New Chinese Medical Device, IVD Regulations Take Effect in October 2014

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 colleagues in China are conducting a thorough analysis of the new CFDA regulations to determine their impact for medical device and IVD manufacturers selling in China; based on a preliminary review of the new orders shows the following:

Item Old Regulation New Regulation Possible Result
Class I Medical Device Registration Filing Shorter approval timeframes for Class I devices
Certificate renewal  Every 4 years Every 5 years Longer validity dates
On-site inspections Not required May be required More emphasis on quality management system compliance
Clinical Trials Not required May be required More expenses and longer timeframes for CFDA approval
CFDA Fees Not required May be required More expenses for obtaining CFDA approval
Legal Agent and After Sales Agent Both required Only Legal Agent required Legal Agent has more responsibility
IVD Registration Testing and clinical trials can proceed in parallel Testing must occur before clinical trials Longer timeframe for IVD registration

Stewart Eisenhart

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