China Proposes Broader Criteria, Higher Penalties for Device Recalls

China FDA is proposing expanded requirements for medical device recalls and higher fines for manufacturers that fail to issue recalls.

The proposed rules change the standards for when a recall would be required. Under the new rules, a recall would be required for devices that do not comply with the technical requirements that were filed as part of the products’ premarket approval application.

Current rules require manufacturers to recall devices that present an “unreasonable risk of harm to human health and life safety in the course of normal use,” the law firm Covington & Burling said in a note to clients. — Tamra Sami