Over the last few months, many foreign device companies have registered in Malaysia via the transition list. If foreign companies are not on this transition list by June 30, 2015 they will not be able to sell their devices in Malaysia for a very long time.
In addition, during the past several months, the Malaysian Medical Device Authority (MDA) has released guidance documents regarding medical device registration.
The draft guideline for device Declarations of Conformity was released in June 2015. A Declaration of Conformity is a regulatory requirement under Malaysia’s Medical Device Regulations. The document is a confirmation from the manufacturer that the device fully conforms to all safety and performance principles and other regulatory requirements. The draft guidance outlines the required content in a Declaration of Conformity, providing a template for device manufacturers to use.