Topic:授權代表

Authorised Representative (AR) for Medical Devices: a must for foreign manufacturers (Malaysia)

An overseas medical device manufacturer cannot register directly with MDA; it must first appoint a licensed Local Authorised Representative (AR) in Malaysia. The AR holds the device registration, liaises with MDA on the manufacturer's behalf, and takes on the post-market obligations. This article explains the AR's role, obligations, and key selection points.