Malaysia Emergency Use Pathways for Medical Devices

Medical devices and IVDs are regulated by the Medical Device Authority in Malaysia. The standard process includes Conformity Assessment and MDA approval for Classes B – D devices, and only MDA approval for Class A devices. This process generally takes several months to complete.

In the case of emergency or pandemic situations, the MDA has special access routes that allows for the importation and sale of devices without the normal registration requirements. Under the special access route, the importer or AR submits a request to the MDA prior to import.

In response to the Covid-19 outbreak, the MDA has additionally outlined a special route for COVID-19 related devices.

Regulations, Guidance, and Resources

The special access route is based on and described further in the following legislation and guidance:

Device types/Eligibility Criteria

Covid-19 IVD Test Kits and face masks are specifically noted on the MDA special access webpage, and have a special route.

An exemption from the registration via Special Access route may be requested for the importation, distribution, and sale of personal protective equipment (PPE) that is classified as a medical device.

Frequent updates are made, and the MDA website should be checked for current information.

In general, the MDA does not specify particular devices; the special access route is available for several different scenarios, including alleviation of inventory supply. 

Devices that require installation, such as CT scanners or X-ray machines, are specifically excluded from the program.

Pathway Overview

The guidance describes two general routes: Route A, primarily intended for single device imports, and Route B, for other eligible scenarios, including inventory/availability shortages. However, the MDA announced that they no longer consider Special Access notification through Route A for COVID-19 related devices. Any person who wishes to request exemption from registration requirements through Special Access Notification for medical devices will need to go through Route B.

The Notification procedure is described in section 4 of MDA/GD/0043.

The MDA may request validation testing of some products in local labs prior to special access approval.

Updated on 17 February 2021.

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