Synergus

Announcement from SFDA (China)

Pressmeddelande   •   Sep 21, 2008 10:11 CEST

Chinese SFDA announced today to cease a few official notices concerning medical devices. They were:


SFDA 1996 No.70 and its attachments; Notice on implementation of market access examination for medical devices
SFDA 1997 No. 280; Notice on regulation of medical device clinical study
SFDA 2001 No.130; Notice on Regulation of registration type testing for imported medical devices
SFDA 2001 No. 478; Notice on supplements of implementing the regulation for imported and Class 3 medical devices
SFDA 2002 No. 259 Notice on Supplement requirements for medical device registration No.1
SFDA 2003 No. 119; Notice on Supplement requirements for medical device registration No.2


Please note these impact only the official notices, not the regulation itself. The impact on medical device registration in China will be updated in our conference on Chinese medical device regulation and registration, Oct. 23-4, Copenhagen.

Disclaim: the English translation of the document titles are unofficial and for reference only. Please check with SFDA's official web site: www.sfda.gov.cn