Notice of the General Department of the State Food and Drug Administration on printing and distributing the inspection plan of national sampling products for medical devices in 2022

Yjzxg [2022] No. 15

The drug administration of all provinces, autonomous regions, municipalities directly under the central government and Xinjiang production and Construction Corps, China food and Drug Control Institute and relevant inspection institutions:

According to the notice of the General Department of the State Food and Drug Administration on carrying out the random inspection and inspection of the quality of national medical devices in 2022 (yjzxg [2021] No. 108), the inspection scheme of national random inspection products of medical devices in 2022 is hereby printed and distributed to you, and the relevant requirements are notified as follows:

1、 Inspection requirements

The drug administration of all provinces, autonomous regions, municipalities directly under the central government and Xinjiang production and Construction Corps (hereinafter referred to as the Provincial Bureau) CFDA shall organize relevant inspection institutions to carry out inspection in accordance with the mandatory standards for medical devices and the registered or filed product technical requirements (registered product standards) in accordance with the 2022 national random inspection scheme for medical devices (Annex 1).

2、 Re inspection requirements

The re inspection acceptance Department of the national supervision and sampling inspection in 2022 is the provincial drug supervision and administration department where the medical device registrant, filer or import product agent is located. The re inspection application for the same inspection report can only be handled once. The provincial drug regulatory department accepting the re inspection application shall determine the re inspection institution to conduct the re inspection according to the list of national medical device sampling and re inspection institutions in 2022 (Annex 2), and the re inspection institution shall not refuse. If it is specified in the inspection plan as random inspection for risk monitoring, it shall not be rechecked.

Since 2022, the inspection institutions included in the list of re inspection institutions shall continue to maintain the inspection capacity and inspection qualification of their corresponding varieties and items, and are obliged to undertake the re inspection work in the law enforcement work of Provincial sampling inspection and local drug supervision and administration departments. The re inspection institution shall take the initiative to disclose the contact information of the re inspection, so as to facilitate the re inspection work. The specific requirements for re inspection are detailed in the national requirements for random inspection and re inspection of medical devices in 2022 (Annex 3).

If the party concerned disagrees with the inspection conclusion and fails to pass the re inspection and verification, he 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 working procedures for random inspection and inspection of national medical device quality (yjzxg [2021] No. 46).

3、 Other requirements

The medical device registrant, filer and sampled unit shall take risk control measures immediately after receiving the product non conformance report. The drug regulatory department shall organize investigation and disposal in a timely manner. If it meets the conditions for filing a case, it shall file a case for investigation and punishment in a timely manner; Those suspected of committing a crime shall be transferred to judicial organs according to law.

enclosure:

1. 2022 national random inspection scheme for medical devices

2. List of national medical device sampling and re inspection institutions in 2022

3. Requirements for sampling and re inspection of national medical devices in 2022

File link: https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjylqx/20220222164656199.html

Comprehensive Department of the State Food and Drug Administration

February 21, 2022

Source: State Food and Drug Administration