The Guidance Opinions of the Comprehensive Department of the State Drug Administration on Strengthening the Horbon Supervision of Medical Device Production and Management

Provincial, autonomous regions, municipalities, and Xinjiang Production and Construction Corps Drug Administration:

In order to implement the "Regulations on the Supervision and Administration of Medical Device", implement the "Measures for the Supervision and Management of Medical Device Production and Management" and "Measures for the Supervision and Management of Medical Device Management", further strengthen the supervision of medical device production and operation, scientifically and reasonably allocate supervision resources, ensure medical device in accordance with the law, Safety and effectiveness, promote the new improvement of the quality and safety level of medical equipment, and now propose the following guidance.

1. Overall requirements

Drug supervision and management departments at all levels shall conscientiously implement the "Regulations on the Supervision and Administration of Medical Device", "Measures for the Supervision and Management of Medical Devices", and "Measures for the Supervision and Management of Medical Device Management", in accordance with the "risk grading, scientific supervision, comprehensive coverage, dynamic adjustment, implementation of implementation, implementation The principles of responsibility and improvement ", carry out hierarchical supervision of medical device production and operation, consolidate the supervision responsibilities of drug supervision departments at all levels, establish and improve the scientific and efficient regulatory model, strengthen the supervision and management of medical device production and operation, and ensure the safety of the people.

2. Carry out the supervision of medical device production classification

(1) Implement the responsibilities of production classification supervision. The State Drug Administration is responsible for guiding and inspecting the national medical device production classification supervision, formulating the catalog of key supervision of medical device production; the drug supervision and management departments of the province, autonomous region, and municipality directly under the Central Government is responsible for formulating the category of key regulatory species of medical device production in their own administrative region, organizing and implementing it Medical device production classification supervision; municipal -level municipal -level responsible for drug supervision and management department is responsible for the specific work of the production grading supervision of the first type of medical device production in accordance with the responsibilities in accordance with the law.

(2) Based on the actual situation, determine the catalog of key regulatory varieties. The State Drug Administration formulated and dynamically adjusted the category of supervision of medical device production according to the degree of risk of medical device products (see Annex 1); the drug supervision and management departments of provinces, autonomous regions, and municipalities shall comprehensively analyze the number of similar products in the administrative region and the market possession of the market. The overall level of production quality management and the situation of risk discussions, supplement the directory formulated by the State Drug Administration, determine the catalog of key supervision of the production area of ​​the administrative regional medical device and make dynamic adjustments.

For registered medical device registrations entrusted by regional commissioned regions, the drug supervision and management departments of the registered provinces, autonomous regions, and municipalities are responsible for studying and determining whether their products are included in the key varieties of supervision of medical device production in their own administrative region.

(3) Formulate detailed regulations for hierarchical supervision. The drug supervision and management departments of the province, autonomous region, and municipalities shall formulate and issue medical device production hierarchical supervision and detailed regulations in accordance with the development of the industrial development of their administrative regions, the status of enterprise quality management, and the deployment of regulatory resources in their own administrative regions, clarify the principles of regulatory level division, as well as different regulatory levels Registers of medical device registered personnel and the supervision and inspection form, frequency, and coverage of the trustees' production enterprises.

The regulatory level division and inspection requirements can be followed by the following principles:

The implementation of four -level supervision of enterprises with high risk levels mainly includes the production of key varieties of the administrative regional regulatory varieties, as well as enterprises with poor operating conditions and severe bad regulatory credit records of the quality management system;

Three -level supervision of enterprises with high risk levels mainly include the production of third categories of medical devices in addition to the key species of administrative regions, as well as enterprises with poor operating conditions and bad supervision credit records in the quality management system;

Implementing secondary supervision of enterprises with average risk levels mainly include the production of enterprises that produce second categories of medical devices other than the catalogs of key regulatory varieties in their administrative regions;

The first -level supervision of enterprises with lower risk levels mainly includes enterprises that produce first medical devices.

Those who involve multiple regulatory levels shall be supervised according to the highest level.

Under normal circumstances, the enterprises that implement four -level supervision are inspected not less than once a year; for the implementation of three -level supervision, it is not less than once a year, of which the whole project is inspected not less than once every two years; In principle, the inspection is not less than once every two years; in the implementation of first -level supervision, in principle, more than 25%of enterprises in this administrative area are randomly selected for supervision and inspection, and the new first type of medical device production enterprise is added On -site inspections will be carried out within 3 months from the date of production filing. If necessary, on -site inspections are conducted on the first type of medical device manufacturers with changes in production address or increasing production scope of production. Supervision and inspection can be combined with product registration system verification, production permit change or continuing on -site verification to improve the effectiveness of supervision.

The inspection of the entire project refers to the inspection of all applicable projects carried out by the drug supervision and management department in accordance with the quality management specifications of medical device production and the corresponding appendix. The entire project inspection carried out by the registor of the commissioned medical device shall include the inspection of the corresponding production activities of the trusted production enterprise.

(4) Dynamic adjustment supervision level. The drug supervision and management departments of the province, autonomous region, and municipalities shall be organized in accordance with the detailed regulations of the medical device production classification supervision and detailed regulations, and organize the registered register of the administrative regional medical device registration every year Persons with a record person and trusted production enterprise conduct scientific research and judgment, determine the level of supervision and inform the enterprise. For serious quality accidents in the recorder of the medical device registered in the year, and the trustee's production enterprise, new high -risk products, national centralized band procurement products, and innovative products should be added in real time.

For enterprises with better supervision and credit status for a long time, the level of supervision can be reduced as appropriate; for the obtaining product listing license to obtain product listing licenses by entrusted production methods or passing the approval channel for innovative medical device review, and registered medical device registered by cross -regional commissioned production, only the trustees are performed For the production enterprises produced, the registered registor of the medical device of the country's selected products in the country, and the trustee's production enterprise shall adjust the supervision level as appropriate. The specific adjustment methods are determined by the provincial, autonomous regions, and municipal drug supervision departments in accordance with the overall supervision and credit status of enterprises in the administrative region, the number of enterprises, and the proportion of regulatory resources.

(5) Strengthen supervision and inspection according to the supervision level. The drug supervision and management departments of provinces, autonomous regions, and municipalities shall formulate annual supervision and inspection plans in accordance with the provisions of hierarchical supervision, clarify the frequency and coverage rate of inspection, and determine the focus of supervision; adhere to the problem -oriented, comprehensively use supervision and inspection, key inspections, tracking inspections, and cause inspection And special inspections such as special inspections to strengthen supervision and management. Supervision and inspection can be carried out in a non -pre -notification manner, focusing on inspection, and in principle of inspection and special inspection in principle.

For medical device registrars and their trustee production enterprises through the National Drug Administration's innovative medical device review and approval channel, they should fully consider the regulatory risk points and regulatory measures determined by the Innovation Medical Device Supervision Association; for the suspension of production due Enterprises that cause the quality management system to continue to operate effectively shall follow the relevant situation and take targeted regulatory measures.

3. Carry out the supervision of medical device management

(6) Implement the duties of operating hierarchical supervision. The State Drug Administration is responsible for guiding and inspecting the hierarchical supervision of national medical device operations, and formulated a catalog of key supervision of medical device operations; the drug supervision and management departments of the province, autonomous region, and municipality directly under the Central Government is responsible for guiding and inspecting the municipal -level drug supervision and management of the district. The department implements the hierarchical supervision of medical device operations; the municipal -level municipal -level responsible for drug supervision and management departments are responsible for formulating the catalog of key supervision varieties of medical device operations in this administrative region, organizing and implementing medical device management graded supervision; Responsible for the specific supervision of medical device operations in this administrative area.

For medical device business enterprises that add warehouses in cities with cross -setting areas, in accordance with the principles of territorial management, the municipal -level municipal -level departments that are responsible for drug supervision and management in the place where the business enterprises and warehouses are located are responsible for determining their supervision levels and implementing supervision.

(7) Based on the actual actual situation, the catalog of key regulatory varieties. The State Drug Administration formulates and dynamically adjusts and dynamically adjusts the catalog of medical device operations (see Annex 2) according to the degree of operating risk of medical device products and products (see Annex 2); Adverse events monitoring, product recall, quality complaints, and risk discussions, supplement the directory formulated by the State Drug Administration, determine the catalog of key regulatory varieties of medical device operations in the administrative region and make dynamic adjustments.

For medical device business enterprises that add warehouses in cities with cities, the municipal -level municipal -level department in the area where the warehouse is located is responsible for determining whether its inventory products belong to the key supervision products of medical device operations in this administrative region.

(8) Formulate detailed regulations for hierarchical supervision. The municipal -level municipal -level responsible for drug supervision and management departments shall formulate and print in accordance with factors such as the risk, business formats, quality management levels, and corporate supervision of medical device operations in this administrative region. The detailed regulations of hierarchical supervision, clarify the principle of regulatory level division, and the form, frequency and coverage of supervision and inspection of medical device business enterprises at different regulatory levels.

The regulatory level division and inspection requirements can be performed in accordance with the following principles:

Implementation of four -level supervision of enterprises with high risk levels mainly include "registered registered by other medical device, recorder and production and operation enterprises that specialize in providing storage and transportation services" and key inspection companies determined by risk conferences;

Three -level supervision of enterprises with high risk levels mainly include wholesale enterprises involved in the key supervision varieties of medical device operations in this administrative regional medical device.

Implementing secondary supervision of enterprises with average risk levels mainly include wholesale enterprises that operate secondary and third -level medical devices except third and fourth -level supervision, and retail enterprises involved in key regulatory products in the administrative regional medical device operations;

The implementation of first -level supervision of enterprises with lower risk levels mainly includes other medical device business enterprises except 2, third, and fourth supervision.

Those who involve multiple regulatory levels shall be supervised according to the highest level.

Enterprises that implement four levels of supervision, the municipal -level municipal -level responsible drug supervision and management departments organize the entire project to inspect the entire project for not less than once; enterprises that implement third -level supervision, and the municipal -level city -level dyeing department responsible for drug supervision and management will organize inspection every year. It is less than once, and the entire project inspection is not less than once every two years; enterprises that implement secondary supervision, county -level responsible for drug supervision and management departments organize no less than once every two years. Retail enterprises can determine the frequency of inspection according to the needs of supervision; enterprises that implement first -level supervision, county -level responsible for drug supervision and management departments in accordance with relevant requirements, randomly extract more than 25%of enterprises in this administrative area for supervision and inspection, and reach full coverage within 4 years. If necessary, conduct on -site inspections of newly operated enterprises. The inspection of the entire project refers to the inspection of all applicable projects carried out by the drug supervision and management department in accordance with the quality management specifications of medical device operations and the corresponding appendix. The entire project inspection carried out by the "registered by other medical device, the filing of the filing, and the production and operation enterprise provides storage and transportation services" shall include the spot checks on the commissioned business enterprise.

(9) Dynamic adjustment supervision level. The municipal -level municipal -level responsible for drug supervision and management departments shall, in accordance with the detailed regulations of medical device operations, on the basis of comprehensively and effectively collecting information such as medical device products, enterprises, and supervision, organize each year to organize the administrative regional medical device operation enterprises, Medical device business enterprises with increasing warehouses in cities in cities are evaluated, scientifically judged the degree of risk of enterprises, determined the level of supervision and informed the enterprise. Special circumstances such as new business formats can be determined or adjusted immediately or adjusted the level of corporate supervision.

For enterprises with better supervision and credit conditions for a long time, the level of supervision can be reduced as appropriate; for the existence of serious violations of laws and regulations, renovation of warehouses, national centralized band procurement products and epidemic prevention and control products, the supervision level shall be adjusted as appropriate. The specific adjustment method is determined by the municipal -level municipal -level responsible and drug supervision departments in accordance with the overall supervision of the overall supervision of the enterprise in the administrative region, the number of enterprises, and the ratio of supervision resources.

(10) Strengthen supervision and inspection according to the supervision level. The local department responsible for drug supervision and management at all levels shall formulate the annual supervision and inspection plan according to the supervision level, and clearly check the key, inspection methods, frequency of inspection and coverage. In principle, the inspection method should be adopted by assault supervision and inspection, and the use of modern information technology to implement supervision and management to improve the efficiency and level of supervision.

4. Strengthen supervision and management and improve supervision effectiveness

(11) Strengthen organizational leadership. Drug supervision and management departments at all levels must effectively improve their political standing, fully understand that under the situation of significant increase in the number of regulators, the comprehensive implementation of the registor's record system, and the endless operation of the new business format The significance. All provincial pharmaceutical supervision and management departments shall be deployed in accordance with the unified deployment of the State Drug Administration, strengthen coordination and coordination, play a leading role, establish and improve cross -regional cross -level collaborative supervision mechanisms, strengthen cooperation and cooperation, strengthen cities and county -level responsible drug supervision and management The supervision and guidance of the department's work, linking up and down, and promoting the hierarchical supervision of medical device production and operation.

(12) Strengthen the problem disposal. The local drug supervision and management departments at all levels shall implement the "four most stringent" requirements. For the problems found in the inspection, it shall be dealt with strictly in accordance with the requirements of regulations, regulations, standards, and specifications. Department report. For new problems in the development of the industry, the relevant drug supervision departments shall timely adjust and improve the detailed regulations of hierarchical management, realize the precision, scientific and effective supervision, and ensure that the supervision is full coverage and seamless gap. Provincial drug supervision and management departments shall regularly organize experts to study and judge the safety situation of medical device production and operation in their own administrative region, analyze common problems, highlight problems, and weak links, and propose improvement measures to form an annual report.

(13) Strengthen capacity building. Drug supervision and management departments at all levels should continue to strengthen capacity building, improve the inspection law enforcement system and audit case handling mechanism, enrich professional professional inspectors, strengthen the construction of audit teams, innovate inspection methods and methods, and strengthen inspection and audit collaboration and law enforcement linkage. Drug supervision and management departments at all levels should find the shortcomings of supervision capabilities, clarify the goals and construction directions of supervision capacity, enrich regulatory resources, promote scientific distribution, promote the high -quality development of the medical device industry, better meet the safety of the people for medical device safety need.

This guidance will be implemented from January 1, 2023. The former State Food and Drug Administration's "Notice on Printing and Distributing the" Regulations on the Provisions of the Classification and Holocating Supervision and Management of Medical Device Manufacturers "(Food and Drug Administration [2014] No. 234)," Notice on Printing and Distributing the Catalog of National Key Supervision Medical Device "( Food and Drug Administration [2014] No. 235), "Notice on Printing and Distributing the Provisions on Classification Supervision and Management of Medical Device Management Enterprises" (Food and Drug Administration [2015] No. 158) and "Key Supervision Catalog of Medical Device Operations links And on -site inspection of the key content "(Food and Drug Supervision [2015] No. 159) was abolished at the same time.

Attachment: 1. Catalog of key supervision of medical device production

2. Catalog of key supervision varieties of medical device operations

Comprehensive Department of the State Drug Administration

September 7, 2022

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