Process guide · Act 737 · Updated for 2026
How to register a medical device in Malaysia, step by step.
Seven steps from an unregistered product to an MDA certificate — what each one requires, who has to do it, what it costs, and which of them changed in 2026. Written to be followed, whether or not you hire anyone to do it.
01 MDA Registration02 GDPMD + Licensing03 ISO 13485 QMS04 MDSAP05 CE / FDA Export
Before step one
Three approvals, three levels — they are not interchangeable.
Most first-time confusion comes from treating Malaysian device approval as one thing. It is three, at different levels, and you generally need all of them:
- Business level — an establishment licence giving your company the right to manufacture, import, distribute or act as an authorized representative at all.
- Product level — registration of the specific device with MDA under the Medical Device Act 2012 (Act 737).
- Shipment level — an import permit, which is coming but not yet enforced (1 July 2027).
The seven steps
- Classify the device. Class A, B, C or D, decided by intended purpose, invasiveness and duration of contact under the ASEAN rules in MDA/GD/0062. Lodge a classification application in MeDC@St — fully online since 1 August 2026, letters by email only. This drives everything downstream, so it is genuinely step one. See the full classification guide.
- Appoint an authorized representative — foreign manufacturers only. A manufacturer without a Malaysian entity cannot hold a registration. Act 737 requires a locally incorporated authorized representative who holds the registration, holds the establishment licence, and answers to MDA for vigilance and recalls. Malaysian companies registering their own products skip this step.
- Get the business licensed. The establishment licence requires a quality system: GDPMD for importers, distributors and ARs; an ISO 13485-based system for manufacturers. This is the longest step for an unlicensed company — start it in parallel with step 4, not after it.
- Build the CSDT dossier. The Common Submission Dossier Template covers device description, essential principles conformity, labelling and IFU, risk management and clinical evidence. If you hold CE or FDA documentation, most of this is a restructuring job rather than new work.
- Pass conformity assessment — Class B, C and D. A registered Conformity Assessment Body reviews the dossier before MDA will consider the application. Class A skips this entirely. If your device is already on the Singapore Medical Device Register, the Verification Route applies here and here only.
- Submit through MeDC@St. The application is lodged with MDA, statutory fees are paid, and queries come back through the system. Answering queries well is most of the work at this stage — an unanswered or poorly answered query is the common route to a rejection.
- Hold the certificate and run the calendar. Registration is not a one-off. GDPMD or ISO 13485 renews annually, the establishment licence every 3 years, the device registration every 5. MDA's automated re-registration route, announced 10 July 2026, reduces the resubmission burden at the 5-year mark for compliant registrations.
Published fees, by stage.
| Stage | Applies to | All-inclusive fee |
|---|---|---|
| GDPMD certification only | Importers, distributors, ARs | RM10,000 |
| Establishment licence — Importer + Distributor | Malaysian trading companies | RM18,000 |
| Establishment licence — with Authorised Representative | Foreign manufacturers | RM25,000 |
| Device registration — Class A / B / C | Per device | RM2,500 / 6,000 / 9,800 |
| Renewals — GDPMD / licence / registration | Recurring | RM2,500/yr · RM9,000/3yr · RM6,000/5yr |
CAB fees and MDA statutory fees are inside every figure. Payment plans from RM1,500/month. The three cost layers are broken down in the cost guide.
What changed in 2026
Three things worth folding into any plan written before this year. The Singapore Verification Route became permanent on 1 March 2026, shortening step 5 for devices already on the SMDR. The import permit did not start on 2 January 2026 as widely reported — MDA postponed enforcement to 1 July 2027. And Circular Letter No. 1/2026, in force since 28 January 2026, makes a valid establishment licence compulsory before participating in any new medical device tender, which moves step 3 much earlier for anyone selling into government or hospital contracts.
Where this usually goes wrong
- Starting with the dossier instead of the classification. Build a Class A dossier for a Class B device and the work is not merely incomplete, it is on the wrong route.
- Leaving licensing until the device is approved. The registration has to be held by a licensed entity. An approval landing against an unlicensed company is a stalled launch.
- Registering devices one at a time. Grouping rules — single, family, system, set — are decided at classification and are usually where a multi-product budget is actually reduced.
- Letting the renewal calendar lapse. A lapsed GDPMD takes the establishment licence with it, and the licence takes the registrations.
Jawapan ringkas · Bahasa Malaysia
Bagaimana cara mendaftar peranti perubatan di Malaysia?
Tujuh langkah: (1) tentukan kelas peranti (A–D) melalui MeDC@St, (2) lantik Wakil Sah tempatan jika pengeluar adalah syarikat asing, (3) dapatkan lesen establishmen bersama GDPMD atau ISO 13485, (4) sediakan dosir CSDT, (5) lalui penilaian pematuhan CAB bagi Kelas B–D, (6) hantar permohonan melalui MeDC@St, (7) uruskan kalendar pembaharuan. Kos: RM2,500 (Kelas A), RM6,000 (Kelas B), RM9,800 (Kelas C) setiap peranti — termasuk fi CAB dan MDA. WhatsApp 010-206 2070 untuk pelan lengkap.
FAQ
Frequently asked questions
What is the actual order of the steps?
Classify the device, appoint an authorized representative if the manufacturer is foreign, get the business licensed (establishment licence plus GDPMD), build the CSDT dossier, pass CAB conformity assessment for Class B–D, submit through MeDC@St, then run the renewal calendar. The business-side licensing and the device-side dossier can proceed in parallel — that is the main way to compress the overall timeline.
Can I do this myself without a consultant?
Legally, yes. A Malaysian company with a regulatory affairs professional on staff can run the whole process directly with MDA. The realistic trade-off is cycle time rather than fees: a queried or rejected submission costs months of market delay, which usually dwarfs the consultant cost. Most companies hybridize — their team owns the product knowledge, an external team owns the regulatory mechanics.
How long does the whole thing take?
Registrations we manage are typically approved within 3 months once submitted, but that clock starts after the dossier is built and, for Class B–D, after CAB conformity assessment. If the business is not yet licensed, the establishment licence and GDPMD are the long pole — months, not weeks — so a realistic end-to-end plan for an unlicensed company is longer than the registration figure alone suggests.
What is MeDC@St?
MDA’s online system for medical device submissions — classification applications, establishment licence applications and device registrations all run through it. Since 1 August 2026 classification is fully online with letters issued by email only. MDA has also announced an automated re-registration route (10 July 2026) that reduces resubmission work at the 5-year renewal.
Do I need an import permit before I can ship?
Not yet. MDA postponed medical device import permit enforcement from 2 January 2026 to 1 July 2027; until then, importation follows the existing customs procedures. When it does start, the permit is a per-shipment control at RM130 per application, applied for at least 7 days before shipment — separate from, and additional to, product registration.
Is there a shortcut if the device is registered elsewhere?
Only for Singapore, and only for the conformity assessment step. Since 1 March 2026, Class B–D devices already on the Singapore Medical Device Register can use MDA’s Verification Route under guidance MDA/GD/0070, where the CAB verifies the HSA approval rather than performing a full assessment. CE marking and FDA clearance help the dossier but do not create a comparable reliance pathway.
What can we do while registration is in progress?
Not sell. Placing an unregistered medical device on the Malaysian market is an offence under Act 737. Importing for demonstration or clinical evaluation runs through separate, narrow pathways with their own conditions — worth confirming before anything ships, not after it is held.
What does the whole process cost?
Device side: RM2,500 (Class A), RM6,000 (Class B) or RM9,800 (Class C) per device, all-inclusive. Business side, if not yet licensed: RM18,000 for Importer + Distributor or RM25,000 including Authorised Representative, both with GDPMD and MDA fees inside. Then the recurring layer — GDPMD RM2,500/year, licence RM9,000 every 3 years, registration RM6,000 every 5 years.
Want this run for you instead?
We take the whole path end to end — classification through certificate — at a published, all-inclusive price. Tell us the device and your role and we will map the steps that actually apply to you.