Comments to CFDA on Priotized Evaluation of Medical Devices

2016-07-20 | Beijing

The Healthcare Equipment Working Group submitted comments to the CFDA on the draft "Procedures for a Prioritized Evaluation of Medical Devices"

The CFDA has proposed a regulation that certain live-saving medical devices may apply for an accererated evalution.

Part of the regulation favourize local products, for example invention made within central state research projects to which international manufacturers have no access. The Working Groups advocated equal treatment of imported products.

Evalution is just one part of the registration process. The working group hopes that the scope of the regulation could be extended to the whole registration procedure.

More information: http://www.cfda.gov.cn/WS01/CL0779/156571.html