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MDCG Med Dev: Guidance and Templates for Conformity Assessment Bodies, Notified Bodies, Designating Authorities, and Joint Assessment Teams
The Medical Device Coordination Group (MDCG) Â has released its updated guidance and templates for conformity assessment bodies, notified...
Sharan Murugan
Oct 14, 20242 min read
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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...
Sharan Murugan
Sep 9, 20242 min read
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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...
Sharan Murugan
Mar 2, 20242 min read
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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...
Sharan Murugan
May 9, 20231 min read
113 views
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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...
Sharan Murugan
Mar 11, 20231 min read
145 views
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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...
Sharan Murugan
May 28, 20211 min read
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