Regulatory Authority

Medical Device Authority (MDA)


Classification

A, B, C, D


Quality system

ISO 13485


Procedure

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.


Applicant

Manufacturer or the Local Authorized Representative


Timeframe and fees

About 1- 9 months


Validity

Registration Certificate validity: 5 years


Labeling and documentation language

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