Hubei Province Medical Device Quality Announcement (Issue 1, 2022)

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 Drug Administration organized quality supervision and sampling of 594 batches of products including medical masks. The results of the random inspection are hereby announced as follows:

1. There are 579 batches of medical device products that all meet the standard requirements (see Annex 1 for details).

2. There are 15 batches of medical device products whose sampling items do not meet the standard requirements (see Annex 2 for details).

3. For the medical device products found in the above-mentioned random inspections that do not meet the standards, the Hubei Provincial Drug Administration has required the drug supervision and administration department where the sampling unit is located to conduct inspections on the relevant units in accordance with the "Regulations on the Supervision and Administration of Medical Devices" and other regulations and regulations. Investigate and handle, urge enterprises to find out the reasons, formulate rectification measures and rectify within a time limit. Corresponding recall and corrective measures must be taken for the unqualified products that have been listed to ensure the quality, safety and effectiveness of the products. Those involving enterprises from other provinces have been notified to the local drug regulatory authorities.

Attachment: 1. 2021 Hubei Province Medical Device Sampling Inspection List of Products Compliant with the Standards

      2.2021 Hubei Province Medical Device Sampling Inspection List of Products Not Complying with the Standards

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2021年湖北省医疗器械抽验不符合标准规定产品名单