ASEAN Agrees on a Single Submission Model for Devices
ASEAN member states have agreed in principle to a phased Single Submission Model for medical devices, with Malaysia as the coordinating entry point.
Regulatory Updates
Articles with tag: ASEAN
Market Access
IMDEC 2026: Medical Device Registration in Malaysia
We're at IMDEC 2026 in Kuala Lumpur. Here's who we've been meeting, why Malaysia keeps coming up, and a plain-English guide to registering a device with the MDA.
Market Access
What Is an Authorized Representative for Medical Devices in Malaysia?
Learn what a Malaysia medical device authorized representative is, why foreign manufacturers need one, how the AR supports Medical Device Authority (MDA) registration in Malaysia, and how it differs from an importer or distributor.