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AA Alive Sdn Bhd · SSM 1204108-DMDA-licensed practiceSuperbrands Malaysia 2025100+ devices registered
Medical Device Consultant.MY
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MDA · Establishment licensing under Act 737

The license your business needs before any device can move.

Device registration covers the product; the establishment license covers you. We prepare the prerequisites, file through MeDC@St and keep the license — and the duties that come with it — in good standing.

GDPMD prerequisite
01 MDA Registration02 GDPMD + Licensing03 ISO 13485 QMS04 MDSAP05 CE / FDA Export
How it works

Two tracks, one program

Companies new to the Malaysian device market usually discover the licensing requirement late — often when a hospital tender asks for the license number. Under Act 737, manufacturing, importing or distributing medical devices without an establishment license is an offence, and the license itself depends on a certified quality system: GDPMD for importers, distributors and authorized representatives, an ISO 13485-based QMS for manufacturers.

We sequence the whole program: quality-system certification, license application, then device registrations — in parallel wherever the rules allow, so your market entry date is driven by the slowest mandatory step, not by consultant hand-offs.

Rule change · In force since 28 January 2026

New for 2026: no establishment licence, no tenders.

Under Circular Letter No. 1/2026, in force since 28 January 2026, every tenderer must hold a valid MDA establishment licence before participating in any new medical device tender — non-compliance is an offence under Section 15 of Act 737. Transitional exemptions cover only tenders awarded, letters of acceptance received, or tender advertisements issued before that date, and only until the existing contract or tender activity ends.

If hospital or government supply contracts are part of your pipeline, the licence is no longer something to sort out after you win — it is the ticket to bid at all. Licensing takes months, so it belongs before the next tender cycle, not after it opens. (Verified against the official MDA portal, 10 August 2026 — the full dated digest of 2026 MDA changes is on our sister site, iso13485.my.)

What we handle

  • Role strategy — manufacturer, importer, distributor, AR, or a combination
  • GDPMD / ISO 13485 prerequisite (or verification your existing certificate qualifies)
  • MeDC@St establishment license application and query handling
  • Duty-holder procedures: distribution records, vigilance, recall
  • Renewals and change notifications (new premises, new roles, new device classes)

Packages — license and quality system in one price

PackageAll-inclusive feeIncluded
Authorised Representative + Importer + DistributorRM25,000GDPMD certification (CAB fees included) + establishment license via MeDC@St (MDA fees included) — all three roles
Importer + DistributorRM18,000GDPMD certification (CAB fees included) + establishment license via MeDC@St (MDA fees included)
License renewalRM9,000 / 3 yearsDocumentation, CAB fees, MDA fees, follow-up

Payment plans from RM1,500/month. Manufacturer licensing (ISO 13485 route) is quoted after gap analysis — WhatsApp us your role and device classes for a same-day written quote.

FAQ

Frequently asked questions

Who needs an establishment license?
Every manufacturer, importer, distributor and authorized representative placing medical devices on the Malaysian market must hold an establishment license from MDA under Act 737 — on top of each device being registered. One company can hold multiple roles under one license, but each role carries its own quality-system prerequisite.
What are the prerequisites?
Importers, distributors and authorized representatives must hold GDPMD certification from a registered CAB. Manufacturers demonstrate an ISO 13485-based quality management system. The license application is filed through MDA’s MeDC@St system with the certificate and company documents attached.
Establishment license vs device registration — which comes first?
They are parallel tracks that meet at the market: the establishment license covers the business, device registration covers each product. In most engagements we run the GDPMD/QMS work, the license application and the first device registrations as one coordinated program so nothing waits on anything unnecessarily.
What obligations come with holding the license?
The license holder is a duty holder under Act 737: maintaining the quality system, distribution records, complaint and vigilance handling, mandatory problem reporting and recall execution. Our post-market surveillance retainer exists precisely because these duties are continuous, not annual.
What does the establishment license cost, all-in?
Importer + Distributor: RM18,000. Authorised Representative + Importer + Distributor: RM25,000. Both packages include GDPMD certification with CAB fees and the MeDC@St license submission with MDA fees — one price, licensed to operate. The license renews every 3 years at RM9,000 all-inclusive. Payment plans from RM1,500/month.
Do I need an establishment licence to join a hospital tender?
Yes. Since 28 January 2026, Circular Letter No. 1/2026 makes a valid MDA establishment licence compulsory for every tenderer before participating in any new medical device tender, under Section 15 of Act 737. Transitional exemptions apply only to tenders awarded, LOAs received or tender advertisements issued before that date — and only until the existing contract or tender activity ends.

Entering the Malaysian market?

Tell us your role — manufacturer, importer, distributor or foreign brand — and we will map the licenses, certificates and registrations in the right order.

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