A medical device quality system that passes its audit — and a licence that never lapses.
We build and document your ISO 13485 / GDPMD quality management system, sit the CAB assessment with you, and carry you through MDA establishment licensing and product registration — at published prices, with every certification-body and MDA fee stated separately. 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
Everything happens in one legal order. We take you through all of it.
In Malaysia a company cannot register a single device until it already holds a certified quality system and an MDA establishment licence. That ordering is the single most common thing newcomers get wrong — and the reason every engagement starts by placing you on the chain.
- Step 1 · Conformity Assessment Body (CAB), then MDA via MeDC@St
Quality system + establishment licence
Before you may register a single device in Malaysia, your company needs a certified quality management system (GDPMD, or ISO 13485 where it applies) and an establishment licence from the Medical Device Authority.
- Step 2 · MDA, with CAB verification for Class B and above
Product registration, device by device
Each device is registered separately, and the price depends on its risk class — A, B, C or D — so classification is the first thing to settle, not the last.
- Ongoing · CAB and MDA
Three renewal clocks, forever
Three separate clocks run once you are approved: the quality system is audited every year, the establishment licence is renewed every three years, and each product registration every five years.
ISO 13485 implementation & certification support
A manufacturer-grade quality management system written around how your people actually work — procedures, records, traceability, internal audit — then the certification assessment with us in the room.
ISO 13485 or GDPMD — which one? →GDPMD certification
Good Distribution Practice for Medical Devices — the certificate every importer, distributor and authorised representative needs before the MDA will issue an establishment licence. Gap analysis to CAB audit; the certification body's audit fee is paid by you directly to the certification body.
See the licensing packages →MDA product registration
Classification, CSDT dossier and MeDC@St submission for Class A–D devices — CE certificates open the abridged route, so tell us early. MDA follow-up is part of the fee, not an extra.
Per-device fees by class →A quality system an auditor can watch working.
We visit before we quote
A site visit and a written list of where you currently fall short. You see the gap before you commit to a certification body.
We write the system, not a template
Procedures, records and traceability built around how your warehouse and your people actually work, because an auditor will watch them work.
We sit the audit with you
Internal audit first, then the CAB assessment with us in the room. Non-conformities get closed out, not argued about.
We answer MDA, you keep selling
Submissions go through MeDC@St under our licence discipline, and every MDA enquiry comes to us. Follow-up is included in the fee.
The full fee table, published. Budget from this page alone.
Our fees are below, exactly as they appear in the written quotation. Product registration is all-in — CAB and MDA fees included. For certification and licensing, the certification body's audit and MDA's licence fee are paid by you directly to them; we list each one beside our fee, never inside it. Last updated: 18 September 2026.
Step 1 · Certification and establishment licence
ISO 13485 + MDA manufacturer licence
Not included in our fee — you pay these direct:
+ RM7,500 ISO 13485 certification audit — paid direct to the certification body
+ RM4,250 MDA manufacturer licence (RM250 application + RM4,000 licence) — paid direct to MDA
- QMS documentation preparation (complete set)
- Product technical file review, post-market surveillance and CAPA development
- Internal audit, management review and in-house training, and we assist and lead on audit day
- MDA manufacturer licence: documents preparation, submission and MDA follow-up through to approval
- Excludes: cost of physically complying with ISO 13485 requirements
GDPMD + MDA establishment licence
Not included in our fee — you pay these direct:
+ RM4,785 GDPMD certification audit, per warehouse — paid direct to the certification body
+ RM2,250 MDA distributor licence (RM250 application + RM2,000 licence) — paid direct to MDA
Each other licence role carries its own MDA fee, also paid direct: importer RM2,250 (RM250 application + RM2,000 licence), authorised representative RM4,250 (RM250 application + RM4,000 licence).
- Site review of warehouse requirements, feedback and adjustment
- Complete GDPMD documentation preparation
- Internal review, management review and training for your dedicated person
- We assist and lead on audit day
- Establishment licence application through MeDC@St, with follow-up on MDA enquiries
- Excludes: cost of physically complying with GDPMD requirements
GDPMD certification only
Not included in our fee — you pay these direct:
+ RM4,785 GDPMD certification audit, per warehouse — paid direct to the certification body
- Site review of warehouse requirements, feedback and adjustment
- Complete GDPMD documentation preparation
- Internal review, management review and training for your dedicated person
- We assist and lead on audit day
- Excludes: cost of physically complying with GDPMD requirements
Step 2 · Product registration (one-off, per product, all-in)
All-in per product: CAB and MDA fees included, nothing to pay anyone else. Packages, also all-in: 5 × Class A RM12,000 · 3 × Class B RM18,000 · 3 × Class C RM25,000 · 3 × Class D RM30,000.
Ongoing · Renewal — three clocks, forever
| Renewal | Cycle | Our fee | Paid direct by you | Included |
|---|---|---|---|---|
| GDPMD surveillance audit | per year, years 2 and 3 | RM2,500 | RM2,585 GDPMD surveillance audit, per warehouse — paid direct to the certification body | Site review, feedback and adjustment · Documents preparation review |
| ISO 13485 surveillance audit | per year, years 2 and 3 | RM4,000 | RM5,000 ISO 13485 surveillance audit — paid direct to the certification body | Internal audit · Documents preparation review |
| GDPMD re-certification + establishment licence renewal | year 4, then every 3 years | RM5,500 | RM4,785 GDPMD re-certification audit, per warehouse — paid direct to the certification body · RM2,250 MDA distributor licence renewal (RM250 application + RM2,000 licence) — paid direct to MDA · Other licence roles renew at their own MDA fee, also paid direct | Full certification cycle repeats: site review, documentation and internal audit · Establishment licence renewal through MeDC@St, with follow-up on MDA enquiries |
| ISO 13485 renewal + manufacturer licence renewal | year 4, then every 3 years | RM5,000 | RM7,500 ISO 13485 re-certification audit — paid direct to the certification body · RM2,200 MDA manufacturer licence renewal (RM200 application + RM2,000 licence) — paid direct to MDA | PMS and CAPA development, internal audit, training, system review and update |
| Product registration renewal | every 5 years, per product | RM6,000 | Nothing — CAB + MDA fees included | Document preparation, including product return records · CAB fees and MDA fees · Follow-up on MDA enquiries |
Standard terms: our fee is payable 50% to start, 50% on approval or completion; monthly payment plans from RM1,500/month are also available — same scope, same timeline. Certification-body and MDA fees are paid by you directly to them, when they fall due.
See the full pricing schedule →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 quality 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 — the clocks do not line up, which is why lapses happen. We hold the calendar for you and start each renewal far enough ahead that an MDA enquiry never turns into an expiry.
- A renewal calendar for every registration and certificate we hold for you
- Annual surveillance-audit preparation, records ready before the CAB asks
- MDA enquiries answered by us, under the fee — you keep selling
- One consultant who already knows your file — no re-onboarding
Berapa kos pendaftaran peranti perubatan di Malaysia?
Pendaftaran produk: RM3,800 (Kelas A), RM6,800 (Kelas B), RM9,800 (Kelas C) atau RM12,000 (Kelas D) setiap produk, termasuk fi CAB dan fi MDA. Sebelum itu, yuran kami untuk GDPMD dan lesen establishmen ialah RM5,500 bagi tahun pertama; fi audit badan pensijilan (RM4,785 setiap gudang) dan fi lesen MDA (RM2,250 untuk pengedar) anda bayar terus kepada mereka. Terma standard: 50% pada permulaan, 50% selepas kelulusan; pelan bayaran bulanan dari RM1,500 sebulan juga tersedia. Kadar kejayaan 98%, kebiasaannya lulus dalam 3 bulan. Lihat jadual harga penuh atau WhatsApp kami di 010-206 2070.
Frequently asked questions
Do I need ISO 13485 or GDPMD to sell medical devices in Malaysia?
What is the difference between ISO 13485 and GDPMD?
How long does medical device registration take in Malaysia?
How much does it cost to register a medical device in Malaysia?
What are the medical device risk classes in Malaysia?
Do I need an establishment licence if I only import medical devices?
What is an authorised representative for medical devices in Malaysia?
What is CSDT?
Does CE marking mean my device is approved in Malaysia?
How often do I have to renew?
Tell us what you import, distribute or make.
We will map the certificates and licences you actually need — and the order to get them in — before you commit to anything. A gap analysis gives you a realistic date and a written quotation, with our fee and every pay-direct fee on separate lines.
Or call 010-206 2070
