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Oct 142 min read

MDCG Med Dev: Guidance and Templates for Conformity Assessment Bodies, Notified Bodies, Designating Authorities, and Joint Assessment Teams

The Medical Device Coordination Group (MDCG) has released its updated guidance and templates for conformity assessment bodies, notified...

Sep 92 min read

South Africa SAHPRA: eCTD Validation and Technical Screening for Renewals - Template

The South African Health Products Regulatory Authority (SAHPRA) has provided updated guidance for " ECTD Validation And Technical...

Mar 22 min read

EMA: QRD updation and Product-Information Templates Updation

The European Medicines Agency released an updated template on QRD and updated its page on "Product-information templates - Human". The...

May 9, 20231 min read

South Africa's SAPHRA: Validation Template For ECTD Variation Applications, QOA & QIS

Recently (05 May 2023) the South African Health Products Regulatory Authority (SAPHRA) released the template "Validation Template For...

Mar 11, 20231 min read

Malaysia NPRA: Declaration of WorldWide Registration Status for Generic Medicines in QUEST System

Yesterday (10 March 2023) released an updated word template that shall declare their worldwide registration status (WWRS) for all new...

May 28, 20211 min read

MDCG offers Guidance on Clinical Investigations – Europe

The European Commission’s Medical Device Coordination Group (MDCG) last week issued guidance providing a set of templates that will be...