MKS Medic
Kuala Lumpur, Malaysia
Kuala Lumpur medical device distributor and authorised representative, established in 2001.
Business types in Kuala Lumpur
Medical exhibitions in Kuala Lumpur
Regulation in Malaysia
Regulator: Medical Device Authority (MDA), Ministry of Health Malaysia
Devices must be registered with MDA before sale in Malaysia; manufacturers, authorised representatives, importers and distributors need establishment licences.
From the sourced Act 737 entry, checked 29 October 2026. General information, not legal advice. Requirements for Malaysia · All medical certifications
Frequently asked questions
Does a foreign manufacturer need a Malaysian authorized representative?
Yes. Under the Medical Device Act 2012 (Act 737), overseas manufacturers appoint a Malaysian authorized representative (AR) with a letter of authorization. The AR registers the device with the Medical Device Authority (MDA) through the MeDC@St system and holds an MDA establishment license as AR.
Importers and distributors need their own establishment licenses before they import, export or place registered devices on the market (retailers are excluded). The AR, importer and distributor can be the same company or different ones. Malaysian companies, currently more than 10, are listed on the Malaysia country page.