The QMN Weekly Bulletin
Quality / Medical Devices / Regulatory Affairs

China Issues 90 Standards to Raise Device Quality

June 5, 2015

The China Food and Drug Administration has issued 90 industry standards — 14 mandatory and 76 recommended — covering implants for surgery, medical electrical equipment, in vitro diagnostic reagents and dentistry.

The standards will improve the medical device standards system, help improve the quality of medical devices and promote the sound development of the medical device industry, the CFDA said in an April announcement.

The 14 mandatory standards will take effect Jan. 1, 2017, while the 76 recommended standards will take effect Jan. 1, 2016, says John Balzano, special counsel for Covington & Burling’s food and drug practice group. The standards are part of the CFDA’s ongoing device regulatory reform, which aims to increase the quality of devices in the Chinese market, he said.

Jack Wong, director of regulatory affairs for Asia Pacific in Terumo BCT’s Singapore branch, says it is difficult to describe the impact to industry, but recommends that companies identify any standards related to their products to determine whether they are in compliance. China’s device regulations were adopted in March 2014 and took effect Oct. 1.

Are you planning to market your medical devices in China? Then you need the Latest Chinese Guidebook for Application & Approval of Imported Medical Device Registration. The report does more than translate the text of China’s new medical device rules. It translates how to work with newly reorganized regulatory authorities to demonstrate the safety and effectiveness of your device so you can win — and keep — China’s approval to market your products.