How to Register a Medical Device in Malaysia

This video provides a clear, step-by-step guide to entering Malaysia’s fast-growing medical device market, highlighting both the opportunities and the regulatory requirements manufacturers must meet. With a population of over 34 million, strong government support for medical tourism, and a heavy reliance on imports (accounting for around 95% of the market) Malaysia offers an attractive entry point for global medtech companies. The sector is projected to reach USD $4.46 billion by 2029, growing at a 7.12% CAGR, with the in vitro diagnostics (IVD) market also expanding steadily.

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Topics covered in this video include:

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• Key drivers behind Malaysia’s growing medical device market
• The MDA’s risk-based classification system and registration process
• When CAB review is required and how it affects timelines
• The mandatory role and qualifications of a Local Authorized Representative
• How Pure Global streamlines registration and maintains compliance post-launch

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All medical devices sold in Malaysia must be registered with the Medical Device Authority (MDA) under the Medical Device Act 2012. The MDA oversees a risk-based classification system (Class A (lowest risk) through Class D (highest risk)) which determines the complexity of the registration process, the type of documentation required, and whether review by a Conformity Assessment Body (CAB) is necessary before MDA submission. This classification step is critical, as it directly impacts timelines and approval pathways.

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For foreign manufacturers, one of the most important requirements is appointing a Local Authorized Representative (AR). The AR must hold an Establishment License and Good Distribution Practice for Medical Devices (GDPMD) certification. Acting as the manufacturer’s in-country liaison, the AR manages regulatory submissions, coordinates CAB reviews when applicable, and ensures full compliance with post-market obligations such as vigilance reporting and product recalls.

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Need MDA approval?
Pure Global’s Kuala Lumpur–based regulatory team provides end-to-end support, from determining product classification and compiling technical documentation to acting as your AR and liaising with the MDA. With expertise in managing CAB reviews and a single-process strategy that can open access to multiple ASEAN markets, we reduce complexity, shorten approval timelines, and keep you compliant after market entry. Learn more about MDA Malaysia Medical Device Registration.

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