The CFDA doesn’t slow down for Christmas… At the end of 2017 China’s regulator made a rapid series of announcements proposing major regulatory changes for Medical Devices and IVDs.
• 31 October a draft amendment to Order 650 which will abolish mandatory in China type testing
• 30 November proposal for acceptance of international clinical data
• 28 December announcement of a new international manufacturer audit program
All of this following closely after announcements of a complete rewriting of the CFDA device classification catalogue, process changes to streamline clinical trial approvals
and extensions to clinical trial exemption lists including substantial numbers of new IVD exemptions.
What to make of it all? These changes should speed things up dramatically in China, but as always, the devil is in the detail. We take a look at the proposed changes, and how they will affect doing business in China in 2018.Download Slides Contact Us