Malaysia: Guideline for Registration of Orthopoxvirus (Monkeypox) IVD Test Kits by MDA

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 Orthopoxvirus (Monkeypox) IVD Test Kits.

Further information on the guideline available here.