council shall be implemented in accordance with the relevant provisions of the State.
The procurement of large medical equipment shall be implemented in accordance with the relevant provisions of the State.
Article 49. These Measures shall take effect from the date of promulgation. The Measures for the Administration of the Configuration and Use of Large Medical Equipment of the former Ministry of Health, National Development and Reform Commission, and Ministry of Finance (Wei Gui Cai Fa [2004] No. 474) and the Provisions on the Administration of the Configuration of New Large Medical Equipment of the former Ministry of Health (Wei Gui Cai Fa [2013] No. 13) shall be repealed simultaneously.
Attachments:
- Form of and Explanatory Notes on the Large Medical Equipment Configuration Licence
- Rules for Numbering the Large Medical Equipment Configuration Licence
Data-compliance note. This rule is primarily a configuration-licensing and use-management regime, not a data-protection instrument, but it has three concrete data touchpoints. (1) Configuration-and-use supervision information system — operators must register and regularly file equipment configuration and use information into the national supervision system (Articles 25, 38), and licence information is treated as proactively disclosed public information (Article 26). (2) Use and quality records / use archives — operators must maintain management archives of procurement, installation, use, maintenance and quality control (Article 31). (3) Information-security safeguards — Article 33 requires operators to build information-security safeguards for large-equipment use to ensure the operational security of the relevant information systems and the security of medical data, and Article 39(III) makes “information security in use” an express supervision item. Misreporting and certain licence lapses carry credit-archive (信用档案) consequences (Articles 27, 41). The two attachments (licence form and numbering rules) are not reproduced here.
— Measures for the Administration of the Configuration and Use of Large Medical Equipment (Trial), issued jointly on 22 May 2018 by the National Health Commission and the National Medical Products Administration (Guo Wei Gui Hua Fa [2018] No. 12). DCC translation. For the source document, see the National Health Commission website.