Published on
Last updated on
New Clinical Trial Exemption List
On 30.09.2018, the NMPA published a revised “Clinical Trial Exemption List for Medical Devices and IVDs”, which was immediately implemented (NMPA No. 94-2018). 63 Class II and 21 Class III medical devices, 246 Class II and 31 Class III IVDs were added. The new clinic trial exemption list now contains a total of 855 medical devices and 393 IVDs.
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.