Regulations on the Classification and Supervision of Medical Device Businesses

Chapter 1 General Provisions

Article 1 These regulations are formulated in accordance with the "Regulations on the Supervision and Administration of Medical Devices" and the "Measures for the Supervision and Administration of Medical Device Business", etc., to improve the scientific level of supervision and management of medical device business enterprises, clarify the supervisory responsibilities of food and drug supervision and administration departments at all levels, enhance regulatory efficiency, and ensure public safety in the use of medical devices.

Article 2 The classified and graded supervision and management in these regulations refers tothe risk level of medical devices, the business model of medical device business enterprises, the level of quality management, and compliance with regulations, combined with adverse events of medical devices and product complaintsand other factors, medical device business enterprises are divided into different categories, and according tolocal supervisionprinciplesto implement dynamic management activities.

Article 3 These regulations apply to the entire process of classified and graded supervision and management activities of medical device business enterprises by food and drug supervision and administration departments at all levels.

Article 4 The State Food and Drug Administration is responsible for guiding and inspecting the classified and graded supervision and management work of medical device business enterprises nationwide.
 

Provincial food and drug supervision and administration departments are responsible for compiling the supervision and inspection plan for medical device business enterprises in the province, and supervising the implementation of the classified and graded supervision and management work of medical device business enterprises.
 

City-level food and drug supervision and administration departments with districts under their jurisdiction shall determine the supervision level of medical device business enterprises within their administrative regions based on the actual situation, clarify the key supervision points, specify the inspection frequency and coverage rate, and organize the implementation.
 

County (district)-level food and drug supervision and administration departments are responsible for the specific work of classified and graded supervision and management of medical device business enterprises within their administrative regions.

Chapter 2 Classification and Grading of Business Enterprises

Article 5 The State Food and Drug Administration, based on the special storage and transportation requirements of products in the business link, and the situation of supervision and inspection, adverse event monitoring, risk monitoring, and recall, as well as products with many quality complaints and high social attention, shall formulate and publish the "Key Supervision Catalog and Key Content of On-site Inspection for Medical Device Business Links".

Article 6 Medical device business enterprises are divided intothree supervision levels.
 

Level 3 supervision is the highest risk level supervisionmainly for business enterprises involved in the key supervision catalog of medical device business links, business enterprises that provide storage and distribution services for other medical device production and business enterprises, and business enterprises that have been administratively punished in the previous year and have not been rectified, and those with poor credit records.
 

Level 2 supervision is the general risk level supervision, mainly for wholesale enterprises of Class II and Class III medical devices other than Level 3 supervision.
 

Level 1 supervision is the lower risk level supervision, mainly for other medical device business enterprises other than Level 2 and Level 3 supervision.
 

For medical device business enterprises involving multiple supervision levels, they shall be supervised according to the highest level.
 

Article 7 The determination of the supervision level of medical device business enterprises shall be carried out annually and announced to the public. For enterprises with serious illegal and irregular behaviors or special circumstances such as the addition of business models, the supervision level of enterprises can be immediately determined and adjusted. Food and drug supervision and administration departments at all levels shall carry out corresponding supervision and management according to the determined level.

Chapter 3 Supervision Measures

Article 8 Local food and drug supervision and administration departments at all levels shall urge medical device business enterprises to adopt effective quality control measures in accordance with the requirements of the "Medical Device Business Quality Management Specifications" to ensure the quality and safety of products during the business process and prevent major medical device quality accidents.

Article 9 Local food and drug supervision and administration departments at all levels shall formulate supervision plans according to the supervision level and strengthen supervision and management by comprehensively using various forms such as full-item inspections, flying inspections, follow-up inspections, and supervision and sampling inspections.

Article 10 City-level food and drug supervision and administration departments with districts under their jurisdiction shall formulate the frequency and coverage rate of supervision and inspection of medical device business enterprises within their administrative regions based on the actual supervision situation and the determined supervision level. The principles are as follows:
　　

（1）Implementation ofLevel 3 supervisionfor business enterprises, city-level food and drug supervision and administration departments with districts under their jurisdiction shall organizeat least one inspection per year,local areas can determine the inspection frequency for corneal contact lenses and family planning products according to the needs of supervision. The follow-up inspection coverage rate for rectified enterprises must reach 100% until the enterprises are rectified.

（2）Implementation ofLevel 2 supervisionfor business enterprises, county (district)-level food and drug supervision and administration departmentsshall conduct at least one inspection every two years.The follow-up inspection coverage rate for rectified enterprises must reach 100% until the enterprises are rectified.
 

（3）Implementation ofLevel 1 supervisionfor business enterprises, county (district)-level food and drug supervision and administration departments shall, in accordance with relevant requirements, randomlyselect more than 30% of enterprises within their administrative regionsfor supervision and inspection, achieving full coverage within 3 years.

Article 11 Provincial food and drug supervision and administration departments shall randomly select a certain proportion of medical device business enterprises within their administrative regions for supervision and inspection every year.

Article 12 For major quality accidents occurring in business enterprises, provincial food and drug supervision and administration departments shall promptly organize inspections and report to the State Food and Drug Administration at the same time. General quality accidents shall be inspected by city-level food and drug supervision and administration departments with districts under their jurisdiction.

Article 13 Local food and drug supervision and administration departments at all levels shall formulate and implement measures to strengthen supervision based on the actual supervision situation in their administrative regions for common problems, prominent problems, or weak links in enterprise quality management found during supervision. For major problems, they shall promptly report to the higher-level food and drug supervision and administration department.

Article 14 Local food and drug supervision and administration departments at all levels shall promptly and proactively disclose to the public the results of supervision and inspection, the results of sampling inspection of products operated by enterprises, and the opinions of investigations, etc. Both qualified and unqualified enterprises shall be disclosed.

Article 15 City-level and below food and drug supervision and administration departments with districts under their jurisdiction shall establish files for the classified and graded supervision and management of medical device business enterprises within their administrative regions. The supervision and management files shall include information on licensing and filing, supervision and inspection, supervision and sampling inspection, adverse event monitoring, product recall, punishment, and complaints and reports of medical device business enterprises. At the same time, they shall be entered into the medical device business enterprise supervision information system and updated regularly to ensure that relevant information is timely and accurate.

Article 16. Higher-level food and drug supervision and administration departments shall take measures to supervise and inspect the work of lower-level food and drug supervision and administration departments in carrying out classified and graded supervision and management of medical device business enterprises, and implement supervision responsibilities. For those who fail to implement supervision responsibilities, the local government may be notified.

Chapter 4 Supplementary Provisions

Article 17. Local food and drug supervision and administration departments at all levels implementThe supervision and inspection mainly includesComprehensive inspections, flying inspections, follow-up inspectionsetc.
 

A comprehensive inspection refers to an inspection carried out item by item in accordance with the quality management specifications for medical device business operations.
 

These provisionsFlying inspectionsrefer to unannounced supervision and inspection of medical device business enterprises.
 

Follow-up inspectionsrefer to the review inspection of the corrective measures and corrective effects of relevant issues of medical device business enterprises.

Article 18. These provisions shall come into force upon their issuance.