Medical Device Product Registration (MDA)
Who can register a medical device in Malaysia?
Only companies registered locally in Malaysia with the Companies Commission (SSM) (government authority responsible for company registrations) may apply to obtain an establishment license, register a medical device and apply for an export permit. Once registered with the SSM, a company needs to create just one account on Medcast from where they apply initially for an Establishment License according to their activity: Manufacturer’s License, Importer’s License, Distributor’s License or Authorized Representative’s License. Only companies which have an Establishment License can register a medical device in Malaysia.
Kazami Group is a regulatory affairs and market access consultancy that specializes in the registration, authorized representation, importation and master distribution of medical device and in-vitro diagnostics in Southeast Asia.
Our in-house team of local, experienced regulatory affairs specialists provide unrivalled assistance to medical device manufacturers and distributors alike who benefit from accessing real, on-the-ground expertise.
In Malaysia, applications for licensing & device registration must be submitted online via MeDC@St (Medical Device Centralised Online Application System).
Medical device product registration in Malaysia is overseen by the Medical Device Authority (MDA) of the Ministry of Health Malaysia (MoHM), as stipulated under the Medical Device Act 2012, which was made effective on July 1, 2013. According to the act, medical devices require registration with the MDA before being imported and placed on the market.