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?
Are there any exemptions or exclusions?
Special Access Routes for importing medical devices into Malaysia
Importers duties and obligations
It is mandatory for importers of medical devices and IVDs to Malaysia to:
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: