By Stewart Eisenhart, Emergo Group

Chinese medical device market regulators have published long-awaited updates to medical device as well as in vitro diagnostic device and labeling requirements that will go into force October 1, 2014.

First, China Food and Drug Administration (CFDA) Administrative Order No. 4 (link in Chinese) encompasses multiple areas of medical device registration, in-country representation, clinical trial requirements and related submission procedures.

Regulators have also issued Administrative Order No. 5 (link in Chinese) regarding registration and approval of IVD products in China. The order will implement a three-tier, risk-based classification system (Class I, II and III), as well as authorized representation, clinical trial and other requirements similar to those in Order 4 for medical devices.

Finally, Administrative Order No. 6 (link in Chinese) covers medical device indications for use (IFUs) and labeling requirements.

Emergo Group’s Beijing office is conducting a thorough analysis of the new CFDA regulations to determine their impact for medical device and IVD manufacturers selling in China; additional details are forthcoming.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.