The Malaysian MoH has published a guidance regarding the regulation of combination products that include both pharmaceutical and medical device components i.e., ‘drug-device’ combination.
As per this guidance document, the combination product’s market registration pathway is as per its primary mode of action.
Hence, the products with pharmaceutical primary actions would fall under the country’s National Pharmaceutical Regulatory Agency’s (NPRA) oversight, while products whose key components are medical devices would be regulated by the Medical Devices Authority (MDA).
For most combination products, the applicants would first have to obtain certification from a qualified Conformity Assessment Body (CAB), then obtain an endorsement from the MDA, and finally apply for registration with the NPRA. The applicants must meet particular submission dossier requirements to either the NPRA or MDA pertaining to both the drug and device components.