China issues a further 90 industry standards for medical devices

03 July 2015

Alison Wong, Dr David Pountney

Demand for medical devices is increasing in China, especially in the wealthier urban areas. With an estimated value of over $17-billion the Chinese medical device market is the world's fourth largest with many opportunities for overseas companies. In an effort to ensure the continued safety and effectiveness of devices, there have been many recent changes and revisions to the Chinese regulatory framework for certification by the China Food and Drug Administration (CFDA).

In April 2015 the CFDA issued a further 90 industrial standards for medical devices. Of these, 14 are to be mandatory standards concerning inter alia haemodialysis and laser corneal refractive therapy equipment and will come into effect on 01 January 2017. The remaining 76 recommended industry standards concern implants for surgery, medical electrical equipment, in vitro diagnostic reagents, and equipment for dentistry and will come into effect on 01 January 2016. These new 90 standards are in addition to the 120 industry standards already announced in July 2014 and bring the total number of medical device standards to over 700.

Although most of the guidance is similar or equivalent to the European harmonised standards, careful attention must be paid to the version adopted and any local variations. Any non-conformance to a relevant Chinese standard could hinder regulatory approval. The announcement of these additional industrial standards will further improve the quality and safety of medical devices in China and promote the development of the Chinese medical device industry. As China's medical device market rapidly develops it is expected that further new standards and announcements will be issued by the CFDA.

This article is part of the International Life Sciences Update for July 2015.



Alison Wong

China and Hong Kong

Call me on: +852 2248 6000