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EMA Q&A Guidance: Updated Classification of (Post-Authorisation) Changes
Regulatory teams responsible for lifecycle management know that post-authorisation changes can quickly become complex, especially as products mature, manufacturing processes evolve, and emerging scientific data require frequent updates to quality and clinical documentation. To support consistent interpretation of EU Variation Regulation (EC) No 1234/2008, the European Medicines Agency (EMA) maintains an extensive Q&A document titled " Classification of Changes " —a practical
Sharan Murugan
Dec 7, 20254 min read
MDCG Med Dev: Guidance on Classification Rules for In-Vitro Diagnostic Medical Devices (IVDs)
The Medical Device Coordination Group (MDCG) has released the 2020-16 rev.4 guidance document, " Guidance on Classification Rules for in...
Sharan Murugan
Mar 21, 20252 min read
SAHPRA South Africa: Guideline for Classification of Medical Devices and In Vitro Diagnostics (IVDs)
The South African Health Products Regulatory Authority (SAHPRA) has released an updated " Guideline for the Classification of Medical...
Sharan Murugan
Feb 28, 20252 min read
South Africa SAPHRA: Guideline For Professional Information For Human Medicines (Categories A and D) and Classification of Medical Devices and IVDs
Recently last week the South African Health Products Regulatory Authority (SAPHRA) released an updated "Guideline For Professional...
Sharan Murugan
Mar 30, 20242 min read
Malaysia’s MDA: HARMONISED CLASSIFICATION OFMEDICAL DEVICES IN ASEAN
Association of Southeast Asian Nations, or ASEAN, is a political and economic union of 10 members states in Southeast Asia, which are...
Sharan Murugan
Sep 7, 20221 min read
Irelands HPRA Guide to Classification of a Medical Device
Throughout this guide, guidance is given on the qualification of medical devices and the application of classification rules. There is a...
Sharan Murugan
Feb 20, 20221 min read
European Commission’s MCGD New Guidance on Classification of Medical Devices
European Commission’s Medical Devices Coordinating Group (MDCG) on 04-October-2021 issued guidance to support manufacturers classify...
Sharan Murugan
Oct 8, 20211 min read