On March 31, the General Affairs Department of the State Food and Drug Administration issued the “Notice on Issuing the National Medical Device Sampling Product Inspection Plan in 2023”, proposing relevant requirements for national medical device sampling variety inspection and re-inspection.
According to the “Notice of the Comprehensive Department of the State Food and Drug Administration on Carrying out National Medical Device Quality Spot Inspections in 2023” (Food and Drug Administration Comprehensive Equipment Management [2023] No. 5), the 2023 National Medical Device Sampling Product Inspection Plan is now issued to you, please organize and implement it. The relevant requirements are now notified as follows:
1. Inspection work requirements
The Drug Supervision and Administration Bureau of all provinces, autonomous regions, municipalities directly under the Central Government, and the Xinjiang Production and Construction Corps, and the China Institute of Food and Drug Control shall, in accordance with the 2023 National Medical Device Sampling Variety Inspection Plan (see Attachment 1), organize relevant inspection agencies to carry out inspection work in accordance with the mandatory standards for medical devices and the technical requirements of registered or filed products.
2. Re-inspection work requirements
The re-inspection acceptance department for national supervisory sampling inspections in 2023 shall be the provincial drug regulatory department where the medical device registrant or imported product agent is located. The re-inspection application for the same inspection report can 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 2023 National Medical Device Sampling and Re-inspection Institutions List (see Appendix 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.
Inspection institutions included in the list of re-inspection institutions shall continue to maintain their inspection capabilities and qualifications for corresponding varieties and projects, and are 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. Please see Appendix 3 for details of the national medical device sampling and re-inspection work requirements in 2023.
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
The medical device registrant and the sampled unit shall immediately take risk control measures after receiving the report 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.
Click on the original link to view the attachment: Notice from the General Affairs Department of the State Food and Drug Administration on the issuance of the 2023 National Medical Device Sampling Product Inspection Plan