China medical device QA/RA blog

News and commentary on regulatory changes.

Device Recall Regulations Set to Take Effect in China

China’s State Food and Drug Administration (SFDA) will implement new medical device recall regulations on July 1.

The Provisions for Medical Device Recall (interim) include 38 articles covering the supervisory system for device recalls, classification and categories of recalls as well as legal liability issues. The provisions are intended to hew closely to international conventions regarding core issues, and incorporate procedures already put in place for China’s drug recall system. Also included in the provisions are more specialized regulations to better target issues surrounding medical devices.

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