Drug Administration of all provinces, autonomous regions, municipalities directly under the Central Government and Xinjiang Production and Construction Corps:

In order to implement the "Regulations on the Supervision and Administration of Medical Devices", implement the requirements of the "Measures for the Supervision and Administration of Medical Device Production" and the "Measures for the Supervision and Administration of Medical Device Operations", further strengthen the supervision of medical device production and operation, scientifically and rationally allocate regulatory resources, and protect medical devices in accordance with the law. To be safe and effective, and to promote the new improvement of the quality and safety level of medical devices, the following guiding opinions are hereby offered.

1. General requirements

Drug supervision and administration departments at all levels should conscientiously implement the requirements of the Regulations on the Supervision and Administration of Medical Devices, the Measures for the Supervision and Administration of Medical Device Production, and the Measures for the Supervision and Administration of Medical Device Operations, and follow the requirements of "risk classification, scientific supervision, comprehensive coverage, dynamic adjustment, and implementation." Responsibility and improving efficiency" principle, carry out the hierarchical supervision of medical device production and operation, consolidate the supervision responsibility of drug regulatory departments at all levels, establish and improve a scientific and efficient supervision model, strengthen the supervision and management of medical device production and operation, and ensure the safety of the people's use of equipment.

2. Carry out hierarchical supervision of medical device production

(1) Implement the responsibilities of production classification supervision. The State Drug Administration is responsible for guiding and inspecting the grading supervision of medical device production nationwide, and formulating the catalogue of key varieties of medical device production under supervision; the drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government are responsible for formulating the catalogue of key varieties of medical device production under the supervision of their respective administrative regions, and organize the implementation of the catalogue. The work of grading supervision over the production of medical devices; the department in charge of drug supervision and administration at the municipal level divided into districts shall be responsible for the specific work of grading supervision of the production of Class I medical devices in their respective administrative regions according to their duties and responsibilities.

(2) Determine the catalogue of key regulated varieties in light of the actual situation. The State Drug Administration shall formulate and dynamically adjust the list of key regulated varieties of medical device production according to the risk level of medical device products (see Annex 1); the drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall comprehensively analyze the registered quantity and market share of similar products in their respective administrative regions. Factors such as the rate of production, the overall level of production quality management and the situation of risk consultations, supplement the catalogues formulated by the State Drug Administration, determine the catalogues of key regulated varieties of medical device production in the administrative region, and make dynamic adjustments.

For the registrant of medical device production entrusted across regions, the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where the registrant is located shall be responsible for researching and determining whether its product is included in the list of key regulated varieties of medical device production in the administrative region.

(3) Formulate detailed regulations on hierarchical supervision. The drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall formulate and issue detailed regulations on the hierarchical supervision of medical device production based on the industrial development of their respective administrative regions, the status of enterprise quality management and the allocation of regulatory resources, clarify the principles for the division of regulatory levels, as well as the requirements for different regulatory levels. The form, frequency and coverage of supervision and inspection of medical device registrants and filers and entrusted manufacturers.

The division of supervision levels and inspection requirements can be based on the following principles:

Implement four-level supervision on enterprises with high risk levels, mainly including the production of products in the catalogue of key supervision varieties in the administrative region, as well as enterprises with poor quality management system operation and serious bad supervision credit records;

Implement three-level supervision for enterprises with higher risk levels, mainly including the production of third-class medical devices other than the catalogue of key supervision varieties in the administrative region, as well as enterprises with poor quality management systems and poor regulatory credit records;

Implement second-level supervision on enterprises with average risk levels, mainly including enterprises producing second-class medical devices other than the catalogue of key supervision varieties in the administrative region;

Implement first-level supervision on companies with lower risk levels, mainly including companies producing Class I medical devices.

Where multiple levels of supervision are involved, supervision shall be conducted at the highest level.

Under normal circumstances, for enterprises that implement four-level supervision, the whole project inspection is not less than once a year; for enterprises that implement three-level supervision, the inspection is not less than once a year, and the whole project inspection is not less than once every two years; For first-level supervision, in principle, inspections shall be carried out no less than once every two years; for first-level supervision, in principle, more than 25% of the enterprises in the administrative area shall be randomly selected for supervision and inspection every year, and the newly added first-class medical device manufacturers shall be inspected. Carry out on-site inspections within 3 months from the date of production filing, and conduct on-site inspections of Class I medical device manufacturers whose production address is changed or whose production scope is increased if necessary. Supervision and inspection can be combined with product registration system inspections, production license changes, or continuation of on-site inspections, etc., to improve supervision efficiency.

The full-item inspection refers to the inspection of all applicable items carried out by the drug regulatory department in accordance with the Good Manufacturing Practice for Medical Devices and the corresponding appendices. The whole-item inspection carried out by the filer of the entrusted production medical device registrant shall include the inspection of the corresponding production activities of the entrusted production enterprise.

(4) Dynamically adjust the level of supervision. The provincial, autonomous region and municipal drug administration departments shall, in accordance with the detailed regulations on the hierarchical supervision of medical device production, take into account the supervision and inspection, supervision and random inspection, adverse event monitoring, product recall, complaint reporting and case investigation, etc., organize the registration of medical devices in their respective administrative regions every year. The risk level of the person filing person and the entrusted production enterprise shall be scientifically researched and judged, the supervision level shall be determined, and the enterprise shall be informed. In the case of serious quality accidents of medical device registrants and entrusted production enterprises in the current year, new high-risk products, products selected by the state’s centralized procurement of large quantities, innovative products, etc., the supervision level should be immediately assessed and adjusted.

For enterprises with a long-term good regulatory credit status, the regulatory level can be lowered as appropriate; for medical device registrants who have obtained product marketing licenses through entrusted production or through innovative medical device review and approval channels, and cross-regional entrusted production, only entrusted The entrusted production enterprises, the medical device registrant filers and the entrusted production enterprises that the state purchases the selected products in a centralized manner, shall raise the supervision level as appropriate. The specific adjustment method shall be determined by the drug regulatory departments of the provinces, autonomous regions and municipalities directly under the Central Government in combination with the overall regulatory credit status of enterprises in their respective administrative regions, the number of enterprises and the allocation of regulatory resources.

(5) Strengthen supervision and inspection according to the supervision level. The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall formulate annual supervision and inspection plans in accordance with the regulations on hierarchical supervision, clarify the frequency and coverage of inspections, and determine the focus of supervision; adhere to problem orientation, and comprehensively apply supervision and inspection, key inspections, follow-up inspections, and cause-based inspections. and special inspections and other forms to strengthen supervision and management. Supervision and inspection may be conducted in a non-pre-announced manner, and key inspections, causal inspections and special inspections are in principle conducted in a non-pre-announced manner.

For medical device registrants and their entrusted manufacturers who have obtained product marketing licenses through the State Drug Administration's innovative medical device review and approval channel, they should fully consider the regulatory risk points and regulatory measures determined by the innovative medical device regulatory consultation; Enterprises that lead to the inability of the quality management system to operate continuously and effectively should track the relevant situation and take targeted regulatory measures.

3. Carry out hierarchical supervision of medical device operation

(6) Implementing the responsibilities of hierarchical supervision of business operations. The State Drug Administration is responsible for guiding and inspecting the hierarchical supervision of medical device business across the country, and formulating a catalogue of key varieties of medical device business under supervision; the drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government are responsible for guiding and inspecting district-level cities responsible for drug supervision and administration. The department implements the hierarchical supervision of medical device operation; the department in charge of drug supervision and administration at the districted city level is responsible for formulating the catalogue of key supervision varieties of medical device operation in its administrative region, and organizes the implementation of the hierarchical supervision of medical device operation; the county-level department responsible for drug supervision and management Responsible for the specific work of hierarchical supervision of medical device operations within the administrative region.

For a medical device operating enterprise that has added a warehouse in a city divided into districts, in accordance with the principle of territorial management, the department responsible for drug supervision and management at the city level with the districted city where the operating enterprise and the warehouse are located shall be respectively responsible for determining its supervision level and implementing the supervision work.

(7) Determine the catalogue of key regulated varieties in light of the actual situation. The State Drug Administration shall formulate and dynamically adjust the catalogue of key regulatory varieties of medical device business according to the risk level of medical device products and product business (see Annex 2); Adverse event monitoring, product recalls, quality complaints, risk consultations and other factors, supplement the catalogues formulated by the State Drug Administration, determine the catalogues of key regulated varieties of medical device business in the administrative region, and make dynamic adjustments.

For a medical device business enterprise that has additional warehouses in a city divided into districts, the department responsible for drug supervision and administration at the city level with districts where the warehouse is located is responsible for determining whether the products in its inventory belong to the key supervision products of medical device business in the administrative region.

(8) Formulate detailed regulations on hierarchical supervision. The department in charge of drug supervision and administration at the city level with districts shall formulate and issue the regulations based on the risk level, business format, quality management level and corporate regulatory credit status of medical device operations in their respective administrative regions, as well as factors such as medical device adverse events and product complaints. The regulations on hierarchical supervision shall be refined, and the principle of division of supervision levels shall be clarified, as well as the form, frequency and coverage of supervision and inspection of medical device operating enterprises of different levels of supervision.

The division of supervision levels and inspection requirements can be carried out in accordance with the following principles:

Implement four-level supervision on enterprises with a high degree of risk, mainly including "specially providing storage and transportation services for other medical device registrants, filers and production and operation enterprises" and key inspection enterprises determined by risk consultation;

Implement three-level supervision on enterprises with a higher degree of risk, mainly including wholesale enterprises involved in the products in the key supervision varieties of medical device business in the administrative region, and operating enterprises with administrative penalties or bad supervision credit records in the previous year;

Second-level supervision shall be implemented for enterprises with average risk level, mainly including wholesale enterprises operating second- and third-level medical devices other than third-level and fourth-level supervision, and retail enterprises involved in the products in the key categories of medical device operation in the administrative region;

Implement first-level supervision on enterprises with lower risk levels, mainly including other medical device business enterprises other than second-, third-, and fourth-level supervision.

If multiple levels of supervision are involved, they shall be regulated at the highest level.

For enterprises that implement four-level supervision, the department in charge of drug supervision and administration at the city-divided city level shall organize an inspection of the whole project at least once a year; Less than once, of which the entire project inspection is not less than once every two years; for enterprises that implement secondary supervision, the county-level department responsible for drug supervision and management organizes inspections not less than once every two years. Contact lenses and protective products Retail enterprises can determine the frequency of inspections according to regulatory needs; for enterprises that implement first-level supervision, the county-level department in charge of drug supervision and management shall randomly select more than 25% of the enterprises in their administrative areas for supervision and inspection every year, and achieve full coverage within 4 years. When necessary, conduct on-site inspections of new businesses.

The full-item inspection refers to the inspection of all applicable items carried out by the drug regulatory department in accordance with the Good Management Practice for Medical Device Operation and the corresponding appendices. The whole-item inspection of the operating enterprises that "provide storage and transportation services for other medical device registrants, filers, and production and operation enterprises" shall include random inspections of the entrusted operating enterprises.

(9) Dynamic adjustment of supervision levels. The department in charge of drug supervision and administration at the city level divided into districts shall, in accordance with the detailed regulations on the hierarchical supervision of medical device business, on the basis of comprehensive and effective collection of information on medical device products, enterprises and supervision, organize annual inspections of medical device business enterprises, The medical device business enterprises that have added warehouses in cities with different districts shall conduct evaluations, scientifically study and judge the risk level of the enterprises, determine the supervision level and inform the enterprises. For special circumstances such as new business formats, the corporate supervision level can be determined or adjusted immediately.

For enterprises with good regulatory credit status for a long time, the regulatory level may be lowered as appropriate; for enterprises with serious violations of laws and regulations, additional warehouses in different places, national centralized procurement of selected products and products for epidemic prevention and control, the regulatory level should be raised as appropriate. The specific adjustment method shall be determined by the department in charge of drug supervision at the city level divided into districts in combination with the overall supervision credit status of enterprises in the administrative region, the number of enterprises and the allocation of supervision resources.

(10) Strengthen supervision and inspection according to the supervision level. The local departments responsible for drug supervision and administration at all levels shall, according to the level of supervision, formulate an annual supervision and inspection plan, specifying the inspection priorities, inspection methods, inspection frequency and coverage. In principle, the inspection method should adopt surprise supervision and inspection, encourage the use of modern information technology means to implement supervision and management, and improve the efficiency and level of supervision.

Fourth, strengthen supervision and management, improve supervision efficiency

(11) Strengthen organizational leadership. Drug supervision and administration departments at all levels should effectively improve their political positions, fully understand that under the situation of a substantial increase in the number of supervision objects, the full implementation of the registrant filer system, and the continuous emergence of new business formats, they should further strengthen hierarchical supervision, improve supervision efficiency, and promote risk management. significance. All provincial drug supervision and administration departments shall, in accordance with the unified deployment of the State Drug Administration, strengthen overall planning and coordination, play a leading role, establish and improve a cross-regional and cross-level collaborative supervision mechanism, strengthen cooperation and cooperation, and strengthen the supervision and management of drugs at the city and county levels. The supervision and guidance of the work of the departments, the linkage between the top and the bottom, and the integrated promotion of the hierarchical supervision of the production and operation of medical devices.

(12) Strengthen problem handling. Local drug supervision and management departments at all levels shall implement the "four strictest" requirements, and deal with problems found in inspections in strict accordance with regulations, rules, standards, norms and other requirements. department report. For new problems arising in the development of the industry, the relevant drug regulatory authorities should adjust and improve the detailed regulations on hierarchical management in a timely manner to achieve precise, scientific, and effective supervision, and ensure full coverage and seamless supervision. Each provincial drug administration department shall regularly organize experts to study and judge the safety situation of medical device production and operation in their respective administrative regions, analyze common problems, prominent problems and weak links, propose improvement measures, and form an annual report.

(13) Strengthen capacity building. Drug supervision and administration departments at all levels should continue to strengthen capacity building, improve the inspection and law enforcement system and the inspection and case handling mechanism, enrich the team of professional and professional inspectors, strengthen the construction of inspection teams, innovate inspection methods and methods, and strengthen inspection and inspection coordination and law enforcement linkage. Drug supervision and administration departments at all levels should find the shortcomings of supervision capacity, clarify the goals and directions of supervision capacity building, enrich supervision resources, promote scientific distribution, boost the high-quality development of the medical device industry, and better meet the people's concerns about the safety of medical devices. need.

These guidelines will come into force on January 1, 2023. The former State Food and Drug Administration "Notice on Printing and Distributing the "Regulations on the Classification and Hierarchical Supervision and Administration of Medical Device Manufacturing Enterprises" (Food and Drug Administration [2014] No. 234), "Notice on Printing and Distributing the Catalogue of National Key Supervision Medical Devices" ( Food and Drug Administration Jian Jian [2014] No. 235), the "Notice on Printing and Distributing the Regulations on the Classification and Hierarchical Supervision and Administration of Medical Device Business Enterprises" (Food and Drug Administration Jian Jian [2015] No. 158) and "Medical Device Operation Key Supervision Catalogue" and Key Contents of On-site Inspection" (Food and Drug Administration and Equipment Supervision [2015] No. 159) shall be repealed at the same time.

  Attachment:  

1、List of key supervised varieties of medical device production

2、Catalogue of key regulated varieties of medical devices

General Department of the State Food and Drug Administration

September 7, 2022