DuoGate Regulatory Solutions is at Cosmobeauté Malaysia & beautyexpo 2026 at KLCC, 29 September – 1 October. Talk to us about NPRA cosmetic notification, Cosmetic Notification Holder services and medical device registration in Malaysia.
Read Full Article →Lasers, IPL, RF and HIFU devices used in aesthetic clinics are regulated as medical devices in Malaysia, not as cosmetics. A guide for foreign manufacturers on which aesthetic equipment requires MDA registration and where the boundary sits.
In vitro diagnostic devices follow separate classification rules in Malaysia. A guide to MDA IVD registration for foreign manufacturers — the four risk classes, the seven classification rules, Authorized Representative requirements and where general device logic goes wrong.
ASEAN member states have agreed in principle to a phased Single Submission Model for medical devices, with Malaysia as the coordinating entry point.
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.
If you change your Authorised Representative in Malaysia, your device registration does not automatically follow. This guide explains what the outgoing AR controls, what happens if they will not cooperate, and the contractual protections foreign manufacturers should put in place before appointing.
How NPRA decides whether a product is a cosmetic in Malaysia, using the five-step decision process in the Guideline for Cosmetic Claims. Covers permitted secondary functions, acceptable and unacceptable claims by product type, and the wording that most often pushes an imported product out of the cosmetic category.
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