On February 22, the State Food and Drug Administration website issued a notice on the issuance of the 2022 National Medical Device Sampling Product Inspection Plan. This year’s medical device sampling includes 60 products such as electronic endoscopes, hollow fiber dialyzers, and sodium hyaluronate gel for injection. The full text is below.
The Drug Supervision and Administration Bureau of all provinces, autonomous regions, municipalities directly under the Central Government and Xinjiang Production and Construction Corps, China Institute of Food and Drug Control, and relevant inspection agencies:
According to the “Notice of the General Affairs Department of the State Food and Drug Administration on Carrying out the National Medical Device Quality Spot Inspection in 2022” (Food and Drug Administration Comprehensive Equipment Management [2021] No. 108), the 2022 National Medical Device Sampling Product Inspection Plan is now issued to you, and the relevant requirements are notified as follows:
1. Inspection work requirements
All provinces, autonomous regions, municipalities directly under the Central Government and the Xinjiang Production and Construction Corps Drug Supervision and Administration Bureau (hereinafter referred to as the provincial bureau) and the China Institute of Food and Drug Control shall organize relevant inspection agencies to carry out inspection work in accordance with the 2022 National Medical Device Sampling Variety Inspection Plan (Annex 1) in accordance with the mandatory standards for medical devices and the technical requirements for registered or filed products (registered product standards).
2. Re-inspection work requirements
The re-inspection acceptance department for national supervisory sampling inspections in 2022 is the provincial drug regulatory department where the medical device registrant, filing person or imported product agent is located. The re-inspection application for the same inspection report will only be processed once. The provincial drug regulatory department that accepts the re-inspection application shall determine the re-inspection institution to conduct re-inspection based on the 2022 National Medical Device Sampling and Re-inspection Institutions List (Annex 2), and the re-inspection institution shall not refuse. If the inspection plan is clearly for risk monitoring and sampling, re-inspection will not be allowed.
Starting from 2022, inspection institutions included in the list of re-inspection institutions shall continue to maintain their inspection capabilities and inspection qualifications for corresponding varieties and projects, and shall be obliged to undertake re-inspection work during provincial sampling inspections and law enforcement work of local drug regulatory authorities. The re-inspection agency should take the initiative to disclose the re-inspection contact information to facilitate the re-inspection work. For specific requirements on re-inspection work, please refer to the 2022 National Medical Device Sampling Re-inspection Work Requirements (Annex 3).
If the party concerned has objections to the inspection conclusion and cannot pass the re-inspection verification, he or she may submit a written application for objection appeal to the local provincial drug regulatory department. The specific time limit and process shall be handled in accordance with the relevant objection appeal provisions in the “National Medical Device Quality Spot Inspection Work Procedure” (Drug Supervision Comprehensive Equipment Administration [2021] No. 46).
3. Other requirements
Medical device registrants, recorders and sampled units should immediately take risk control measures after receiving reports of product non-compliance. The drug supervision and administration department shall promptly organize investigation and disposal. If the conditions for filing a case are met, the case shall be filed and investigated in a timely manner; if a crime is suspected, the case shall be transferred to the judicial authority in accordance with the law.