Importing Medical Devices into Malaysia

A foreign manufacturer must have a local authorised representative (a locally registered business entity) to register its medical devices with the Medical Device Authority (MDA) before the devices can be imported into Malaysia. Unregistered medical devices may be imported but need special authorisation from MDA irrespective of the import purpose (e.g.exhibition, demonstration, clinical or non-clinical use).

A local distributor can import and distribute the products in Malaysia. It can also register the products on the manufacturer's behalf. However, it may be more prudent to appoint an independent consultancy such as Cubic Life Sciences to act as their authorized regulatory representative. This type of arrangement allows the manufacturer to protect their proprietary and sensetive informaiton, remove the potential conflicts of interest in the event of a product incident, allow distributor to focus on sales and marketing whilst the regulatory affairs consultant manages the regulatory aspects of the products.

Importing Requirements

Product Registered by Local Authorised Representative with The Medical Device Authority

Importer Licence