The latest “Measures for the Supervision and Administration of the Quality of Medical Device Use”

Chapter I General Provisions
 
Article 1: In order to strengthen the supervision and administration of the quality of medical device use and to ensure the safety and effectiveness of such devices, these Measures are hereby formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices.
 
Article 2: The quality management and supervisory administration of medical devices at the use stage shall comply with these Measures.
 
Article 3 The National Medical Products Administration is responsible for the supervision and administration of the quality of medical device use nationwide. Local food and drug administration departments at or above the county level are responsible for the supervision and administration of the quality of medical device use within their respective administrative areas.
 
The higher-level food and drug administration authority is responsible for guiding and supervising the lower-level food and drug administration authorities in carrying out quality supervision and management of medical device use.
 
Article 4 Medical device user establishments shall, in accordance with these Measures, establish a medical device quality management organization or appoint quality management personnel commensurate with their scale, formulate a usage quality management system that covers the entire quality management process, and assume responsibility for the quality management of medical devices used within their establishment.
 
Medical device users are encouraged to adopt information technology tools for medical device quality management.
 
Article 5: Medical devices sold by medical device manufacturers and operators shall comply with mandatory standards and the product technical requirements that have been registered or filed. Medical device manufacturers and operators shall, in accordance with the contractual agreements with medical device users, provide after-sales services and offer guidance and support to assist medical device users in carrying out quality management activities.
 
Article 6: When a medical device user discovers an adverse event or a suspected adverse event involving a medical device in use, it shall report and handle such events in accordance with the relevant provisions on medical device adverse event monitoring.
 
Chapter 2 Procurement, Acceptance, and Storage
 
Article 7 Medical device-using institutions shall implement unified management of medical device procurement, with designated departments or personnel responsible for centralized purchasing; no other departments or personnel may engage in independent procurement.
 
Article 8 Medical device user entities shall procure medical devices from qualified medical device manufacturers and operators, and shall request and verify the supplier’s qualifications, as well as the medical device registration certificate or filing certificate and other supporting documents. Upon receipt, they shall verify the product’s conformity documentation and conduct acceptance inspection in accordance with applicable regulations. For medical devices subject to special storage and transportation requirements, they shall also confirm that the storage and transportation conditions comply with the requirements specified in the product instructions and on the label.
 
Article 9: Medical device user establishments shall maintain truthful, complete, and accurate records of incoming inspection. Such records shall be retained for two years after the expiration of the medical device’s specified service life or two years after its use has been discontinued. For large-scale medical devices, the relevant records shall be retained for five years after the expiration of the device’s specified service life or five years after its use has been discontinued; records pertaining to implantable medical devices shall be kept permanently.
 
Medical device users shall properly retain the original records of purchases of Class III medical devices to ensure information traceability.
 
Article 10: The premises, facilities, and conditions used by medical device user establishments for storing medical devices shall be commensurate with the types and quantities of devices stored, and shall comply with the requirements set forth in the product instructions and label markings, as well as with the needs for safe and effective use. Where specific environmental conditions such as temperature and humidity are required, the temperature, humidity, and other relevant parameters of the storage area shall also be monitored and recorded.
 
Article 11: Medical device user establishments shall conduct regular inspections of stored medical devices in accordance with storage conditions, the expiration dates of the devices, and other relevant requirements, and shall maintain records thereof.
 
Article 12: Medical device user institutions shall not purchase or use medical devices that have not been legally registered or filed, lack valid certification documents, or are expired, invalidated, or obsolete.
 
Chapter 3: Use, Maintenance, and Transfer
 
Article 13: Medical device user units shall establish a pre-use quality inspection system. Prior to the use of medical devices, inspections shall be conducted in accordance with the relevant requirements set forth in the product instructions.
 
Before using sterile medical devices, the packaging in direct contact with the device and its expiration date shall be inspected. Devices with damaged packaging, unclear labeling, expired shelf life, or any condition that may compromise safety or efficacy shall not be used.
 
Article 14: Medical device-using institutions shall maintain usage records for implantable and interventional medical devices. Records for implantable medical devices shall be retained permanently, and relevant documentation shall be incorporated into an information management system to ensure traceability of information.
 
Article 15: Medical device user establishments shall establish a management system for the maintenance and repair of medical devices. For medical devices that require periodic inspection, testing, calibration, servicing, and maintenance, such activities shall be carried out in accordance with the requirements specified in the product instructions, with corresponding records kept, and timely analysis and evaluation conducted to ensure that the medical devices remain in good working condition.
 
For large medical devices with long service lives, a separate usage file shall be established for each unit, documenting its use, maintenance, and other relevant information. The retention period for such records shall be no less than five years after the expiration of the device’s prescribed service life or five years after its use has been discontinued.
 
Article 16: Medical device user institutions shall use medical devices in accordance with the product instructions and other relevant requirements. Single-use medical devices shall not be reused; used devices shall be destroyed in compliance with applicable national regulations and properly documented.
 
Article 17 Medical device user entities may, in accordance with the terms of the contract, require medical device manufacturers and operators to provide maintenance and repair services. Alternatively, they may entrust qualified and capable maintenance service providers to perform such services, or undertake the maintenance and repair of in-use medical devices themselves.
 
When a medical device user entrusts a maintenance service provider or undertakes maintenance and repair of in-use medical devices on its own, the medical device manufacturer or operator shall, in accordance with the terms of the contract, provide the necessary materials and information for maintenance and repair, including maintenance manuals, repair manuals, software backups, fault‑code tables, spare‑parts lists, component parts, and repair passwords.
 
Article 18: Where medical devices are maintained and repaired by medical device manufacturers, operators, or maintenance service providers, the relevant parties shall specify in the contract clear quality requirements, repair standards, and other pertinent matters. Medical device users shall obtain and retain the corresponding records after each maintenance or repair operation. If medical device users undertake maintenance and repair themselves, they shall strengthen training and assessment of the technical personnel engaged in such activities and establish training records.
 
Article 19: When a medical device user discovers a safety hazard in a medical device in use, it shall immediately cease its use and notify the maintenance department for inspection and repair. If, after such inspection and repair, the device still fails to meet the required safety standards, it shall not be further used and shall be disposed of in accordance with relevant regulations.
 
Article 20: When a medical device user transfers an in-use medical device to another entity, the transferring party shall ensure that the transferred medical device is safe and effective and shall provide valid documentation demonstrating the product’s legal compliance.
 
The transferring parties shall enter into an agreement, hand over relevant documents such as copies of the product instruction manual and records of use and maintenance, and may proceed with the transfer only after passing inspection by a qualified testing institution. The transferee shall conduct inspections in accordance with the provisions on incoming goods verification set forth in Article 8 of these Measures and may put the items into use only upon compliance with the requirements.
 
Medical devices that have not been legally registered or filed, lack valid certification documents, have failed inspection, or are expired, invalidated, or obsolete shall not be transferred.
 
Article 21: When a medical device user unit accepts donated medical devices from medical device manufacturers, operators, or other organizations or individuals, the donor shall provide the relevant legal documentation for the medical devices. The recipient shall conduct inspection in accordance with the provisions on incoming goods verification set forth in Article 8 of these Measures and may only put the devices into use upon confirmation of compliance.
 
It is prohibited to donate medical devices that have not been legally registered or filed, lack valid certification documents or have failed inspection, as well as those that are expired, invalidated, or obsolete.
 
When medical device user institutions donate in-use medical devices to one another, the procedures shall be carried out in accordance with Article 20 of these Measures, which governs the transfer of in-use medical devices.
 
Chapter Four: Supervision and Management
 
Article 22: The food and drug administration authorities shall, in accordance with the principles of risk management, exercise supervision and administration over the quality of medical devices at the point of use.
 
The food and drug administration department at the prefecture-level city shall formulate and implement an annual supervisory inspection plan for medical device use units within its administrative area, specifying the priorities, frequency, and coverage of such inspections. Medical device use units handling high-risk devices, devices with special storage and transportation requirements, or those with adverse credit records shall be subject to enhanced regulatory oversight.
 
The annual supervision and inspection plan and its implementation shall be reported to the food and drug administration authorities of the province, autonomous region, or municipality directly under the central government.
 
Article 23: The food and drug administration authorities shall conduct supervisory inspections of medical device use units to assess their establishment and implementation of quality management systems for the use of medical devices, record the results of such inspections, and include them in the supervisory management archives.
 
When conducting supervisory inspections of medical device users, the food and drug administration authorities may extend their investigations to relevant medical device manufacturers, distributors, and maintenance service providers.
 
Medical device users, manufacturers and operators, and maintenance service providers shall cooperate with the supervision and inspection conducted by the food and drug administration authorities, truthfully provide relevant information and documentation, and shall not refuse or conceal any such information.
 
Article 24: Medical device user establishments shall, in accordance with these Measures and the medical device use quality management system established by their own institutions, conduct a comprehensive self-inspection of their medical device quality management work annually and prepare a self-inspection report. The food and drug administration authorities shall, during supervisory inspections, conduct random checks on the self-inspection reports submitted by medical device user establishments.
 
Article 25: The food and drug administration authorities shall strengthen random inspections and testing of medical devices at the point of use. Food and drug administration authorities at or above the provincial level shall, based on the results of such inspections and tests, promptly issue public announcements on the quality of medical devices.
 
Article 26: Individuals and organizations who discover that a medical device user has engaged in conduct in violation of these Measures shall have the right to report such conduct to the food and drug administration authority at the location of the medical device user. The food and drug administration authority receiving the report shall promptly verify and address it. If the report is substantiated upon investigation, the informant shall be rewarded in accordance with the relevant provisions.
 
Chapter Five: Legal Liability
 
Article 27: If a medical device user falls under any of the following circumstances, the food and drug administration department at or above the county level shall impose penalties in accordance with Article 66 of the Regulations on the Supervision and Administration of Medical Devices:
 
(1) Using medical devices that do not comply with mandatory standards or with the product technical requirements that have been registered or filed;
 
(2) Using medical devices without valid certification documents, or using devices that are expired, invalidated, or obsolete, or using medical devices that have not been registered in accordance with the law.
 
Article 28: If a medical device user falls under any of the following circumstances, the food and drug administration department at or above the county level shall impose penalties in accordance with Article 67 of the Regulations on the Supervision and Administration of Medical Devices:
 
(1) Failure to store medical devices in accordance with the requirements specified in the product instructions and on the labels;
 
(2) Transferring or donating in-use medical devices that are expired, invalidated, obsolete, or have failed inspection.
 
Article 29: If a medical device user falls under any of the following circumstances, it shall be subject to penalties imposed by the food and drug administration department at or above the county level in accordance with Article 68 of the Regulations on the Supervision and Administration of Medical Devices:
 
(1) Failing to establish and implement a system for inspecting and verifying the procurement of medical devices, failing to verify the qualifications of suppliers, or failing to record the details of such inspections truthfully, completely, and accurately;
 
(2) Failure to conduct, in accordance with the requirements of the product manual, regular inspections, tests, calibrations, servicing, and maintenance, and to keep records thereof;
 
(3) Discovering that a medical device in use poses a safety hazard and failing to immediately cease its use, notify it for repair, or continuing to use a medical device that, even after repair, still fails to meet safety standards;
 
(4) Failure to properly retain the original records of purchases of Class III medical devices;
 
(5) Failure to establish and maintain records of the use of implantable and interventional medical devices as required.
 
Article 30: If a medical device user falls under any of the following circumstances, the food and drug administration department at or above the county level shall order it to make corrections within a specified time limit and issue a warning; if it refuses to make corrections, it shall be subject to a fine of no more than RMB 10,000:
 
(1) Failing to establish, in accordance with regulations, a medical device quality management organization or appoint quality management personnel commensurate with the scale of operations, or failing to put in place, as required, a usage‑quality management system that covers the entire quality‑management process;
 
(2) Failure to procure medical devices in a unified manner through the designated department or personnel as required;
 
(3) Purchasing or using Class I medical devices that have not been filed, or purchasing Class II medical devices from an unfiled business entity;
 
(4) The premises, facilities, and conditions for storing medical devices are not commensurate with the types and quantities of such devices, or the stored medical devices have not been subject to regular inspections and records in accordance with storage requirements and the expiration dates of the devices;
 
(5) Failure to establish and implement, as required, a pre-use quality inspection system for medical devices;
 
(6) Failure to request and retain records related to the maintenance and repair of medical devices as required;
 
(7) Failure to conduct training and assessment, and to establish training records, for the technical personnel of this entity engaged in the maintenance and repair of medical devices as required;
 
(8) Failure to conduct a self‑inspection of its medical device quality management in accordance with the relevant regulations and to prepare a self‑inspection report.
 
Article 31: If a medical device manufacturing or operating enterprise violates the provisions of Article 17 of these Measures by failing to provide maintenance and repair services as required, or by failing to furnish the materials and information necessary for such maintenance and repair, the food and drug administration department at or above the county level shall issue a warning and order it to make corrections within a specified time limit. In cases of serious violations or refusal to correct, a fine of no less than RMB 5,000 but no more than RMB 20,000 shall be imposed.
 
Article 32: If medical device user institutions, manufacturers and operators, maintenance service providers, or other relevant entities fail to cooperate with the supervisory inspections conducted by the food and drug administration authorities, or refuse to provide, conceal, or submit false information and materials, the food and drug administration authorities at or above the county level shall order them to make corrections and issue a warning; they may also impose a fine of no more than RMB 20,000.
 
Chapter VI Supplementary Provisions
 
Article 33: Quality management of investigational medical devices used in clinical trials shall be conducted in accordance with the relevant provisions governing clinical trials of medical devices.
 
Article 34: Supervision and administration of the use of medical devices in the utilization stage shall be carried out in accordance with the relevant provisions of the National Health and Family Planning Commission.
 
Article 35 This Measures shall come into force on February 1, 2016.