MDA establishment licence: the licence your business needs before any device can move.
Device registration covers the product; the establishment licence covers you. We prepare the prerequisites, file through MeDC@St and keep the license — and the duties that come with it — in good standing.
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 2026New 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.)
Budget 2027 puts more than RM770 million into MOH equipment next year, including haemodialysis upgrades and 400 ambulances. What that means for suppliers is on our Budget 2027 for device companies page.
Import permit · Enforcement 1 July 2027The import permit deadline moved — the licence behind it did not.
MDA postponed medical device import permit enforcement from 2 January 2026 to 1 July 2027 (announcement dated 1 December 2025); until then, existing customs import procedures continue. A voluntary ePermit phase opens on 1 June 2026 for non-medical goods sitting under medical device tariff codes.
Read that as breathing room, not a reprieve. The permit is a shipment-level control under the Customs (Prohibition of Import) Order 2023, and it assumes a licensed importer behind it. Establishment licensing takes months; the permit takes three working days. The long pole is this page's subject, not the permit. Full timeline, fees and lead times on our import permit guide.
How to check whether a company already holds a licence
MDA publishes every licensed establishment. Search by company name or licence number on MDA's public licensed-establishment search before you appoint an importer, distributor or authorised representative, and check that the licence covers the role they will play for you. For the step-by-step application itself (documents, MeDC@St screens and the order of the GDPMD audit), see the MDA establishment licence application guide on our sister site, gdpmd.my.
Choose the roles before choosing a package
A company importing and distributing devices needs the relevant importer and distributor licences. A company also acting as a foreign manufacturer’s AR needs that role covered separately. Our RM5,500 fee covers the GDPMD work and the role applications in one engagement; each role's MDA licence fee is paid direct to MDA.
Since 1 July 2024, each role requires its own licence. Existing multi-role licences are separated at renewal. Check the MDA single-role licence policy before relying on an old combined certificate.
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)
Fees — our fee, and the fees you pay direct
| Service | Our fee | Paid direct (not included) |
|---|---|---|
| GDPMD certification + establishment licence submission (year 1) | RM5,500 | CAB GDPMD audit RM4,785 per warehouse; MDA licence fee per role — distributor RM2,250 (RM250 application + RM2,000 licence), authorised representative and importer at their own MDA fees |
| GDPMD surveillance (years 2 and 3) | RM2,500/yr | CAB surveillance audit RM2,585/yr |
| GDPMD re-certification + licence renewal (every 3 years) | RM5,500 | CAB audit RM4,785 per warehouse; MDA licence renewal fee (distributor RM1,200: RM200 application + RM1,000 renewal) |
| Manufacturer licence — ISO 13485 route (year 1) | RM7,500 | Certification body audit RM7,500; MDA manufacturer licence RM4,250 (RM250 application + RM4,000 licence) |
Payment plans from RM1,500/month. WhatsApp us your role and device classes for a same-day written quote.
Frequently asked questions
Who needs an establishment license?
What are the prerequisites?
Establishment license vs device registration — which comes first?
What obligations come with holding the license?
What does the establishment license cost?
Do I need an establishment licence to join a hospital tender?
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.