The new Medical Device Act has been in effect in Malaysia since July 1, 2013, introducing the requirement to register Medical Devices. Medical Device manufacturers in Malaysia now have to register their medical devices within two years. Foreign manufacturers, local authorised representatives (LARs), importers and distributors have one year to obtain an establishment license from the Malaysian Medical Device Authority. Together with the new law, the Malaysian Medical Device Authority has activated MEDCAST, a web-based online application system for all registrations and licenses.
The first Malaysian Medical Device Act comprises two parts. Act 737 defines the conditions under which Medical Devices will be registered for or prevented from entering the Malaysian market. Act 738 establishes the Malaysian Medical Device Authority (MDA) as the new regulatory body charged with enforcing the new regulations. The new authority's structure and responsibilities are similar to those of the regulatory bodies in the EU or the FDA in the United States.
The Malaysian Medical Device approval system is similar to that in Singapore. It is based on risk classification in one of the following four classes: A (lowest risk), B (low to moderate risk), C (moderate to high risk) and D (highest risk). Before a Medical Device is finally registered by the Medical Device Authority, the application for its registration must be reviewed and certified by a registered Conformity Assessment Body such as TÜV SÜD. Foreign manufacturers that do not have a branch office in Malaysia need a local authorised representative (LAR) to carry out the registration on their behalf and control the required post-market surveillance of the device.
Medical device manufacturers, importers and exporters, distributors and local authorised representatives can now register in the new central online application system, MEDCAST. In the future, establishment licensing of companies, registration of medical devices and applications for export permits will be completed exclusively online. The transition period for establishment licenses will end on June 30 2014. Registration of Medical Devices, including those that have already been sold in Malaysia and all new devices must be completed by June 30 2015.
