Yi Wang (CN)

New device guidelines published in China

By Yi Wang (CN) on October 14, 2016 Posted in International

On 21 September 2016, the Department of Medical Device Supervision of the China Food and Drug Administration (CFDA) published the Guidelines to Medical Device Manufacturers for the Quality Control and Release of Finished Products (Draft for Public Comment) (the Guidelines). The comment period expired on 30 September 2016 and the final version of the Guidelines … Continue reading

Tapping into China’s medical devices industry: Ten things to know

By Yi Wang (CN) on March 15, 2016 Posted in International

Our newly released guide shares the top ten things to know about tapping into China’s medical devices industry. The guide provides an overview of the regulatory regime for medical devices in China and the top issues that foreign investors and manufacturers should consider when entering the China market.… Continue reading