Overview & Introduction
An introduction to Malaysia's medical device regulatory system under the Medical Device Act 2012 (Act 737) and the Medical Device Authority (MDA).
What is a Medical Device?
Statutory definition of a medical device under Malaysia's Medical Device Act 2012 (Act 737), including borderline products and exclusions.
MDA & Regulatory Framework
Overview of the Medical Device Authority (MDA), Ministry of Health Malaysia, the Medical Device Act 2012 (Act 737), and the Medical Device Regulations 2012.
Is Your Product a Medical Device?
A practical decision guide to determine whether your product falls under the scope of Malaysia's Medical Device Act 2012 (Act 737).
Key Timelines & Fees
Processing timelines and government fees for MDA establishment licences and device registration by class in Malaysia.
Regulatory Roadmap
End-to-end visual pathway for bringing a medical device to market in Malaysia, from product identification through to post-market obligations.
Legislation & Key Dates
History and key commencement dates for the Medical Device Act 2012 (Act 737), Medical Device Regulations 2012, and important MDA milestones.