Anhui Province Medical Device Quality Announcement (No. 3, 2022)

In order to strengthen the supervision and management of medical device quality and ensure the safety and effectiveness of medical device products used by the public, the Anhui Provincial Drug Administration organized the supervision and random inspection of the medical device quality of medical device production, operation and user units in the administrative region. The sampling inspection information in this issue involves a total of 37 sampling units and 58 batches of products from 36 medical device manufacturers. The inspection results all meet the requirements (the relevant inspection results are only responsible for the samples). It is now announced.

The Anhui Provincial Drug Administration reminds consumers that medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials, and other similar or related items that are directly or indirectly used in the human body, including the required computer. software. When choosing a medical device, first of all, it depends on whether the main business operator has a "Medical Device Business License" and "Medical Device Business Recording Certificate"; secondly, it depends on the label and instruction of the product, whether it is marked with the medical device production license number and product registration. Please read the label and manual carefully when using it, and pay special attention to the precautions, warnings and hints in the manual. If you buy counterfeit or substandard medical devices, please call the local market supervision department in time to report and complain at 12315.

Attachment: 2022 Issue 3 Anhui Province Medical Device Quality Sampling Inspection Information (meeting requirements).xls

Anhui Provincial Drug Administration

March 16, 2022

2022 Issue 3 Anhui Province Medical Device Quality Sampling Inspection Information (Meet the Requirements)