China Raises Bar with 186 New Industry Standards on Medical Devices

China’s Food and Drug Administration issued 186 new standards for medical devices, 42 of which are mandatory industry requirements and 144 recommended standards.

Standards include new CFDA submission fees, clinical trial and evaluation reports, GMPs, medical device reporting and monitoring requirements.

Before seeking market authorization in China, manufacturers need to do two things: designate a local registered authorized representative and assign the product into one of three regulatory classes.

The medical device market is one of China’s fastest growing industry sectors. Within the last decade the market had an average growth rate of 20 percent, becoming the second-largest medical device market in the world, according to the International Trade Administration.

China’s device market and regulatory requirements have been going through infinite revisions to accommodate growing pains.

In 2013 the CFDA released 107 medical device standards, specifically revising guidance documents to help medical device manufacturers with the application and approval process.  

Although new regulations and guidance documents provide more structure to the application process in China, the process for gaining access to the market can be lengthy and complex.

In 2014, the CDFA worked to enforce existing medical devices regulations to continue to weed out weaker companies that could not reach the bar. Those enforcements focused on: false information in registration applications, manufacturing violations, illegal distribution, exaggerated advertising claims, and use of unregistered devices. — Joya Patel