Tag: Malaysian Regulations

Healthcare, Industry News, Medical Devices, Regulatory Affairs

Malaysian MoH proposed an approach for registration of combination products

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 […]

Be the First to comment. Read More