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Posts in category: Regulatory Affairs

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APACMed India Position Paper on EU MDR & IVDR

August 30, 2021

by Cissy Chen

Risk-based Regulatory Oversight of Research Use Only (RUO) Products

by Cissy Chen

Regulatory Reliance For The Registration Of Medical Devices In Asia Pacific

by Cissy Chen

Understanding-EU-Medical-Device-Regulation

Understanding Europe’s Medical Device Regulation

by Cissy Chen

APACMed Position Letter on New Medical Device Regulations in Thailand

by Cissy Chen

APACMed Position Paper with Recommendations to Facilitate Adoption of the Requirements for Labelling of Medical Devices

APACMed Position Paper with Recommendations to Facilitate Adoption of the Requirements for Labelling of Medical Devices

by Cissy Chen

APACMed_EU IVDR Position Paper

APACMed EU-IVDR Position Paper

by Cissy Chen

MDR Position Paper

Establishing Regulatory Agility to Manage Changes due to EU Medical Device Regulation in Asia Pacific

by Cissy Chen

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APACMed, AHWP/GHWP & Accenture Joint Paper on ‘Medical Device Regulatory Training Curriculum for Industry Professionals’

by Cissy Chen

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Regulatory Advances in Artificial Intelligence/Machine Learning

February 11, 2021

by Cissy Chen