Regulatory Authority

Medical Device Authority (MDA)


A, B, C, D

Quality system

ISO 13485


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

Labeling and documentation language

Medical device Instructions for use and label can be provided in English.