Decree 19 Good Manufacturing Practice In Class III Medical Device Manufacturers

Notice on the Implementation of Good
Manufacturing Practice of Medical Devices in Class
III Medical Device Manufacturers from Food and
Drug Administration
(2016 No.19)
Issued on February 5, 2016
According to Notice on the implementation of related provisions on the
Good Manufacturing Practice of Medical Devices (Notice No.15 of State
Food and Drug Administration in 2014), all Class III medical device
manufacturers shall meet the requirements of Good Manufacturing
Practice of Medical Devices since Jan.01, 2016. Additionally,
Manufacturers of sterile and implantable medical devices as well as in
vitro diagnostic reagents shall also meet the requirements of the annex of
sterile and implantable medical devices as well as in vitro diagnostic
reagents (Notices No.101, 102 and 103 of State Food and Drug
Administration in 2015).