Expert: China’s New Device Standards Will Reduce Regulatory Uncertainty

China’s new technical standards for medical devices provide much needed clarity to regulations that previously were open to different interpretations, experts said.

The 186 new standards are a tangible set of guidelines that “create consistent review standards the industry has been clamoring for,” said Helen Chen, managing director and partner at L.E.K. Consulting in Shanghai.

“CFDA is addressing the concerns raised by industry, including AdvaMed, that the lack of standards and often inconsistent interpretation by individual CFDA reviewers add complexity and opacity to an already onerous registration process,” Chen said.

The 186 new standards, 42 of which are mandatory, include standards devices need to meet, parameters for testing, rules of inspections and other technical requirements, she said (IDDM, May 9).

Device manufacturers will be mostly affected when they submit new applications and when they renew existing licenses. Chen recommends that companies retool their processes before they submit applications.

“In general, we expect that the bigger impact would come during license renewal time, where the products which no longer qualify under the new standards are withdrawn from the market,” Chen said.

Katherine Wang, partner at Ropes & Gray LLP, said the changes will also affect manufacturers’ research and development of new devices. She noted that devicemakers currently comply with mandatory industry requirements, but there have been no concrete national technical standards.

Manufacturers who fail to meet the mandatory standards face significant risk, Wang said, including “significant legal risks, confiscation of products, fines, revocation of licenses and permits.”

For manufacturers already in compliance with the mandatory standards, the technical review process will be streamlined, Chen said. If standards are not specified, manufacturers need to demonstrate specifications that would ensure safety and efficacy for CFDA approval.

As a result of the tightened standards, products registered under a lax regime with lower quality and efficacy will naturally be weeded out of the system.

Before multinational devicemakers can market their products in China, they need to designate a local registered agent and assign the product into one of three risk classes.

The mandatory industry standards will come into effect on Jan. 1, 2018 and the recommended standards become effective on Jan. 1, 2017.

Read the CDFA announcement here (in Chinese language): www.fdanews.com/05-11-16-CFDA74thAnnouncement.pdf. A link to standards of each device is here (in Chinese language): www.nifdc.org.cn/CL0823/. — Joya Patel