Post-market Surveillance under MDR & USA
Post-market surveillance (PMS) was first discussed by defunct Glob...
Trend reporting in IVDR context and Requirements
Manufacturers of devices, made available on the Union market, othe...
Medical Devices – USA/Europe Regulatory Updates Roundup, Apr 2022
EUROPE (EU) | USA (FDA) | ROW – BRAZIL (ANVISA)
EUROPE (EU) ...
Medical Devices – Asia Regulatory Updates Roundup, Apr 2022
INDIA (CDSCO) | PAKISTAN (DRAP) | CHINA (NMPA) | MALAYSIA (MDA) | ...
Generics – Labeling content management
While brand name drug refers to the name giving by the producing c...
