Blogs
Pharma/Biotech – USA, Europe Re…
USA
FDA Publishes Two Final Guidance’s on Technical Specifications for Clinical Data
The FDA pu…
Modifications to Medical Device Regis…
In August 2023, the COFEPRIS, the Mexican Regulatory body in charge of the regulation of Medical Devi…
ANVISA Updates Importation Law: Key C…
The introduction of RDC 751/2022 was significant for the Medical Device industry because it revised B…
Medical Devices-USA/Europe Regulatory…
USA
Guiding Principles on Predetermined Change Control Plans for Machine Learning-Enabled Medical …
Swissmedic Device/IVD Database Key Dates
Swissmedic now handles registration of economic operators, medical devices and in vitro dia…
Consumer Health-USA/Europe/Asia/ROW R…
USA
Canada
Three New Food Enzymes Granted Approvals
On October 11, 2023, Health Canada unvei…
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