On September 18,2020 Brazil’s Anvisa published the RDC no. 423/2020 which deals with the extinction of the registration and migration of medical devices of risk class II to the notification regime.
China’s CDE publishes draft listing 117 drugs that will be exempt from BE studies.
Brazil’s Anvisa new standards require companies to warn about formula changes in products subject to health surveillance.
China’s NMPA updates and address some common issues faced by the Marketing Authorization Holders to submit PRER report.
NMPA announces a new revised Drug Administration Law of the People’s Republic of China effective since Dec 1, 2019.
From September,1st 2020 COFEPRIS establishes the request for appointments will be via the internet and face-to-face attention in the CIS for the entry of priority formalities.