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.
