New Requirements Could Hinder Devices in China

Changes proposed by China’s State Food and Drug Administration (SFDA) to strengthen device regulation could result in unnecessary burdens on industry and delay or interrupt access to new technologies, an industry group says.

AdvaMed is taking issue with sections of the proposed regulation relating to reregistration of devices and products that have had minor changes.

The proposed regulation, discussed in a public consultation released last month, exempts products with no changes from type testing upon reregistration. But devices that have had minor improvements over their four-year registration period would be subject to type testing — even if those changes do not affect the safety or efficacy of the device.

“We are concerned that only a small number of products will have had ‘no change’ and thus be exempt from type testing upon reregistration,” AdvaMed says in its draft response to the consultation.

Incremental changes are an accepted part of the improvement process of high-technology products, the group adds, noting that neither the U.S. nor Europe requires prior review for changes that do not affect safety or efficacy. It is pressing the SFDA to do likewise.

AdvaMed also urges the SFDA to rethink provisions that could require the redesign and reregistration of devices when new mandatory standards are issued. The SFDA recently issued 73 industry standards for medical devices, including 33 mandatory standards and 40 recommended standards, that will take effect next year.