Articles & Insights

Articles with tag: malaysia

Featured

Industry News

DuoGate at Cosmobeauté Malaysia 2026 | Cosmetic Notification Malaysia

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.

September 29, 2026 By Derrick Low

Read Full Article →

Regulatory Updates

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.

September 12, 2026 6 min read

Market Access

What Happens to Your Malaysian Device Registration If You Change Authorised Representative

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.

August 21, 2026 13 min read

Compliance

Cosmetic or Medicine? Classifying Borderline Products in Malaysia

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.

August 19, 2026 14 min read

Compliance

Banned and Restricted Cosmetic Ingredients in Malaysia: What Foreign Brands Must Check

A guide to Malaysia's cosmetic ingredient annexes under NPRA and the ASEAN Cosmetic Directive, covering which annexes apply, how they are updated, transition periods for notified products, and how to screen a formula before manufacturing.

August 19, 2026 12 min read

Compliance

Cosmetic Labelling Requirements in Malaysia: A Checklist for Imported Products

A practical guide to NPRA cosmetic labelling requirements in Malaysia for imported products, covering the nine mandatory particulars, ingredient listing rules, animal origin declaration, expiry dating, small packaging exemptions, and a pre-print checklist.

August 19, 2026 11 min read

Market Access

Cosmetic Notification in Malaysia: NPRA Requirements for Foreign Brands

Learn how cosmetic notification works in Malaysia under NPRA and the ASEAN Cosmetic Directive. Understand who can be a Cosmetic Notification Holder, what the Quest 3+ process involves, labelling and PIF requirements, and why brand owners should think carefully about who holds the notification.

August 19, 2026 12 min read

← 1 2 →

Ready to bring your medical device to Malaysia?

Talk to our regulatory experts and discover how DuoGate can accelerate your journey.

Schedule a Consultation