Fees · Published · CAB + MDA fees included

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

Medical device regulatory services in Malaysia cost RM2,500–RM9,800 per device registration and RM18,000–RM25,000 for establishment licensing packages, all-inclusive, with approvals typically within 3 months. No other device-regulatory firm in Malaysia publishes its prices. Ours are below — CAB fees and MDA statutory fees included — structured as the three steps every device business actually goes through.

WhatsApp a consultant Full cost guide

Last updated: 12 July 2026

Step 1 · Get licensed to operate

Establishment license packages

Before any device can be sold, your business needs its quality system and license. One package, one price — GDPMD certification (CAB fees included) and the MeDC@St establishment license submission (MDA fees included).

FOREIGN MANUFACTURERS

Authorised Representative + Importer + Distributor

RM25,000

GDPMD certification — CAB fees included
Establishment license submission via MeDC@St — MDA fees included
All three roles licensed under one program

Start the full package

LOCAL TRADERS

Importer + Distributor

RM18,000

GDPMD certification — CAB fees included
Establishment license submission via MeDC@St — MDA fees included

Start this package

CERTIFICATE ONLY

GDPMD certification

RM10,000

Gap analysis, documentation, training
CAB certification audit — CAB fees included

Get GDPMD certified

Step 2 · Register your devices

Product registration (one-off, per device)

Class	Typical devices	All-inclusive fee	Included
Class A	Low-risk — e.g. wheelchairs, simple instruments	RM2,500	Document preparation, MDA fees, MDA follow-up
Class B	Low–moderate risk — e.g. hospital beds, suction units	RM6,000	CSDT preparation, CAB fees, MDA fees, follow-up
Class C	Moderate–high risk — e.g. ventilators, infusion pumps	RM9,800	CSDT preparation, CAB fees, MDA fees, follow-up
Class D	High risk — implantables, life-supporting devices	by quotation	Bespoke dossier scope

98% approval success rate across 100+ MDA device registrations since 2016 (AA Alive internal data); registrations typically approved within 3 months. Multi-device and family-grouping strategies quoted case by case — grouping is frequently where we save clients the most.

Step 3 · Keep everything alive

Renewals — the layer nobody budgets for

Every approval in steps 1–2 runs on a cycle. This is where device businesses quietly lose market access — and where our renewal calendar earns its keep. All renewal fees below are likewise all-inclusive.

Renewal	Cycle	All-inclusive fee	Included
GDPMD / ISO 13485 certificate	Every year	RM2,500/yr	Document preparation, CAB fees
Establishment license	Every 3 years	RM9,000	Documentation, CAB fees, MDA fees, follow-up
Product registration	Every 5 years	RM6,000	Document preparation, CAB fees, MDA fees, follow-up

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

Export and manufacturer programs are quoted after scoping, because testing and audit scope dominate the cost: ISO 13485 implementation, MDSAP readiness, CE marking (EU MDR), FDA 510(k), standalone technical files and PMS retainers. Quotations are itemized 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 011-2410 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: our professional work, the CAB fees (conformity assessment / GDPMD audit) and the MDA statutory fees are inside the quoted price. No consultant in this market publishes all-in device-regulatory pricing — we do it deliberately, so you can budget from this page alone.

How does the RM1,500/month payment plan work?

Instead of paying a package upfront, you can spread your market-entry program 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. 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 license 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.

Do you offer payment by milestones on the packages?

Yes — packages can be milestone-billed (typically on engagement, submission and approval) or converted to the monthly payment plan from RM1,500/month. Renewals are billed per cycle.

Want this as a written quotation?

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

WhatsApp a consultant