China FDA Proposes Review Process for High-Priority Medical Device Registration

Chinese medical device regulators are seeking comment on a draft proposal for determining which devices qualify for the country’s high-priority review program, and in what order.

The China Food and Drug Administration (CFDA) has targeted domestic Class II devices and imported Class II and III devices in the proposal (link in Chinese); the regulator seeks to establish three review groups for determining which devices qualify for high-priority reviews.

Group 1 devices would include products that are part of China’s National Science and Technology Major Project or the National Key Technologies Research & Design Program. Reviews of Group 1 devices to determine whether they qualify for high-priority registration would take five business days.

Group 2 devices would include the following types of products:

• Devices that diagnose or treat rare disorders and show significant clinical advantages over existing treatments
• Devices that diagnose or treat malignant tumors and show significant clinical advantage
• Devices to diagnose or treat diseases that afflict older populations or children and for which no effective treatment or diagnosis methods currently exist
• Devices that are considered urgently needed and that have no existing predicates available on the Chinese market

The CFDA would convene expert panels on a monthly basis to determine which Group 2 devices qualify for high-priority review and which should undergo normal premarket review.

Group 3 devices would include other products that should be evaluated as high priority.

The CFDA first announced its high-priority review pathway in 2014 as a way to introduce innovative medical technologies into the Chinese market faster than through standard registration. While the high-priority pathway does not necessarily curtail any requirements of the standard CFDA registration process, it may nonetheless speed up review timeframes for qualifying manufacturers.

Emergo consultants in China will provide updates on the CFDA proposal in the near future.