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 submits a notification 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 and 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

There are two general routes Route A, primarily intended for single device imports, and Route B, for other eligible scenarios, including inventory/availability shortages; and there is a special route for import of Covid-19 related devices, which uses an abbreviated form of the Route A application. 

An illustration of these pathways is shown on the MDA website.

Navigating special access routes in response to COVID-19

Emergo by UL consultants are monitoring the development of expedited regulatory routes in medical device markets worldwide. If your device or IVD is critical to the COVID-19 response, special access or emergency use routes may be available. Contact us if you have questions about your product's eligibility or expedited regulatory pathways in countries affected by COVID-19. 

Updated on 20 April 2020.

Request Information from our Specialists

All fields are required unless specified.
* Required Field