Get your device MDA-approved — without the rejections.
One team registers your device with the MDA, keeps you compliant, and reuses the same dossier for CE and FDA — at published prices. We run device businesses ourselves, so we have sat on your side of the counter.
- MDA establishment licence
- Superbrands Malaysia 2025
- Featured on BERNAMA TV & RTM
One team, the whole climb — from first registration to FDA clearance.
Most consultancies sell one step and hand you off. We designed the practice around the full pathway, because the dossier you build at step one decides how expensive step five becomes. Every engagement starts by placing you on it.
- MY · MDA · Act 737
Register with the MDA
Classification, CSDT dossier and MeDC@St submission — your device on the Malaysian market.
- GDPMD · Establishment Licence
Get licensed to trade
GDPMD certification and the establishment licence every importer, distributor or AR must hold.
- ISO 13485
Build a manufacturer-grade QMS
The quality system that becomes the backbone of every export approval that follows.
- MDSAP
One audit, five markets
A single audit accepted in the USA, Canada, Brazil, Australia and Japan.
- CE · EU MDR · FDA 510(k)
Clear the export markets
The same dossier core carried into EU MDR technical files and US 510(k) submissions.
Pricing you can put in a budget — before you commit.
No other device-regulatory firm in Malaysia publishes its prices. Ours are below: device registration is all-in — our work, the CAB fees and the MDA statutory fees are inside — and for GDPMD, licensing and ISO 13485 we show our fee next to the certification-body and MDA fees you pay direct, so you can budget from this page alone.
Step 1 · Get licensed to operate
GDPMD + establishment licence
- GDPMD documentation, training and audit-day support, plus the licence submission via MeDC@St
- Paid direct to the CAB: GDPMD audit RM4,785 per warehouse
- Paid direct to MDA: distributor licence RM2,250 (RM250 application + RM2,000 licence); AR and importer licences carry their own MDA fees
GDPMD surveillance
- Years 2 and 3 — surveillance-audit preparation
- Paid direct to the CAB: surveillance audit RM2,585/year
ISO 13485 + MDA manufacturer licence
- QMS build, implementation and audit-day support, plus the manufacturer licence submission
- Paid direct to the certification body: certification audit RM7,500
- Paid direct to MDA: manufacturer licence RM4,250 (RM250 application + RM4,000 licence)
Step 2 · Register each device (one-off, per device, all-in — CAB + MDA fees inside)
Renewals kept on a calendar — GDPMD RM2,500/yr + CAB RM2,585 paid direct · ISO 13485 RM4,000/yr + certification body RM5,000 paid direct · re-certification and licence renewal every 3 yr · registration RM6,000 / 5 yr, all-in.
See the full pricing schedule →How much does MDA registration cost by device class?
The MDA classifies devices A–D by risk. Class A is a notification; Class B–D need conformity assessment by a registered CAB before MDA review — reflected in the all-in fee and timeline below.
| Class | Risk | Typical devices | All-in fee | Typical timeline |
|---|---|---|---|---|
| Class A | Low | Wheelchairs, simple instruments | RM3,800 | Fastest — notification |
| Class B | Low–moderate | Hospital beds, suction units | RM6,800 | ~2–3 months |
| Class C | Moderate–high | Ventilators, infusion pumps | RM9,800 | ~3 months |
| Class D | High | Implantables, life-supporting devices | RM12,000 | By scope |
Registration fees are all-in (CAB + MDA fees inside). Timelines are typical for submissions we prepare; documentation gaps on the manufacturer side are the main variable. See the full pricing schedule.
Everything a device business needs to enter, stay and expand.
Enter the Malaysian market
MDA Device Registration
Classification, CSDT documentation and MeDC@St submission under Act 737 — RM3,800 (Class A) to RM12,000 (Class D) per device, CAB and MDA fees included.
View service →Stage 02MDA Establishment License
The license every device business needs before selling — our fee RM5,500 with GDPMD; the CAB audit and the MDA licence fee are paid direct.
View service →Stage 02 · RecurringGDPMD Certification
Gap analysis to CAB certification — our fee RM5,500 in year 1, plus the CAB audit of RM4,785 per warehouse paid direct to the CAB.
View service →Stage 02 · RecurringAuthorized Representative
The legally required local representative for foreign manufacturers — registration holder, vigilance contact and license custodian on an annual retainer.
View service →Stage 01Technical File / CSDT
CSDT dossiers for MDA, EU MDR technical documentation and 510(k) content — one documentation core reused across markets.
View service →Stay compliant
ISO 13485
Manufacturer-grade quality management system implementation and certification support — the backbone of MDSAP, CE and FDA readiness.
View service →Stage 03 · RecurringPost-Market Surveillance
Complaint handling, vigilance reporting, distribution records and recall readiness run as a managed monthly retainer.
View service →Go global
MDSAP
Medical Device Single Audit Program readiness built on your ISO 13485 system — accepted in the USA, Canada, Brazil, Australia and Japan.
View service →Stage 05CE Marking (EU MDR)
Classification, technical documentation, notified body liaison and EU authorized representative coordination for the European market.
View service →Stage 05FDA 510(k)
Predicate strategy, eSTAR submission, FDA registration & listing and US agent coordination — the USA is Malaysia’s largest device export market.
View service →You’ll work with named people, not a ticket queue.
Regulatory consulting is an unregulated trade — anyone can print the title on a card. Here is who runs your file, with LinkedIn profiles you can check — and the real regulatory work behind them.
Evin Lim
Advises from the operator’s chair — the group registers, imports and supplies devices itself — and speaks on the Malaysian pharmaceutical and device industry on BERNAMA TV and RTM.
LinkedIn profileLim Yen Thong
Your first point of contact for scope, timelines and quotations. Lim Yen Thong runs the commercial side of the device practice and coordinates every engagement from first enquiry to signed proposal.
LinkedIn profile
National broadcasters vet who they put on air.
Our founder’s commentary on the Malaysian pharmaceutical and medical device industry has been broadcast by BERNAMA TV and RTM, and the group is a Superbrands Malaysia 2025 recipient. We publish every appearance so you can check ours.
Proof, not adjectives.
Everything below is checkable — a licence number, a broadcast, a public award. Named client references are available on request.
Featured on BERNAMA TV & RTM
National broadcasters vet who they put on air about the device industry. Our founder is quoted as a medical-device industry consultant.
See the coverage →Superbrands Malaysia 2025
“Malaysia’s Choice” award recipient — the group’s CEO interview ran on the official Superbrands channel in December 2025.
Watch the interview →MDA-6798-K124
We hold our own MDA establishment licence and run the same GDPMD system we build for clients — we hold what we help you get.
About the practice →Registrations expire. Certificates lapse. We keep score so you don’t.
GDPMD and ISO 13485 renew yearly, the establishment licence every 3 years, each product registration every 5 — all published, with our fee and any fee paid direct to the CAB or MDA shown separately. Add the authorized representative and post-market surveillance retainers, and nothing on your licence portfolio ever quietly expires. Prefer smooth cash flow? Register from RM1,500/month on a payment plan.
- A renewal calendar for every registration and certificate we hold for you
- GDPMD annual surveillance-audit preparation
- Complaint, vigilance and recall handling on retainer
- One consultant who already knows your file — no re-onboarding
Berapa kos pendaftaran peranti perubatan di Malaysia?
Harga kami diterbitkan. Pendaftaran peranti sudah termasuk fi CAB serta fi MDA: RM3,800 (Kelas A), RM6,800 (Kelas B), RM9,800 (Kelas C) dan RM12,000 (Kelas D) bagi setiap peranti. GDPMD dan lesen establishmen: yuran kami RM5,500; audit CAB (RM4,785 setiap gudang) dan fi lesen MDA dibayar terus oleh anda. Pelan bayaran bulanan dari RM1,500 sebulan, dan kebiasaannya lulus dalam 3 bulan. Lihat panduan penuh di halaman kos pendaftaran peranti perubatan atau WhatsApp kami di 010-206 2070.
Frequently asked questions
Do I need to register my medical device in Malaysia?
What does a medical device consultant cost in Malaysia?
Can one firm handle MDA registration and export approvals like CE or FDA?
How long does medical device registration take in Malaysia?
What happens if the MDA rejects or queries the submission?
Our device is registered in Singapore — does Malaysia accept that?
Do we need a medical device import permit in Malaysia?
Do you work with foreign manufacturers with no Malaysian office?
Work it out yourself first, if you prefer.
Everything we know about the Malaysian route is written down and public. No form, no gate — read it, and call us only if you would rather not run it in-house.
- How to register a medical device in Malaysia — the seven steps, with published fees at each stage.
- Medical device classification (Class A–D) — what decides your class, and why it changes the price.
- What registration actually costs — the three cost layers, including the renewals most people miss.
- The Singapore HSA Verification Route — for devices already on the SMDR, permanent since 1 March 2026.
- The medical device import permit — enforcement moved to 1 July 2027, not January 2026.
- ISO 13485 vs GDPMD — which quality system your company actually needs.
Tell us what you make and where you want to sell it.
We will map the approvals you need — and the order to get them in — before you commit to anything. A gap analysis gives you a realistic date and a fixed, published price.
Or call Lim Yen Thong · 010-206 2070
