Entry into force on June 1st 2014, revised regulations for Medical Devices in China

9 May, 2014

The China food and Drug Administration (CFDA) revised the regulations for Medical Devices. These new regulations will impact the medical device classification approach. The registration process will differ from the current system as well as the certificate validities. Changes will also affect the Clinical trials.

If you want to figure out how the new rules affect your registrations in China get in touch!

Contact person
Isabelle Lang-Zwosta
Group Leader Health Care
Tel   +49 621-400460-14
Fax  +49 621-400460-10
Send email

Business Units: 
Dr. Xiaohua He Managing Director
+86 21 6199 2001 +86 21 6192 4143 send mail