Skip to main content
AA Alive Sdn Bhd · SSM 1204108-DMDA-licensed practiceSuperbrands Malaysia 20251,000+ devices registered
ISO 13485.MY
Fees · Published · CAB + MDA fees included

Pricing you can put in a budget. All-inclusive, in writing.

Establishment licensing packages run RM10,000–RM25,000 and device registration RM2,500–RM9,800 per device, all-inclusive, with approvals typically within 3 months. No other quality-system consultancy in Malaysia publishes its prices. Ours are below — CAB fees and MDA statutory fees included — structured as the three gates every device business actually passes through.

ISO 13485 or GDPMD?

Last updated: 7 August 2026

Step 1 · Get licensed to operate

Certification and 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.

AUTHORISED REPRESENTATIVE, IMPORTER & DISTRIBUTOR

Authorised representative, importer & distributor

RM25,000

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

  • GDPMD certification — including CAB fees
  • Establishment licence submission — including MeDC@St and MDA fees
Start this package
IMPORTER & DISTRIBUTOR

Importer & distributor

RM18,000

You bring devices in and sell them on, but you are not the authorised representative.

  • GDPMD certification — including CAB fees
  • Establishment licence submission — including MeDC@St and MDA fees
Start this package
GDPMD CERTIFICATION ONLY

GDPMD certification only

RM10,000

You already hold the licence, or you only need the certificate.

  • GDPMD certification — including CAB fees
Start this package

Fees never include the cost of physically bringing premises and processes into compliance — the gap analysis tells you that gap in writing before you commit.

Step 2 · Register your devices

Product registration (one-off, per 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.

ClassRiskAll-inclusive feeIncluded
Class ALowest risk. Most non-sterile, non-measuring instruments.RM2,500Document preparation, MDA fees, Follow-up on MDA enquiries
Class BLow to moderate risk.RM6,000CSDT dossier preparation, CAB fees and MDA fees, Follow-up on MDA enquiries
Class CModerate to high risk.RM9,800CSDT dossier preparation, CAB fees and MDA fees, Follow-up on MDA enquiries
Class DHighest risk. Priced per device once we see the dossier.by quotationClassification review — we tell you which class your device falls in, CSDT dossier preparation, Follow-up on MDA enquiries

98% approval success rate across 1,000+ MDA device registrations since 2016; registrations typically approved within 3 months. CE-certified devices qualify for the abridged evaluation route — tell us early, it changes the dossier.

Ongoing · Keep everything alive

Renewals — the layer nobody budgets for

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.

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 plan

Register your medical device in Malaysia from RM1,500/month

Market entry should not require a lump sum. Steps 1 and 2 can be spread over monthly instalments from RM1,500/month — same scope, same timeline, cash-flow-friendly. Ask for the payment plan option in your quotation.

Quoted separately

ISO 13485 implementation is quoted after a gap analysis, because audit scope dominates the cost. Export programmes — MDSAP, CE marking (EU MDR) and FDA 510(k) — are handled by our device regulatory flagship, medicaldeviceconsultant.my. Quotations are itemised and typically issued within one working day.

Jawapan ringkas · Bahasa Malaysia

Berapa kos untuk daftar peranti perubatan di Malaysia?

Harga kami diterbitkan dan sudah termasuk fi CAB serta fi MDA: pakej lesen establishmen RM18,000 (Pengimport + Pengedar) atau RM25,000 (dengan Wakil Sah; GDPMD sahaja RM10,000) — Langkah 1; pendaftaran produk RM2,500 (Kelas A), RM6,000 (Kelas B) atau RM9,800 (Kelas C) setiap peranti — Langkah 2; dan pembaharuan dari RM2,500 setahun — Langkah 3. Pelan bayaran bulanan dari RM1,500 sebulan. WhatsApp 010-206 2070 untuk sebut harga bertulis.

FAQ

Frequently asked questions

Are CAB and MDA fees really included?
Yes. Every figure on this page is all-inclusive where stated: our professional work, the CAB fees (conformity assessment / GDPMD audit) and the MDA statutory fees are inside the quoted price. What is never included is the cost of physically bringing your premises and processes into compliance — no honest consultant can quote that sight unseen, which is why every engagement starts with a gap analysis.
How does the RM1,500/month payment plan work?
Instead of paying a package upfront, you can spread your market-entry programme over monthly instalments from RM1,500/month. It covers the same scope and the same timeline — it is a payment plan, not a reduced service. Details and eligibility are confirmed in the written quotation.
How fast will my device be approved?
Registrations we manage are typically approved within 3 months, and our submissions run at a 98% success rate across more than 1,000 devices. The variables that stretch timelines are documentation gaps on the manufacturer side — which the gap analysis surfaces before we commit to a date.
What are the renewal obligations after approval?
Three cycles: GDPMD/ISO 13485 certificates renew annually (RM2,500/year), the establishment licence renews every 3 years (RM9,000), and each product registration renews every 5 years (RM6,000). We hold the renewal calendar for every client so nothing quietly lapses.
What does ISO 13485 implementation itself cost?
ISO 13485 implementation is quoted after scoping, because audit scope and the size of your operation dominate the cost — a warehouse-only distributor and a full manufacturer are different projects. The gap analysis that opens every engagement gives you the fixed written price before you commit.

Want this as a written quotation?

Tell us your role, device classes and target markets — you will get an itemised, all-inclusive quotation, usually within one working day.