Recently, the General Affairs Department of the State Food and Drug Administration publicly solicited opinions on the “Opinions on Strengthening the Classified Supervision of Medical Device Production and Operations (Draft for Comments)” (hereinafter referred to as the “Opinions”). The deadline for feedback is June 19, 2022.
New national-level regulations are released and will come into effect on January 1, 2023
The State Food and Drug Administration released the latest draft for comments, which states that starting from January 1, 2023, the new version of the “Opinions on Strengthening the Classified Supervision of the Production and Operation of Medical Devices” will be implemented and the original version will be abolished.
The drafting instructions pointed out that my country’s current regulations on hierarchical supervision of production and operations were formulated in 2014 and 2015 respectively, and are no longer fully adapted to the new regulatory situation and new requirements.
Therefore, in order to further implement the newly revised “Regulations on the Supervision and Administration of Medical Devices” (hereinafter referred to as the “Regulations”), “Measures for the Supervision and Administration of the Production of Medical Devices” (hereinafter referred to as the “Production Measures”), and “Measures for the Supervision and Administration of Medical Device Operations” (hereinafter referred to as the “Operation Measures”), and strengthen the supervision of medical device production and operation, the Device Supervision Department of the State Food and Drug Administration organized a revision of the current regulations and formed this Opinion.
131 types of medical devices are included in key surveillance
The main changes in the “Opinions” are:
The first is to modify the hierarchical supervision regulations into guiding opinions. Instead of making unified regulations on the division of regulatory levels, frequency of inspections and coverage rates, local regulatory authorities will be given guidance, highlighting the leading role of provincial drug regulatory departments and the responsible drug regulatory departments at the districted municipal level.
The second is to streamline and adjust the key regulatory catalog. After revision, the “Opinions” included 84 types of medical devices such as hemodialysis equipment, imaging catheters, and guidance catheters into the catalog of key production supervision varieties; 47 types of medical devices, including anesthesia puncture kits, blood bags, and infusion sets, were included in the catalog of key production supervision varieties.
<Catalogue of key regulated varieties of medical device production>
<Catalogue of key regulated varieties of medical device business>
The third is to scientifically strengthen supervision and management. The principle of dividing the supervision levels and inspection requirements of operating enterprises will be increased from three-level supervision to four-level supervision, and scientific supervision and management will be strengthened. Business enterprises that “specially provide storage and transportation services for other medical device registrants, record-filers, and production and operation enterprises” and key inspection enterprises determined through risk consultation will be implemented as the enterprises with the highest risk level for four-level supervision. The departments responsible for drug supervision and management at the districted municipal level will organize inspections no less than twice a year, including no less than one inspection of all items.
For retail enterprises of contact lenses and protective products, the frequency of inspections can be determined according to regulatory needs; the random selection ratio of enterprises subject to first-level supervision will be increased from 30% to one-third.
It has added requirements for operating companies that add warehouses in other places, companies that operate products selected for centralized mass procurement by the state, and companies that operate products for epidemic prevention and control to increase the level of supervision as appropriate, and strengthen supervision in a targeted manner.
The fourth is to introduce the concept of credit supervision. Four levels of supervision will be implemented for registrants and recorders with poor quality management systems and serious bad credit records, and entrusted production companies; three levels of supervision will be implemented for operating companies that were subject to administrative penalties or had bad credit records in the previous year. For companies with good quality management status and regulatory credit status over a long period of time, the regulatory level will also be lowered as appropriate.
The “Opinions” clarify that registrants and entrusted production companies with poor quality management system operation and serious bad credit records will be subject to four levels of supervision, and operating companies that were subject to administrative penalties or bad credit records in the previous year will be subject to three levels of supervision; for companies with long-term quality management status and regulatory credit status, the supervision level can be lowered as appropriate.
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