Mexico’s Cofepris releases provision for ventilator requirements during COVID-19 Pandemic.
On April 6, 2020 Mexico’s Cofepris released provisions on the minimum requirements for ventilators to receive approval during the COVID-19 pandemic.
Brazil’s Anvisa Releases New Technical Note on the conduct of clinical trials during the COVID-19 pandemic.
Brazil’s Anvisa issues technical note that gathers the latest guidelines on the conduct of clinical trials in the face of the new coronavirus pandemic.
Registration of a New Molecule in Mexico
In Mexico, manufacturers who seek market authorization (Sanitary Registration) for their new drug must first request approval of their products as new molecules from the New Molecules Committee (NMC) of COFEPRIS
ANVISA -RDC 305/2019- Regulation for Custom-Made Medical Devices
On October 2019, Anvisa published its formal regulations for custom-made medical devices “RDC 305/2019. “