Medical device importation to Malaysia
Only registered medical devices may be imported into Malaysia, which means that the product is listed on the Malaysian Medical Device Authority Register (MDAR) unless exempted from registration (see below). Any company wishing to import medical devices and in-vitro diagnostics (IVDs) into Malaysia must have a valid Establishment Licence as an Importer from the Medical Device Authority (MDA).
What are the requirements for importing medical devices into Malaysia?
- Only local Malaysian companies can apply for an Establishment License as an importer from the Medical Device Authority (MDA) via the Medcast system
- The importer must have a valid Importer’s License and shall only import registered medical devices that have been authorized by the Local Authorized Representative (LAR).
- A Letter of Authorization for Importer must be provided by the LAR to the importer for all products and models of the devices which are to be imported. The Letter of Authorization for Importation must be issued on the LAR’s Letterhead.
- More than one importer may be authorized by the LAR to import your device giving you freedom in your market acccess
- The importer must also hold valid Good Distribution Practice for Medical Devices (GDPMD) certification with the scope that relates to your medical device.
Are there any exemptions or exclusions?
- Certain products may be imported using Special Access Routes (see below).
Special Access Routes for importing medical devices into Malaysia
- Custom-made medical devices that have been requested for a named patient by a healthcare practitioner may be imported if a lack of registered alternative is proven
- Medical devices used by healthcare practitioners in emergency settings or where conventional treatments have failed
- Products that are destined for non-clinical purposes such as clinical evaluation, demonstration or education.
Importers duties and obligations
It is mandatory for importers of medical devices and IVDs to Malaysia to:
- Maintain their GDPMD certification and a valid Importer’s Licence
- Maintain a record of all imports (and exports)
- Maintain records of any complaints
- Report any adverse effects or field corrective actions to the Medical Device Authority as well as to the local authorized representative
How Andaman Medical can help with importing medical devices to Malaysia:
Acting as your independent local authorized representative or marketing authorization holder in Malaysia, we will work with your licensed importers to:
- authorize your selected importers to import your devices into Malaysia
- ensure that your licensed importer maintains post-market surveillance of your registered product
- liaise with your licensed importer concerning the mandatory reporting of Adverse Events and Field Corrective Actions