Medical device manufacturers could find doing business in Malaysia more costly if new registration fees currently under consideration by the country’s Medical Device Authority (MDA) are adopted. On the table are higher registration fees for all classes of medical devices, as well as limitations on the number of device components and devices categorized as Class A or low-risk. A proposal to exempt Class B (low to moderate risk) devices from Conformity Assessment Body review is also under consideration.
The MDA will also be enforcing a regulation that requires approval from the agency of all advertisements for medical devices, whether print or broadcast. And a new post-market surveillance regulation (PMSV) is scheduled to take effect in July 2020.