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EC-Medical Device Coordination Group: Guidance on Classification of Medical Devices, Nomenclature (EMDN), and Supply Continuity Obligations
The European Union continues to strengthen its medical device regulatory framework through updated guidance on device classification, nomenclature (EMDN), and supply chain transparency. These updates aim to improve regulatory clarity, traceability, and patient safety, particularly under the MDR and IVDR frameworks. Key developments include the Update – MDCG 2021-24 Rev.1: Guidance on classification of medical devices (April 2026), alongside supporting guidance documents on EM
Sharan Murugan
Apr 253 min read
Swissmedic Guidance: Clinical Trials with Medicinal Products, Submission Process and FAQs
Clinical trials are the cornerstone of developing safe and effective medicines. In Switzerland, the regulatory authority...
Sharan Murugan
Aug 28, 20252 min read
Swiss Medic: Biosimilar Authorisation Guidance
Swissmedic, the Swiss Agency for Therapeutic Products, published an updated guidance on (26 November 2023) the "Guidance document...
Sharan Murugan
Nov 26, 20232 min read
Australia TGA: FAQ Importing & Supplying Medical Devices
Recently on 3rd January, 2023 Australia's Therapeutic Goods Administration (TGA) released a guidance on frequently asked questions...
Sharan Murugan
Jan 8, 20231 min read