Medical Devices are subject to registration.
Manufacturers with no local presence in Malaysia must appoint a Local Authorized Representative responsible for the documentation compliance and submission to the MDA.
In case of MDA favourable outcome, an acceptance notification will be issued.
Manufacturer or the Local Authorized Representative
Timeframe and fees
About 1- 9 months.
Registration Certificate validity: 5 years
Labelling and documentation language
Medical Device Instructions for use and label can be provided in English.