Generics – Labeling content management
While brand name drug refers to the name giving by the producing c...
IVDR: Latest plan of action from MDCG
Set A – Essential Actions No.TopicActionTimelineStatus 1Contingenc...
Medical Devices – USA/Europe Regulatory Updates Roundup, Mar 2022
EUROPE (EU), USA (FDA)
EUROPE (EU) SIQ Ljubljana became a notified...
Medical Devices – Asia Regulatory Updates Roundup, Mar 2022
INDIA (CDSCO)| PAKISTAN (DRAP) | PHILIPPINES (FDA) | CHINA (NMPA) ...
A Guide for Medical Device Organizations in Clinical Evaluation Report (CER) Submission
Launching a new medical device in the market always need a Clinica...
8 key Questions & Responses on Clinical Investigation under EU MDR
1: Difference between the performance, clinical performance and cl...
