The Medical Device Authority Ministry of Health in Malaysia recently released draft guidelines for “drug-medical” and “medical-drug” combination products. Previously, Malaysia lacked standards for combination product registration and regulatory requirement. Despite these draft guidelines, registering combination products in Malaysia will still take a significant amount of time.
The draft guidelines state that combination products would be regulated according to its primary mode of action. “Drug-device” combination products would have to obtain certification from a Conformity Assessment Body (CAB), then an endorsement from the Medical Devices Authority (MDA), and finally apply for registration with the National Pharmaceutical Regulatory Agency (NPRA). “Device-drug” combination products would first need NPRA endorsement, then CAB certification, and finally MDA registration. Dossiers for combination products must be submitted to the NPRA and MDA pertaining to the corresponding drug and device components.