every province Autonomous Region Drug Administration of municipalities directly under the Central Government and Xinjiang Production and Construction Corps

To implement Regulations on Supervision and Administration of Medical Devices ,carry out Measures for the Supervision and Administration of the Production of Medical Devices  Measures for the Supervision and Administration of the Operation of Medical Devices requirement,Further strengthen the supervision of medical device production and operation,Scientific and rational allocation of regulatory resources,Ensuring the safety and effectiveness of medical devices according to law,Promote the quality and safety level of medical devices to achieve new improvement,The following guidance is proposed.

one General requirements

Drug regulatory departments at all levels should earnestly implement Regulations on Supervision and Administration of Medical Devices  Measures for the Supervision and Administration of the Production of Medical Devices  Measures for the Supervision and Administration of the Operation of Medical Devices requirement,according to Risk classification Scientific supervision,Full coverage dynamic tuning,Implement responsibilities Improve performance Principles of,Carry out hierarchical supervision over the production and operation of medical devices,Consolidate the supervision responsibility of drug regulatory departments at all levels,Establish and improve a scientific and efficient regulatory model,Strengthen the supervision and management of medical device production and operation,Ensuring the safety of people's equipment.

two Carry out hierarchical supervision of medical device production

one Implement the responsibilities of hierarchical production supervision.The State Drug Administration is responsible for guiding and inspecting the hierarchical supervision of the production of medical devices nationwide,Formulate the list of key supervised varieties for medical device production province Autonomous Region The drug regulatory department of the municipality directly under the Central Government shall be responsible for formulating the list of key regulatory varieties for the production of medical devices in its administrative region,Organize and implement hierarchical supervision of medical device production The department in charge of drug supervision and administration at the level of a city divided into districts shall be responsible for the specific work of hierarchical supervision of the production of Class I medical devices in its administrative region according to its duties.

two Determine the list of key supervised varieties in combination with the actual situation.The State Drug Administration formulates and dynamically adjusts the list of key regulatory varieties for medical device production according to the risk degree of medical device products See attachment1  province Autonomous Region The drug regulatory department of the municipality directly under the Central Government shall comprehensively analyze the registered quantity of similar products in its administrative region Market share Factors such as overall level of production quality management and risk consultation,Supplement the catalogue formulated by the State Drug Administration,Determine and dynamically adjust the list of key regulatory varieties of medical device production in this administrative region.

For medical device registrants commissioned to produce cross regional medical devices,By the province where the registrant is located Autonomous Region The drug regulatory department of the municipality directly under the Central Government shall be responsible for studying and determining whether its products are included in the list of key regulatory varieties for the production of medical devices in its administrative region.

three  We will formulate detailed regulations on hierarchical supervision. Drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall formulate and distribute detailed regulations on hierarchical supervision of medical device production and clarify the principle of classification of supervision levels based on the industrial development, quality management status of enterprises and the allocation of supervision resources in their respective administrative regions. As well as the forms, frequencies and coverage of supervision and inspection of medical device registrants and filers and entrusted manufacturers at different regulatory levels.

The classification of regulatory levels and inspection requirements can be based on the following principles:

Enterprises with a high degree of risk shall be subject to four-level supervision, mainly including those producing the listed products of key varieties under supervision in the administrative region, and those enterprises with poor operation of the quality management system and serious bad supervision and credit records;

Three levels of supervision shall be carried out on enterprises with a high degree of risk, mainly including those producing the third class of medical devices except for the list of key regulated varieties in the administrative region, as well as those enterprises with poor quality management system and bad supervision and credit records;

Second level supervision shall be carried out on enterprises with a general degree of risk, mainly including enterprises producing the second type of medical devices in addition to the list of key supervised varieties in the administrative region;

The enterprises with a low degree of risk shall be subject to first-level supervision, mainly including those producing first-class medical devices.

Where more than one level of supervision is involved, the highest level of supervision shall be applied.

In general, for enterprises that implement four-level supervision, the whole project shall be inspected no less than once a year; For the implementation of three-level supervision, the inspection shall be conducted at least once a year, including the whole project inspection at least once every two years; Where secondary supervision is carried out, the inspection shall be made at least once every two years in principle; A year in principle to the implementing regulation, randomly chosen more than 25% of the enterprises within their respective administrative areas, conducting supervision and inspection and the new class I medical devices production enterprises in production for record within 3 months from the date of the on-site inspection, if necessary for production address change or increase the scope of the site verification to the first kind of medical device manufacturing enterprise. Supervision and inspection can be combined with product registration system verification, production license change or continuation of on-site verification, etc., to improve the efficiency of supervision.

The whole item inspection refers to the inspection covering all applicable items carried out by the drug regulatory department on the regulated objects in accordance with the production quality management norms of medical devices and the corresponding appendices. The whole project inspection carried out on the registrant and recordholder of the entrusted manufacturer of medical devices shall include the inspection of the corresponding production activities of the entrusted manufacturer.

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