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There are two medical device registration holder options such as local authorized representative and distributor

Medical Device Registration Holder Options: Local Authorized Representative vs Distributor

April 3, 2026

Malaysia’s Medical Device Act 737 requires foreign medical device manufacturers...

GDPMD system setup, certification, and establishment license application in Malaysia

GDPMD System Setup, Certification, and Establishment License Application

March 31, 2026

Malaysia Medical Device Regulation 2012 mandated establishments playing the role...

Malaysia medical device regulatory affairs framework and registration requirements

Malaysia Medical Device Regulatory Affairs: Overview of Regulatory Framework and Requirements

March 11, 2026

Malaysia’s medical device market is experiencing steady growth, driven by...

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