Full Checklist of Documents for MDA Medical Device Registration Malaysia (2026)
Quick Answer MDA registration requires administrative documents (establishment licence, AR declaration, GMDN code), a completed CSDT, ERSP checklist, risk management file, clinical evidence, labelling and IFU, and ISO 13485 certification. Requirements scale by class — Class A submits directly to MDA; Class B, C, and D require a full CSDT and CAB conformity assessment first. …
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