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
Short answer: to register a medical device in Malaysia, you classify it (Class A–D), make sure a Malaysian licensed establishment will hold the registration, build a CSDT dossier, pass CAB conformity assessment for Class B–D, and submit the application to the Medical Device Authority (MDA) through MeDC@St. Registration is required by the Medical Device Act 2012 (Act 737) before the device can be imported, sold or supplied, and it is valid for 5 years.
Before step oneThree 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 at a glance
| Step | Who does it | Applies to | What you end up with |
|---|---|---|---|
| 1. Classify the device | Manufacturer or its representative | Every device | Class A–D and the rule applied |
| 2. Appoint an authorized representative | Foreign manufacturer | Manufacturers with no Malaysian entity | A local registration holder |
| 3. Get the business licensed | Importer, distributor, AR or manufacturer | Every company placing devices on the market | Establishment licence backed by GDPMD or ISO 13485 |
| 4. Build the CSDT dossier | Registration holder, with the manufacturer | Every device | A submission-ready technical dossier |
| 5. Conformity assessment | Registered CAB | Class B, C and D | CAB conformity assessment report |
| 6. Submit through MeDC@St | Registration holder | Every device | MDA registration certificate |
| 7. Maintain and renew | Registration holder | Every device | Licence renewal every 3 years, registration every 5 |
The seven steps
- Classify the device. Class A, B, C or D, set by Rules 1–16 in the First Schedule of the Medical Device Regulations 2012 (explained in MDA/GD/0009; see all MDA guidance documents) and checked against the ASEAN harmonised list in MDA/GD/0062. The manufacturer classifies; the class and the rule applied go into the registration application. MDA’s separate online product classification application (fully online since 1 August 2026) only confirms whether a borderline product is a medical device at all — it does not assign a class. This drives everything downstream, so it is genuinely step one. See the full classification guide, with category guides for IVDs, dental devices, aesthetic devices and surgical instruments.
- 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 already holds a recognised approval (EU notified body, US FDA, Health Canada, TGA, Japan MHLW, UK MHRA, Singapore HSA or Thai FDA), the verification route applies here and here only; otherwise the CAB runs a full conformity assessment.
- 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. Plan annual GDPMD or ISO 13485 maintenance and follow the CAB recertification schedule; the establishment licence renews 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. See MDA renewals for the windows and fees, and advertisement approval before any public campaign.
Published fees, by stage.
| Stage | Applies to | Our fee | Paid direct (not included) |
|---|---|---|---|
| GDPMD certification + establishment licence submission (year 1) | Importers, distributors, ARs | RM5,500 | CAB GDPMD audit RM4,785 per warehouse; MDA licence fee per role — distributor RM2,250 (RM250 application + RM2,000 licence), AR and importer at their own MDA fees |
| Device registration — Class A / B / C / D | Per device | RM3,800 / 6,800 / 9,800 / 12,000 | None — all-in, CAB and MDA fees included |
| 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) |
| Registration renewal | Every 5 years | RM6,000 | None — all-in, CAB and MDA fees included |
Device registration figures include CAB and MDA statutory fees; for GDPMD and licensing, the CAB and MDA fees are paid direct, as listed. 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) mengikut peraturan pengelasan MDA, (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 pendaftaran: RM3,800 (Kelas A), RM6,800 (Kelas B), RM9,800 (Kelas C), RM12,000 (Kelas D) 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 establishment licence applications and device registrations. Product classification applications — which only confirm whether a borderline product is a medical device, not its risk class — run through a separate online Product Classification Application System, fully online since 1 August 2026 with letters issued by email; from 1 October 2026 a new letter is valid for 5 years. 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?
Yes, for the conformity assessment step only. If a Class B–D device already holds an approval from a regulator MDA recognises (an EU notified body, US FDA 510(k) or PMA, Health Canada, TGA, Japan MHLW, UK MHRA, Singapore HSA or Thai FDA), the CAB verifies that approval under MDA/GD/0068 and MDA/GD/0070 instead of running a full conformity assessment. The device must have the same design and intended purpose as the approved one. Registration with MDA, an establishment licence and a Malaysian authorised representative are still required.
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: RM3,800 (Class A), RM6,800 (Class B), RM9,800 (Class C) or RM12,000 (Class D) per device, all-in — CAB and MDA fees included. Business side, if not yet licensed: our fee of RM5,500 for GDPMD and the establishment licence submission, plus two fees paid direct — the CAB’s GDPMD audit (RM4,785 per warehouse) and the MDA licence fee for each role (distributor RM2,250; authorised representative and importer licences carry their own MDA fees). Then the recurring layer — GDPMD surveillance at our fee of RM2,500/year plus the CAB’s RM2,585/year paid direct, GDPMD re-certification and licence renewal every 3 years, and registration renewal at RM6,000 every 5 years.
Want this run for you instead?
We take the whole path end to end — classification through certificate — at published fees. Tell us the device and your role and we will map the steps that actually apply to you.