Fees · Published · Our fee and fees paid direct, shown separately

Pricing you can put in a budget. Every fee, in writing.

Medical device registration in Malaysia costs RM3,800 (Class A) to RM12,000 (Class D) per device with CAB and MDA fees included, with approvals typically within 3 months. For GDPMD, establishment licensing and ISO 13485, our fee is shown next to the certification-body and MDA fees you pay direct. No other device-regulatory firm in Malaysia publishes its prices. Ours are below — structured as the three steps every device business actually goes through.

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Fee schedule last changed: 18 September 2026 — re-verified against current CAB and MDA charges on the review date at the foot of this page.

Step 1 · Get licensed to operate

GDPMD, establishment licence and ISO 13485

Before any device can be sold, your business needs its quality system and licence. The figure on each card is our fee. The certification body's audit and the MDA licence fee are paid by you, direct to them — they are listed under our fee and are not included in it.

IMPORTERS · DISTRIBUTORS · ARs

GDPMD + establishment licence

RM5,500 our fee, year 1

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); authorised representative and importer licences carry their own MDA fees

Start GDPMD + licence

RECURRING

GDPMD surveillance

RM2,500/year, our fee

Years 2 and 3 — surveillance-audit preparation
Paid direct to the CAB: surveillance audit RM2,585/year

Keep my certificate alive

MANUFACTURERS

ISO 13485 + MDA manufacturer licence

RM7,500 our fee, year 1

QMS build, implementation, internal audit 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)

Scope my ISO 13485

Already licensed and only need the GDPMD certificate? Same RM5,500 our fee, plus the CAB audit paid direct — no MDA licence fee.

Step 2 · Register your devices

Product registration (one-off, per device, all-in)

Class	Typical devices	All-in fee	Included
Class A	Low-risk — e.g. wheelchairs, simple instruments	RM3,800	Document preparation, MDA fees, MDA follow-up
Class B	Low–moderate risk — e.g. hospital beds, suction units	RM6,800	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	RM12,000	CSDT preparation, CAB fees, MDA fees, follow-up

Multi-product packages (all-in)

Class	Products	All-in fee
Class A	5 products	RM12,000
Class B	3 products	RM18,000
Class C	3 products	RM25,000
Class D	3 products	RM30,000

1000+ MDA device registrations since 2016; registrations typically approved within 3 months, with MDA queries and resubmissions handled in scope. The number of registrations a package covers is subject to MDA grouping rules; family-grouping strategies are quoted case by case — grouping is frequently where we save clients the most.

MDA statutory fees in 2026

These are MDA application and registration charges, before consultancy or CAB work. Our product registration fees already include the applicable MDA fees: do not add this table to them a second time.

Standard device applications · Malaysian ringgit (RM)
Class	Application	Registration	MDA total
A	500	750	1,250
B	250	1,000	1,250
C	500	2,000	2,500
D	750	3,000	3,750

Class A changed on 1 January 2026 under P.U. (A) 330/2025; the old RM100 application figure is superseded. Devices containing a medicinal product have a separate registration fee and need a scoped quotation. Sources checked 7 September 2026: MDA Class A fee amendment and MDA fee schedule for Classes B–D.

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.

Renewal	Cycle	Our fee	Paid direct (not included)
GDPMD surveillance	Years 2 and 3	RM2,500/yr	CAB surveillance audit RM2,585/yr
ISO 13485 surveillance	Years 2 and 3	RM4,000/yr	Certification body audit RM5,000/yr
GDPMD re-certification + establishment licence renewal	Every 3 years	RM5,500	CAB audit RM4,785 per warehouse; MDA licence renewal fee (distributor RM1,200: RM200 application + RM1,000 renewal)
Product registration	Every 5 years	RM6,000	None — all-in: 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: 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. Langkah 1: GDPMD dan lesen establishmen — yuran kami RM5,500; audit CAB (RM4,785 setiap gudang) dan fi lesen MDA (pengedar RM2,250) dibayar terus oleh anda. Langkah 2: pendaftaran produk RM3,800 (Kelas A), RM6,800 (Kelas B), RM9,800 (Kelas C) atau RM12,000 (Kelas D) setiap peranti — sudah termasuk fi CAB dan fi MDA. Langkah 3: tahun pengawasan GDPMD — yuran kami RM2,500 setahun, audit CAB RM2,585 dibayar terus. Pelan bayaran bulanan dari RM1,500 sebulan. WhatsApp 010-206 2070 untuk sebut harga bertulis.

FAQ

Frequently asked questions

Which fees are included, and which do I pay direct?

Device registration is all-in: our professional work, the CAB conformity assessment fee and the MDA statutory fees are inside the per-device price. GDPMD, ISO 13485 and establishment licensing work differently: the certification body’s audit fee and the MDA licence fee are paid by you, direct to the certification body and to MDA — they are not part of our fee. We list those fees next to ours on this page and itemise them in every quotation, 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. 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 surveillance (years 2 and 3): our fee RM2,500 a year, plus the CAB surveillance audit of RM2,585 a year paid direct to the CAB. ISO 13485 surveillance (years 2 and 3): our fee RM4,000 a year, plus the certification body’s RM5,000 a year paid direct. Every 3 years the GDPMD re-certification repeats (our fee RM5,500; CAB audit RM4,785 paid direct) together with the establishment licence renewal, whose MDA fee is paid direct to MDA. Each product registration renews every 5 years (RM6,000, CAB and MDA fees included). 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 quotation showing our fee and every fee paid direct, usually within one working day.

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