The National Drug Administration has issued guidance on strengthening the hierarchical supervision of medical device production and operation
Release Time:
2022-09-09
On September 9th, the National Drug Administration issued the "Guiding Opinions on Strengthening the Grading Supervision of Medical Device Production and Operation" (hereinafter referred to as the "Guiding Opinions"), guiding drug regulatory departments in various regions to better carry out the supervision of medical device production and operation under the medical device registration system. The Guiding Opinions will come into effect from January 1, 2023
The Guiding Opinions require provincial-level drug supervision and management departments and district level municipal drug supervision and management departments to combine industrial development and regulatory reality, leverage regulatory resource efficiency, and formulate detailed requirements for production and operation hierarchical supervision that are in line with the actual situation of the local area; Risk grading, scientific supervision, comprehensive coverage, dynamic adjustment, implementation of responsibilities, and improvement of efficiency; The principle of organizing and implementing hierarchical supervision of the production and operation of medical devices
The Guiding Opinions propose the principles and inspection requirements for the classification of regulatory levels for medical device production and operation enterprises. The drug regulatory department can divide medical device enterprises into four regulatory levels based on risk, and implement corresponding regulatory measures for enterprises at different regulatory levels. For enterprises with good regulatory credit status for a long time, the regulatory level can be lowered as appropriate; For medical device registrants who engage in cross regional commissioned production, commissioned production enterprises that only engage in commissioned production, and operating enterprises that have added warehouses in other places, the regulatory level should be appropriately raised. Supervision and inspection of medical device production enterprises shall be carried out through non pre notification methods, and surprise supervision and inspection shall be carried out on operating enterprises
The Guiding Opinions require drug regulatory departments at all levels to further strengthen overall coordination and establish a sound cross regional and cross level collaborative regulatory mechanism; Continuously strengthen the handling of problems, and promptly handle problems found during inspections in strict accordance with regulations and other requirements; Continuously strengthen regulatory capacity building, enrich regulatory resources, effectively carry out quality supervision of medical devices throughout their entire lifecycle, and ensure the safety of people's use of equipment
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