Some Medical Devices Exempted from Clinical Trials

359 Class II and III medical devices exempted from clinical trials for registration in China. 

NMPA (China Food and Drug Administration) released announcement 133, 2016 on 27.9.2016 containing a list of medical devices in Class II and III which are lo longer required to undergo clinical trials for registration in China. The list consists of 267 Class II devices and 92 Class III devices. The total number of devices exempted from clinical trials is 755 in Class II and 171 in Class III.

More comprehensive application documents required for NMPA registration of medical devices in China

NMPA announcement 178, 2016 published on 29.9.2016 contains new regulations concerning registration documents. As usual, applicants have to submit one set of original applications, plus, additionally, one set of copies and a set of documents in electronic form as of 1.11.2016.

Further information on the above topics can be obtained from:

Cisema GmbH
Tel.: +49 89 4161 7389 – 00
Fax: +49 89 7484 9956
info@cisema.de
www.cisema.com