Hubei Province Medical Device Quality Announcement (Issue 1, 2024)

In order to strengthen the quality supervision and management of medical devices and ensure the safety and effectiveness of medical device products used by the public, the Provincial Food and Drug Administration organized quality supervision and random inspections of 899 batches of products such as disposable sterile syringes. The results of the random inspections are now announced as follows:

1. There are 886 batches of medical device products that are all in compliance with the standards for the sampled items.

2. There are 13 batches of medical device products that were randomly inspected and did not meet the standards.

3. For the medical device products found in the above-mentioned random inspections that do not meet the standards, the Hubei Provincial Food and Drug Administration has required the drug regulatory department where the sampled unit is located to conduct inspections on the relevant units in accordance with the requirements of the "Regulations on the Supervision and Administration of Medical Devices" and other laws and regulations. Investigate and handle, urge enterprises to identify causes, formulate corrective measures and make corrections within a time limit. Take corresponding recall and corrective measures for unqualified products that have been put on the market to ensure the quality, safety and effectiveness of the products. If companies from other provinces are involved, the local drug regulatory authorities have been notified.

Hubei Provincial Food and Drug Administration

February 27, 2024