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AA Alive Sdn Bhd · SSM 1204108-DMDA-licensed practiceSuperbrands Malaysia 20251,000+ devices registered
ISO 13485.MY
Fees · Published · Our fee and pay-direct fees, shown apart

MDA registration fees in Malaysia: every 2026 fee, in writing.

Product registration is RM3,800–RM12,000 per product, with CAB and MDA fees included and approvals typically within 3 months. For GDPMD, ISO 13485 and establishment licensing we show our fee and, separately, the certification-body and MDA fees you pay direct — structured as the three gates every device business actually passes through.

ISO 13485 or GDPMD?

Last updated: 18 September 2026

The short answer

How much does MDA registration cost in Malaysia?

It comes in two parts: getting the company legal — a certified quality system plus an MDA establishment licence — and then registering each product. The spread depends on your role in the supply chain and how many products you register.

What you are paying forWhenOur feePaid direct by you
ISO 13485 + MDA manufacturer licenceyear 1RM7,500RM7,500 ISO 13485 certification audit — paid direct to the certification body · RM4,250 MDA manufacturer licence (RM250 application + RM4,000 licence) — paid direct to MDA
GDPMD + MDA establishment licenceyear 1RM5,500RM4,785 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)
GDPMD certification onlyyear 1RM5,500RM4,785 GDPMD certification audit, per warehouse — paid direct to the certification body
Product registration, Class A → DOne-off, per productRM3,800 – RM12,000Nothing — CAB + MDA fees included
GDPMD surveillance auditper year, years 2 and 3RM2,500RM2,585 GDPMD surveillance audit, per warehouse — paid direct to the certification body
ISO 13485 surveillance auditper year, years 2 and 3RM4,000RM5,000 ISO 13485 surveillance audit — paid direct to the certification body
Product registration renewalevery 5 years, per productRM6,000Nothing — CAB + MDA fees included

For product registration, MDA's statutory fees and the CAB fees are inside our price. For GDPMD, ISO 13485 and the establishment licence they are not: the certification body and MDA are paid by you directly, and we list each amount beside our fee so it is in your budget from the start. When comparing quotations, compare our fee with the other consultant's fee, and the pay-direct fees separately. The one cost no one can quote blind is bringing your premises and processes into physical compliance — that is what the opening gap analysis is for.

Not sure which row applies to you? The ISO 13485 vs GDPMD comparison settles it in about two minutes, and filing happens through MeDC@St either way.

For comparison

What MDA itself charges

Our product-registration fees already contain the government's. It is worth seeing the two apart, because “MDA registration fees” means two different things depending on who is saying it — the statutory fee the Medical Device Authority collects per device, and what it costs to actually get a device registered. The first is fixed by regulation and identical for everyone. The second is the dossier work, and it is where the real money and the real risk sit.

Risk classMDA application feeMDA registration feeOur all-in price
Class A (low risk)RM500RM750RM3,800
Class B (low–moderate)RM500RM1,000RM6,800
Class C (moderate–high)RM750RM2,000RM9,800
Class D (high risk)—RM3,000RM12,000

Statutory fees per the Table of Fees, Part IV, Fifth Schedule, Medical Device Regulations 2012. Class A changed on 1 January 2026 — the application fee rose from RM100 to RM500 and a RM750 registration fee was introduced, under the Medical Device (Amendment) Regulations 2025 [P.U.(A) 330], gazetted 11 September 2025. Confirm the current schedule against MDA before you budget; we re-check it at every submission and the amount is inside our product-registration price either way.

Two things follow from this table. The statutory fee is the smaller part of the cost — RM1,250 of MDA charges on a Class A device against the classification review, CSDT dossier, labelling check and query handling that get it approved. And because product registration is priced all-in, there is no second invoice from MDA or the CAB for it.

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.

ISO 13485 + MDA MANUFACTURER LICENCE

ISO 13485 + MDA manufacturer licence

RM7,500 our fee · year 1

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

You manufacture devices — including assembling, relabelling or sterilising them under your name.

  • 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
Start this package
GDPMD + MDA ESTABLISHMENT LICENCE

GDPMD + MDA establishment licence

RM5,500 our fee · year 1

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).

You import, distribute or act as authorised representative, and need the certificate and the 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
Start this package
GDPMD CERTIFICATION ONLY

GDPMD certification only

RM5,500 our fee · year 1

Not included in our fee — you pay these direct:
+ RM4,785 GDPMD certification audit, per warehouse — paid direct to the certification body

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

  • 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
Start this package

Our 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. Surveillance and renewal years are in the renewals table below.

Step 2 · Register your devices

Product registration (one-off, per product)

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-in fee (CAB + MDA fees included)Included
Class ALowest risk. Most non-sterile, non-measuring instruments.RM3,800Document preparation, MDA fees, Follow-up on MDA enquiries
Class BLow to moderate risk.RM6,800CSDT 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.RM12,000Classification review — we tell you which class your device falls in, CSDT dossier preparation, CAB fees and MDA fees, Follow-up on MDA enquiries

Multi-product packages

PackageProductsAll-in fee (CAB + MDA fees included)
Class A package5RM12,000
Class B package3RM18,000
Class C package3RM25,000
Class D package3RM30,000

Package prices are all-in, CAB and MDA fees included. The number of registrations is subject to MDA grouping rules and confirmation of product configurations, intended uses and model variants. 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 audited every year, the establishment licence is renewed every three years, and each product registration every five years.

RenewalCycleOur feePaid direct by youIncluded
GDPMD surveillance auditper year, years 2 and 3RM2,500RM2,585 GDPMD surveillance audit, per warehouse — paid direct to the certification bodySite review, feedback and adjustment, Documents preparation review
ISO 13485 surveillance auditper year, years 2 and 3RM4,000RM5,000 ISO 13485 surveillance audit — paid direct to the certification bodyInternal audit, Documents preparation review
GDPMD re-certification + establishment licence renewalyear 4, then every 3 yearsRM5,500RM4,785 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 directFull 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 renewalyear 4, then every 3 yearsRM5,000RM7,500 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 MDAPMS and CAPA development, internal audit, training, system review and update
Product registration renewalevery 5 years, per productRM6,000Nothing — CAB + MDA fees includedDocument preparation, including product return records, CAB fees and MDA fees, Follow-up on MDA enquiries
Payment terms

How you pay

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, cash-flow-friendly. Ask for the payment plan option in your quotation. The certification body's audit fee and MDA's licence fees are paid by you directly to them when they fall due — they never pass through our invoice, and we never add them into our fee.

Quoted separately

Export programmes — MDSAP, CE marking (EU MDR) and FDA 510(k) — are handled by our device regulatory flagship, medicaldeviceconsultant.my. Quotations are itemised: our fee, and each fee paid direct, on separate lines.

Jawapan ringkas · Bahasa Malaysia

Berapa kos untuk daftar 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 — Langkah 2. Sebelum itu, Langkah 1: yuran kami untuk GDPMD dan lesen establishmen ialah RM5,500 bagi tahun pertama, manakala fi audit badan pensijilan (RM4,785 setiap gudang) dan fi lesen MDA (RM2,250 untuk pengedar) anda bayar terus kepada mereka. ISO 13485: yuran kami RM7,500, dengan fi badan pensijilan RM7,500 dan fi lesen pengilang MDA RM4,250 dibayar terus. Langkah 3: tahun pengawasan GDPMD RM2,500 (yuran kami) dan RM2,585 dibayar terus kepada badan pensijilan. Terma standard: 50% pada permulaan, 50% selepas kelulusan; pelan bayaran bulanan dari RM1,500 sebulan juga tersedia. WhatsApp 010-206 2070 untuk sebut harga bertulis.

FAQ

Frequently asked questions

Are CAB and MDA fees included?
For product registration, yes: the per-product fees (Class A RM3,800 to Class D RM12,000) include the CAB conformity assessment and MDA’s submission and approval fees, so you pay us and nobody else. For GDPMD, ISO 13485 and establishment licensing, no: the certification body’s audit fee and MDA’s licence fee are paid by you directly to them, and we state each one beside our fee rather than inside it. What is never included is the cost of physically bringing your premises and processes into compliance — nobody can quote that sight unseen, which is why every engagement starts with a gap analysis.
How is payment structured?
Our standard terms: our fee is payable 50% to start, 50% on approval or completion. Instead, you can spread our fee 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, and details and eligibility are confirmed in the written quotation. Fees paid direct — the certification body’s audit and MDA’s licence fees — are paid by you to those bodies when they fall due, not through us. Every figure is confirmed in a written quotation before you commit.
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: the GDPMD or ISO 13485 certificate has a surveillance audit in years 2 and 3 and re-certification in year 4; the establishment licence renews every three years; and each product registration renews every five years (RM6,000 per product, all-in: CAB and MDA fees included). A GDPMD surveillance year is RM2,500 in our fee plus RM2,585 paid direct to the certification body; an ISO 13485 surveillance year is RM4,000 plus RM5,000 paid direct to the certification body. In year 4 the certification fee repeats and MDA’s licence renewal fee is paid direct to MDA. We hold the renewal calendar for every client so nothing quietly lapses.
What does ISO 13485 implementation itself cost?
Our fee for ISO 13485 is RM7,500 in year 1, and it is sold together with the MDA manufacturer licence application. Two fees are paid by you directly: the certification body’s audit, RM7,500, and MDA’s manufacturer licence fee, RM4,250 (RM250 application + RM4,000 licence). The gap analysis that opens every engagement confirms the scope in a written quotation before you commit.
What are MDA’s own registration fees?
The Medical Device Authority charges a statutory fee per device under the Fifth Schedule of the Medical Device Regulations 2012: Class A RM500 application plus RM750 registration, Class B RM500 plus RM1,000, Class C RM750 plus RM2,000, and Class D RM3,000 registration. Class A changed on 1 January 2026 under the Medical Device (Amendment) Regulations 2025 [P.U.(A) 330] — the application fee was RM100 before that and there was no registration fee. These are the government’s charges only, and they are already included in our per-product prices of RM3,800 to RM12,000.
How much does MDA registration cost in Malaysia?
Registering each product costs RM3,800 (Class A), RM6,800 (Class B), RM9,800 (Class C) or RM12,000 (Class D) with us, CAB and MDA fees included. Before any product can be registered, the company needs a certified quality system and an establishment licence: for an importer or distributor our fee is RM5,500 in year 1, and the certification body’s GDPMD audit (RM4,785 per warehouse) and MDA’s licence fee (RM2,250 for a distributor) are paid by you directly to them. Multi-product packages are also all-in: five Class A products RM12,000, or three products at RM18,000 (Class B), RM25,000 (Class C) or RM30,000 (Class D).
How much does GDPMD certification cost?
Our fee for GDPMD is RM5,500 in year 1, and the certification body’s audit — RM4,785 per warehouse — is paid by you directly to the certification body. If you also need the MDA establishment licence, our fee stays RM5,500 and MDA’s licence fee is paid direct to MDA: RM2,250 for a distributor (RM250 application + RM2,000 licence), with other licence roles carrying their own MDA fee. Surveillance years 2 and 3 are RM2,500 in our fee plus RM2,585 paid direct to the certification body.
Are there MDA fees on top of your price?
For product registration, no — the CAB and MDA fees are inside the per-product price. For GDPMD, ISO 13485 and establishment licensing, yes: the certification body’s audit and MDA’s licence fee are paid by you directly to those bodies, and we list each amount beside our fee so you can budget for it. When you compare quotations, compare our fee with theirs, and the pay-direct fees separately.

Want this as a written quotation?

Tell us your role, device classes and target markets — you will get an itemised quotation, with our fee and every fee paid direct on separate lines.