New Chinese Medical Device, IVD Regulations Take Effect in October 2014
Content provided by Emergo Group, a medical device regulatory affairs and quality assurance consulting firm with offices worldwide.
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 1 October 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.