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ICH Guideline E8 (R1) on General Cons…
Clinical studies of medicinal products are conducted to provide information that can ultimately impro…
Switch of the legal status of a medic…
Principles and procedures for a ‘switch’ of the legal status of a medicinal product from prescription…
Registration of Drug-device Combinati…
NMPA Notice on Matters Concerning the Registration of Drug-device Combination Products
With the vi…
Medical Devices – USA/Europe Re…
EUROPE
1. Clarification on “first certification for that type of device” and corresponding procedu…
Medical Devices-Asia Regulatory Updat…
China (NMDA)
1. 2th China International Medical Device Regulatory Forum held in Wuhan Spon…
China – Notice on registration …
On March 5, 2021, the State Food and Drug Administration of China issued an announcement on the Regis…
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