The MAH rule
Filings run through MEDCAST via a licensed Malaysia Authorized Holder — licences valid 5 years, transferable.
Free field guide · PDF
Malaysia MDA Medical Device Registration2026 Field Guide
The MAH rule, ASEAN reliance routes, and the class-based timeline map — for Southeast Asia's fastest second market.
- Licence validity
- 5 yrs
- Class D timeline
- 220 days
- Class D MDA fee
- US$900
Sourced from MDA 2026 registration guidance and ASEAN practice.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — MDA 2026 registration guidance and ASEAN practice.
ASEAN reliance
Reference-country approvals unlock the verification procedure — permanent from 1 March 2026.
Timeline & fee map
Official timelines from 45 working days (Class A) to 220 (Class D), with the MDA fee ladder.
Sources & scope
- elendilabs.com, medical device registration in Malaysia: MDA requirements, ASEAN alignment.
- arazygroup.com, Malaysia.
- portal.mda.gov.my, guideline for registration of combination products.
- trustedtracemed.com, ASEAN market entry reference.
This guide is market-access intelligence, not regulatory or legal advice. MDA timelines, fees, and reliance routes are product-specific — professional review is required before business use.
Market Access Strategy Session
Malaysia on your roadmap? Start with the full picture.
A Market Access Strategy Session maps your MDA route — MAH selection, reliance-route sequencing, and the ASEAN dossier plan.
Professional review is required before business use.
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