Regulatory Updates

MDA has released a new guideline document for the registration of Orthopoxvirus (Monkeypox) IVD Test Kits, entitled “Guideline for Registration of Orthopoxvirus (Monkeypox) IVD Test Kits” (MDA/GL/09), First Edition” dated September 2022. The guidance document entails the registration requirements, registration process flow, classification, evaluation timeline, application and registration fees of

On September 5th 2022, the MDA released two First Edition Guidance Document: “Harmonized Classification of Medical Devices In ASEAN” (MDA/GD/0062) and the First Edition Guidance Document: “Harmonized Borderline Products in ASEAN” (MDA/GD/0063). These guidance documents are mostly concerned with: Harmonized list of risk classification of medical devices including in-vitro diagnostic