Published on
Last updated on
New List of Class III Medical Devices Requiring Clinical Trials
On September 14, the CMDE (Center for Medical Device Evaluation) announced an updated list of class III medical devices requiring clinical trials replacing the list last released in 2014.
The 2020 amended edition added heart stents and internal fixation devices to the list of devices requiring clinical trials in China with effect from September 14 onwards.
By Jacky Li. Contact Cisema if you would like to learn more.
Related News
Malaysia Introduces New e-IFU & Digital Labelling Guidance for Medical Devices
Malaysia’s MDA publishes the 7th edition of guidance on medical device labelling, with new e-labelling, e-IFU, and accessibility requirements
Vietnam Authorities Step Up Cosmetic Recalls as Enforcement Tightens
Vietnam’s Drug Administration (DAV) is stepping up cosmetic product recalls as post-market surveillance tightens.
BPOM Clarifies Indonesia–US Trade Agreement Impact on Pharmaceutical Regulation
BPOM confirms pharmaceutical authorization, GMP oversight, and regulatory authority remain unchanged under the Indonesia–US trade agreement.