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AA Alive Sdn Bhd · SSM 1204108-DMDA-licensed practiceSuperbrands Malaysia 20251,000+ devices registered
ISO 13485.MY
ISO 13485:2016 · GDPMD · MDA establishment licence · MeDC@St · Class A–D
ISO 13485 & GDPMD consultants · Malaysia

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, all-inclusive prices. We run device businesses ourselves, so we have sat on your side of the counter.

98%approval rate · within 3 months
1,000+devices registered with the MDA
Since 2016MDA-licensed practice
See transparent pricing
  • MDA establishment licence
  • Superbrands Malaysia 2025
  • Featured on BERNAMA TV & RTM
Evin Lim on the BERNAMA TV panel Ruang Bicara: Aspirasi Ekonomi
Founder Evin Lim on BERNAMA TV · Ruang Bicara
As featured onBERNAMA TVRTMSuperbrands Malaysia 2025MDA-licensed practice
Services · The three gates

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.

  1. 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.

  2. 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.

  3. Ongoing · CAB and MDA

    Three renewal clocks, forever

    Three separate clocks run once you are approved: the quality system is renewed annually, the establishment licence every three years, and each product registration every five years.

Consultants reviewing medical-device submission documents at a meeting table
Every engagement starts by placing you on the chain.
ISO 13485:2016 · QMS

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 · RM10,000 all-in

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, CAB fees included.

See the licensing packages →
MDA · from RM2,500 per device

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 →
How we work

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.

Pricing · Published · CAB + MDA fees inside

The full fee table, published. Budget from this page alone.

No other quality-system consultancy in Malaysia publishes its prices. Ours are below, all-inclusive — our work, the CAB fees and the MDA statutory fees — exactly as they appear in the written quotation. Last updated: 7 August 2026.

No surprise fees — CAB + MDA fees included, quoted in writing · 98% approval rate · typically approved within 3 months · payment plans from RM1,500/month

Step 1 · Certification and establishment licence

Most completeYou hold devices for a foreign manufacturer and also import and distribute them.

Authorised representative, importer & distributor

RM25,000 one-off
  • GDPMD certification — including CAB fees
  • Establishment licence submission — including MeDC@St and MDA fees
  • Excludes: cost of physically complying with gdpmd requirements
You bring devices in and sell them on, but you are not the authorised representative.

Importer & distributor

RM18,000 one-off
  • GDPMD certification — including CAB fees
  • Establishment licence submission — including MeDC@St and MDA fees
  • Excludes: cost of physically complying with gdpmd requirements
You already hold the licence, or you only need the certificate.

GDPMD certification only

RM10,000 one-off
  • GDPMD certification — including CAB fees
  • Excludes: cost of physically complying with gdpmd requirements

Step 2 · Product registration (one-off, per device)

Class A
RM2,500
Lowest risk. Most non-sterile, non-measuring instruments.
Class B
RM6,000
Low to moderate risk.
Class C
RM9,800
Moderate to high risk.
Class D
By quote
Highest risk. Priced per device once we see the dossier.

Ongoing · Renewal — three clocks, forever

RenewalCycleAll-inclusive feeIncluded
GDPMD / ISO 13485 renewalannuallyRM2,500Document preparation · CAB fees
Establishment licence renewalevery 3 yearsRM9,000Documentation preparation · CAB fees and MDA fees · Follow-up on MDA enquiries
Product registration renewalevery 5 years, per deviceRM6,000Document preparation, including product return records · CAB fees and MDA fees · Follow-up on MDA enquiries

Payment plans from RM1,500/month — same scope, same timeline, cash-flow-friendly.

See the full pricing schedule →
Who you’ll work with

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.

AA Alive’s medical-device regulatory team
AA Alive’s device regulatory team, on client visits across Malaysia.
Founder & Managing Director · Regulatory authority

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 profile
Commercial Lead · Your first contact

Lim 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
The team at a GDPMD certification milestone
A GDPMD certification milestone.
The regulatory team in a client planning meeting around a boardroom table
Planning a client’s approvals.
AA Alive’s medical-device regulatory team meeting a client at the client’s premises
On a client site visit.
Recognition · As featured on

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.

Evin Lim on the BERNAMA TV panel Ruang Bicara: Aspirasi Ekonomi
BERNAMA TV · Ruang Bicara: Aspirasi Ekonomi →
Evin Lim in the Superbrands Malaysia 2025 CEO interview, with the award trophy and certificate
Superbrands Malaysia 2025 · CEO interview →
Evin Lim interviewed on RTM about medical device regulation and costs
RTM · Regulation & medical costs →
All media coverage →
Trust you can verify

Proof, not adjectives.

Everything below is checkable — a licence number, a broadcast, a public award. Named client references are available on request.

National media

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 →
Recognition

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 →
Verifiable licence

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 →
Compliance is not a one-off

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
Jawapan ringkas · Bahasa Malaysia

Berapa kos pendaftaran peranti perubatan di Malaysia?

Harga kami diterbitkan dan sudah termasuk fi CAB serta fi MDA: pakej lesen establishmen dari RM18,000 (GDPMD sahaja RM10,000); pendaftaran produk RM2,500 (Kelas A), RM6,000 (Kelas B) atau RM9,800 (Kelas C) setiap peranti. Pelan bayaran bulanan dari RM1,500 sebulan, kadar kejayaan 98%, kebiasaannya lulus dalam 3 bulan. Lihat jadual harga penuh atau WhatsApp kami di 010-206 2070.

FAQ

Frequently asked questions

Do I need ISO 13485 or GDPMD to sell medical devices in Malaysia?
To distribute medical devices in Malaysia you need a certified quality management system and an establishment licence from the Medical Device Authority (MDA). GDPMD — Good Distribution Practice for Medical Devices — is the scheme MDA requires of establishments, while ISO 13485 is the international quality management standard for medical devices and is what manufacturers and many multinational partners work to. Which one you need depends on whether you manufacture, import, distribute, or act as an authorised representative, and we settle that in the first meeting.
What is the difference between ISO 13485 and GDPMD?
ISO 13485 is an international quality management system standard for medical devices; GDPMD is the Malaysian good distribution practice requirement that establishments must meet to hold an MDA establishment licence. They overlap heavily in documentation and audit discipline, so the work of building one substantially serves the other, but they are certified separately and holding ISO 13485 does not by itself satisfy the Malaysian establishment licence requirement.
How long does medical device registration take in Malaysia?
AA Alive completes the process within three months for most clients, with a 98% success rate across more than 1,000 devices. The timeline depends on the risk class of the device and how quickly your manufacturer supplies the technical documentation — a Class A device with a complete dossier moves fastest, and Class C or D submissions take longer because the evaluation is deeper.
How much does it cost to register a medical device in Malaysia?
Establishment licensing starts at RM10,000 for GDPMD certification alone and runs to RM25,000 for a full authorised representative, importer and distributor package; product registration is RM2,500 for Class A, RM6,000 for Class B, and RM9,800 for Class C, with Class D quoted per device. These fees include CAB and MDA charges where stated, but never the cost of physically bringing your premises and processes into compliance. Payment can be spread from RM1,500 a month.
What are the medical device risk classes in Malaysia?
Malaysia classifies medical devices into four risk classes — A, B, C and D — with Class A the lowest risk and Class D the highest. Classification drives the registration route, the depth of the dossier, and the fee, so getting it right at the start avoids a rejected submission. If you are unsure which class your device falls into, send us the specification and we will classify it.
Do I need an establishment licence if I only import medical devices?
Yes — importers require an establishment licence from the Medical Device Authority, the same as distributors and authorised representatives. Our importer and distributor package is RM18,000 and covers GDPMD certification including CAB fees, plus the establishment licence submission including MeDC@St and MDA fees.
What is an authorised representative for medical devices in Malaysia?
An authorised representative is the Malaysian entity a foreign manufacturer appoints to hold the device registration and answer to the Medical Device Authority on its behalf. A manufacturer based outside Malaysia cannot register a device directly, so appointing an authorised representative is the route to market. Our RM25,000 package covers the authorised representative, importer and distributor role together.
What is CSDT?
CSDT is the Common Submission Dossier Template, the structured technical file format the Medical Device Authority requires for Class B, C and D device registrations. It gathers the device description, design verification, risk analysis, clinical evidence and labelling into one prescribed layout. Class A registrations do not need a full CSDT, which is why they cost less and move faster.
Does CE marking mean my device is approved in Malaysia?
No — a CE-marked device still has to be registered with the Medical Device Authority before it can be sold in Malaysia, but CE certification opens the abridged evaluation route, which is considerably simpler than a full assessment. Tell us early if your device carries CE, because it changes both the dossier we prepare and how long the review takes.
How often do I have to renew?
Three clocks run in parallel: the GDPMD or ISO 13485 quality system is renewed annually at RM2,500, the establishment licence every three years at RM9,000, and each product registration every five years at RM6,000. They do not fall due together, which is the usual reason a licence lapses. Complete records and traceability must be in place for each assessment.

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 fixed, published price.

See pricing

Or call 010-206 2070

AA Alive’s own medical-device warehouse in Batu Caves, stacked with boxed devices