China’s FDA Issues Notice on Device Classification, Rule on Generic Naming

China’s FDA has unveiled plans to assemble an expert committee to review and discuss medical device classification, as well as spelling out the rules for using generic names for devices.

The agency issued a notice explaining the requirements for committee members in terms of academic and technical expertise, as well as the responsibilities of the group.

China has three classes of medical devices, and clinical trials are mostly required for Classes 2 and 3 devices, which can be waived. Class 1 requires a premarket notification only. By contrast, the U.S. registration process is more distinct between the classes, says Helen Chen, head of L.E.K. Consulting’s China life sciences practice.

“The classification of the products and the international norms can impact how CFDA classifies the products, and what it would require for product registration and ongoing reporting. This then directly ties into how quickly companies can register and launch products in China,” she tells IDDM.

Device Naming

In a separate document, the CFDA issued the medical device generic naming rule, which intended to create standards for product names so they are not misleading.

Chen explains that consumer medical devices — those typically sold in a pharmacy or specialty story — are the target of this rule. Devices used in hospitals will not be affected. “It is not unlike the truth in advertising concept in the U.S.,” she adds.

The rule, which takes effect April 1, focuses on requirements for specific generic names and provides guidance on the wording of advertisements, says Jack Wong, director of regulatory affairs for Asia Pacific in TerumoBCT’s Singapore branch.

“Companies cannot make superlative claims, and all claims need scientific justification,” he tells IDDM, adding that devicemakers should have proper internal approval processes on promotional material in place before those materials are released.

Read the classification notice www.fdanews.com/12-15-CFDA-Notice.pdf and the naming rules here: and www.fdanews.com/12-15-CFDA-Rules.pdf. — Jonathon Shacat