Malaysia

1、 Authorities and institutions

In Malaysia, medical devices and in vitro diagnostic devices are regulated by the Medical Device Authority (MDA) under the Ministry of Health Malaysia (MoHM)

2、 Related regulations

Regulatory Framework: Medical Device Act 2012 (Act 737) (effective July 1, 2013)

The registration process, guidelines, and risk level classification strictly follow the ASEAN Medical Devices Directive (AMDD)

MD classification: Class A, B, C, D and Combination Device, reference guide: MDA/GD/0009: Rules of Classification for General Medical Devices (2nd edition)

IVD classification: Class A, B, C, and D, reference guide: MDA/GD/0001: In-Vitro Diagnostic (IVD) Medical Device Classification System (2nd edition)

3、 Time estimation

3-8 months

4、 Local representatives

Entering the Malaysian market requires a local representative (AR), whose main responsibilities include completing registration matters, communicating with authorities, and tracking adverse feedback from manufacturers after product launch.

5、 Successful Cases

More than 3+registration cases