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Mar 302 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...

Sep 7, 20221 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...

Feb 20, 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...

Oct 8, 20211 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...