Promulgated by: China Food and Drug Administration (CFDA). Order No. 18 of the China Food and Drug Administration. The Measures for the Supervision and Administration of the Quality of Medical Device Use, having been deliberated and adopted at the executive meeting of the China Food and Drug Administration on September 29, 2015, are hereby promulgated and shall come into force on February 1, 2016.
Commissioner: Bi Jingquan October 21, 2015
Chapter 1 General Provisions
Article 1. These Measures are formulated in accordance with the Regulation on the Supervision and Administration of Medical Devices in order to strengthen the supervision and administration of the quality of medical device use and to ensure the safe and effective use of medical devices.
Article 2. The quality management of medical devices at the point of use, and the supervision and administration thereof, shall comply with these Measures.
Article 3. The China Food and Drug Administration shall be responsible for the supervision and administration of the quality of medical device use throughout the country. The food and drug administration departments of local people’s governments at or above the county level shall be responsible for the supervision and administration of the quality of medical device use within their respective administrative regions.
The higher-level food and drug administration departments shall be responsible for guiding and supervising the lower-level food and drug administration departments in carrying out the supervision and administration of the quality of medical device use.
Article 4. Medical device using entities shall, in accordance with these Measures, set up a medical device quality management institution or quality management personnel commensurate with their scale, establish a use-quality management system covering the entire process of quality management, and assume responsibility for the quality management of the medical devices used by the entity.
Medical device using entities are encouraged to adopt informatized technological means to carry out medical device quality management.
Article 5. The medical devices sold by medical device manufacturing and distribution enterprises shall conform to the mandatory standards as well as the product technical requirements that have been registered or filed. Medical device manufacturing and distribution enterprises shall, in accordance with their contracts with medical device using entities, provide after-sales service for medical devices and guide and cooperate with medical device using entities in carrying out quality management.
Article 6. Where a medical device using entity discovers that an adverse event or a suspected adverse event has occurred with respect to a medical device it uses, it shall report and handle the matter in accordance with the relevant provisions on medical device adverse event monitoring.
Chapter 2 Procurement, Acceptance and Storage
Article 7. Medical device using entities shall implement unified management of medical device procurement, with the department or personnel designated by the entity uniformly procuring medical devices; other departments or personnel shall not procure medical devices on their own.
Article 8. Medical device using entities shall purchase medical devices from qualified medical device manufacturing and distribution enterprises, and shall request and verify supporting documents such as the qualifications of the supplier and the medical device registration certificate or filing voucher. The using entity shall verify the product conformity certification documents of the purchased medical devices and conduct acceptance inspection as prescribed. For medical devices with special storage and transport requirements, it shall also verify whether the storage and transport conditions meet the requirements indicated in the product instructions and labels.
Article 9. Medical device using entities shall record the incoming-inspection situation truthfully, completely and accurately. The incoming-inspection records shall be retained until two years after the expiry of the prescribed service life of the medical device or two years after the cessation of its use. The incoming-inspection records of large medical devices shall be retained until five years after the expiry of the prescribed service life of the medical device or five years after the cessation of its use; the incoming-inspection records of implantable medical devices shall be retained permanently.
Medical device using entities shall properly preserve the original materials of purchased Class III medical devices to ensure that the information is traceable.
Article 10. The premises, facilities and conditions in which a medical device using entity stores medical devices shall be commensurate with the variety and quantity of the medical devices, and shall meet the requirements indicated in the product instructions and labels and the needs of safe and effective use; where there are special requirements for environmental conditions such as temperature and humidity, the entity shall also monitor and record data such as the temperature and humidity of the storage area.
Article 11. Medical device using entities shall conduct regular inspections of the medical devices in storage and keep records in accordance with requirements such as storage conditions and the validity period of the medical devices.
Article 12. Medical device using entities shall not purchase or use medical devices that have not been registered or filed in accordance with the law, that lack conformity certification documents, or that are expired, invalid or obsolete.
Chapter 3 Use, Maintenance and Transfer
Article 13. Medical device using entities shall establish a pre-use quality inspection system for medical devices. Before using a medical device, they shall conduct inspections in accordance with the relevant requirements of the product instructions.
Before using a sterile medical device, the packaging that is in direct contact with the medical device and its validity period shall be inspected. Where the packaging is damaged, the markings are unclear, the validity period has expired, or the safety and effectiveness of use may be affected, the device shall not be used.
Article 14. Medical device using entities shall establish usage records for implantable and interventional medical devices. The usage records of implantable medical devices shall be retained permanently, and the relevant materials shall be incorporated into an informatized management system to ensure that the information is traceable.
Article 15. Medical device using entities shall establish a maintenance and repair management system for medical devices. For medical devices that require periodic inspection, testing, calibration, upkeep and maintenance, they shall conduct inspection, testing, calibration, upkeep and maintenance in accordance with the requirements of the product instructions and keep records, and shall promptly analyze and assess the same to ensure that the medical devices are in good condition.
For large medical devices with a long service life, a usage file shall be established for each unit, recording its use, maintenance and other circumstances. The retention period of the records shall not be less than five years after the expiry of the prescribed service life of the medical device or five years after the cessation of its use.
Article 16. Medical device using entities shall use medical devices in accordance with the product instructions and other requirements. Single-use medical devices shall not be reused; those that have been used shall be destroyed in accordance with the relevant provisions of the State and recorded.
Article 17. Medical device using entities may, in accordance with the contractual stipulations, require medical device manufacturing and distribution enterprises to provide maintenance and repair services for medical devices, may entrust repair service institutions with the requisite conditions and capabilities to maintain and repair medical devices, or may maintain and repair the medical devices in use on their own.
Where a medical device using entity entrusts a repair service institution or maintains and repairs the medical devices in use on its own, the medical device manufacturing or distribution enterprise shall, in accordance with the contractual stipulations, provide the materials and information necessary for maintenance and repair, such as the maintenance manual, repair manual, software backup, fault code table, spare parts list, components, and repair passwords.
Article 18. Where a medical device manufacturing or distribution enterprise or a repair service institution maintains and repairs a medical device, relevant matters such as clear quality requirements and repair requirements shall be stipulated in the contract, and the medical device using entity shall request and preserve the relevant records after each maintenance or repair; where a medical device using entity maintains and repairs medical devices on its own, it shall strengthen the training and assessment of the technical personnel engaged in medical device maintenance and repair, and establish training files.
Article 19. Where a medical device using entity discovers that a medical device in use poses a safety hazard, it shall immediately cease use and notify for repair; where repair still fails to meet the safety standards for use, the device shall not continue to be used, and shall be disposed of in accordance with the relevant provisions.
Article 20. Where medical device using entities transfer in-use medical devices between one another, the transferring party shall ensure that the transferred medical device is safe and effective and shall provide lawful product certification documents.
The parties to the transfer shall conclude an agreement, hand over materials such as the product instructions and copies of the use and repair record files, and may only transfer the device after it has passed inspection by a qualified inspection institution. The transferee shall conduct verification by reference to the provisions on incoming inspection in Article 8 of these Measures, and may only use the device after it meets the requirements.
Medical devices that have not been registered or filed in accordance with the law, that lack conformity certification documents or have failed inspection, or that are expired, invalid or obsolete, shall not be transferred.
Article 21. Where a medical device using entity accepts a donation of medical devices from a medical device manufacturing or distribution enterprise or from another institution or individual, the donor shall provide the relevant lawful certification documents of the medical devices, and the donee shall conduct verification by reference to the provisions on incoming inspection in Article 8 of these Measures, and may only use the devices after they meet the requirements.
Medical devices that have not been registered or filed in accordance with the law, that lack conformity certification documents or have failed inspection, or that are expired, invalid or obsolete, shall not be donated.
Where in-use medical devices are donated between medical device using entities, the matter shall be handled by reference to the provisions of Article 20 of these Measures on the transfer of in-use medical devices.
Chapter 4 Supervision and Administration
Article 22. The food and drug administration departments shall, in accordance with the principle of risk management, supervise and administer the quality of medical devices at the point of use.
The food and drug administration departments of districted cities shall formulate and implement annual supervision and inspection plans for the medical device using entities within their respective administrative regions, and determine the priorities, frequency and coverage of supervision and inspection. Key supervision shall be implemented with respect to medical devices that pose relatively high risks, medical devices with special storage and transport requirements, and medical device using entities with adverse credit records, among others.
The annual supervision and inspection plans and their implementation shall be reported to the food and drug administration departments of the provinces, autonomous regions and municipalities directly under the Central Government.
Article 23. When the food and drug administration departments conduct supervision and inspection of the establishment and implementation of the medical device use-quality management system by medical device using entities, they shall record the results of the supervision and inspection and incorporate them into the supervision and administration files.
When the food and drug administration departments conduct supervision and inspection of a medical device using entity, they may conduct extended inspections of the relevant medical device manufacturing and distribution enterprises, repair service institutions and the like.
Medical device using entities, manufacturing and distribution enterprises, repair service institutions and the like shall cooperate with the supervision and inspection of the food and drug administration departments, truthfully provide the relevant information and materials, and shall not refuse or conceal anything.
Article 24. Medical device using entities shall, in accordance with these Measures and the medical device use-quality management system established by the entity, conduct a comprehensive self-inspection of the medical device quality management work each year and produce a self-inspection report. The food and drug administration departments shall conduct spot checks of the self-inspection reports of medical device using entities during supervision and inspection.
Article 25. The food and drug administration departments shall strengthen sampling inspection of medical devices at the point of use. The food and drug administration departments at or above the provincial level shall, based on the conclusions of the sampling inspection, promptly issue medical device quality bulletins.
Article 26. Where any individual or organization discovers that a medical device using entity has committed an act in violation of these Measures, they shall have the right to report it to the food and drug administration department of the place where the medical device using entity is located. The food and drug administration department that receives the report shall promptly verify and handle it. Where the report is verified to be true, a reward shall be given to the informant in accordance with the relevant provisions.
Chapter 5 Legal Liability
Article 27. Where a medical device using entity falls under any of the following circumstances, the food and drug administration department at or above the county level shall impose a penalty in accordance with the provisions of Article 66 of the Regulation on the Supervision and Administration of Medical Devices:
(I) using a medical device that does not conform to the mandatory standards or does not conform to the registered or filed product technical requirements;
(II) using a medical device that lacks conformity certification documents, or that is expired, invalid or obsolete, or using a medical device that has not been registered in accordance with the law.
Article 28. Where a medical device using entity falls under any of the following circumstances, the food and drug administration department at or above the county level shall impose a penalty in accordance with the provisions of Article 67 of the Regulation on the Supervision and Administration of Medical Devices:
(I) failing to store medical devices in accordance with the requirements indicated in the product instructions and labels of the medical devices;
(II) transferring or donating in-use medical devices that are expired, invalid, obsolete or have failed inspection.
Article 29. Where a medical device using entity falls under any of the following circumstances, the food and drug administration department at or above the county level shall impose a penalty in accordance with the provisions of Article 68 of the Regulation on the Supervision and Administration of Medical Devices:
(I) failing to establish and implement a medical device incoming-inspection system, failing to verify the qualifications of the supplier, or failing to record the incoming-inspection situation truthfully, completely and accurately;
(II) failing to conduct periodic inspection, testing, calibration, upkeep and maintenance in accordance with the requirements of the product instructions and keep records;
(III) failing to immediately cease use 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;
(IV) failing to properly preserve the original materials of purchased Class III medical devices;
(V) failing to establish and preserve usage records for implantable and interventional medical devices as prescribed.
Article 30. Where a medical device using entity falls under any of the following circumstances, the food and drug administration department at or above the county level shall order corrections within a time limit and give a warning; where corrections are refused, a fine of not more than RMB 10,000 shall be imposed:
(I) failing to set up, as prescribed, a medical device quality management institution or quality management personnel commensurate with its scale, or failing to establish, as prescribed, a use-quality management system covering the entire process of quality management;
(II) failing to have a designated department or personnel uniformly procure medical devices as prescribed;
(III) purchasing or using Class I medical devices that have not been filed, or purchasing Class II medical devices from a distribution enterprise that has not been filed;
(IV) where the premises, facilities and conditions for storing medical devices are not commensurate with the variety and quantity of the medical devices, or failing to conduct regular inspections of the medical devices in storage and keep records in accordance with requirements such as storage conditions and the validity period of the medical devices;
(V) failing to establish and implement a pre-use quality inspection system for medical devices as prescribed;
(VI) failing to request and preserve the records relating to medical device maintenance and repair as prescribed;
(VII) failing to conduct training and assessment of the relevant technical personnel of the entity engaged in medical device maintenance and repair, and to establish training files, as prescribed;
(VIII) failing to conduct self-inspection of its medical device quality management work and produce a self-inspection report as prescribed.
Article 31. Where a medical device manufacturing or distribution enterprise, in violation of the provisions of Article 17 of these Measures, fails to provide maintenance and repair services as required, or fails to provide the materials and information necessary for maintenance and repair as required, the food and drug administration department at or above the county level shall give a warning and order corrections within a time limit; where the circumstances are serious or corrections are refused, a fine of not less than RMB 5,000 but not more than RMB 20,000 shall be imposed.
Article 32. Where a medical device using entity, manufacturing or distribution enterprise, repair service institution or the like fails to cooperate with the supervision and inspection of the food and drug administration department, or refuses, conceals or fails to truthfully provide the relevant information and materials, the food and drug administration department at or above the county level shall order corrections, give a warning, and may concurrently impose a fine of not more than RMB 20,000.
Chapter 6 Supplementary Provisions
Article 33. The quality management of investigational medical devices used for clinical trials shall be carried out in accordance with the relevant provisions on medical device clinical trials.
Article 34. The supervision and administration of the use of medical devices at the point of use shall be carried out in accordance with the relevant provisions of the National Health and Family Planning Commission.
Article 35. These Measures shall come into force on February 1, 2016.