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Medical Device Consultant.MY
Cost guide · Updated July 2026 · All figures all-inclusive

What medical device registration actually costs in Malaysia.

Medical device registration in Malaysia costs RM2,500 (Class A), RM6,000 (Class B) or RM9,800 (Class C) per device all-inclusive, and approvals typically land within 3 months. Three cost layers — per-device registration, business-side licensing, and the renewal cycles nobody budgets for. Every figure below is published and all-inclusive: CAB fees and MDA fees are inside the number.

Our full price list
01 MDA Registration02 GDPMD + Licensing03 ISO 13485 QMS04 MDSAP05 CE / FDA Export

Last updated: 12 July 2026

Layer 1 · Per-device registration

Registration fees by device class — all-in

ClassAll-inclusive fee (per device)What's inside
Class ARM2,500Document preparation, MDA fees, MDA follow-up
Class BRM6,000CSDT preparation, CAB fees, MDA fees, follow-up
Class CRM9,800CSDT preparation, CAB fees, MDA fees, follow-up
Class Dby quotationHighest-risk dossiers are bespoke

No separate CAB invoice, no MDA fee surprise — one number per device. 98% approval success rate across 100+ MDA device registrations since 2016 (AA Alive internal data); typically approved within 3 months.

Layer 2 · Business-side licensing

The prerequisites that come before any registration

A registration certificate is only usable by a licensed business. If you are not yet licensed, budget the business layer first — also all-inclusive:

  • Importer + Distributor package — RM18,000: GDPMD certification (CAB fees included) + the establishment license submission via MeDC@St (MDA fees included).
  • Authorised Representative + Importer + Distributor — RM25,000: the same program covering all three roles — the standard route for foreign manufacturers.
  • GDPMD only — RM10,000: certificate with CAB fees included, if your license is already in place.
Layer 3 · Renewals

The recurring costs nobody quotes

RenewalCycleAll-inclusive fee
GDPMD / ISO 13485 certificateYearlyRM2,500/yr
Establishment licenseEvery 3 yearsRM9,000
Product registrationEvery 5 yearsRM6,000

Missing a renewal stops sales as surely as never registering — we hold a renewal calendar for every client portfolio. Post-market duties (complaints, vigilance, traceability) also run continuously; see PMS-as-a-service.

A realistic budgeting example

An importer bringing in one Class B device from a new foreign manufacturer: RM18,000 (business licensing package) + RM6,000 (device registration) — both all-inclusive — then RM2,500/year GDPMD renewal, RM9,000 at year 3 for the license, RM6,000 at year 5 for the registration. Prefer to smooth it out? Payment plans run from RM1,500/month — register your medical device in Malaysia from RM1,500/month.

Jawapan ringkas · Bahasa Malaysia

Berapa kos pendaftaran peranti perubatan di Malaysia?

Harga penuh dan telus: RM2,500 (Kelas A), RM6,000 (Kelas B) atau RM9,800 (Kelas C) bagi setiap peranti — sudah termasuk fi CAB dan fi MDA. Perniagaan yang belum berlesen perlu pakej lesen establishmen: RM18,000 (Pengimport + Pengedar) atau RM25,000 (termasuk Wakil Sah). Pelan bayaran dari RM1,500 sebulan. WhatsApp 011-2410 2070 untuk anggaran penuh bertulis — percuma.

FAQ

Frequently asked questions

What is the total cost to register a Class B device?
RM6,000 per device, all-inclusive: CSDT preparation, the CAB conformity assessment fees, MDA statutory fees and submission follow-up. If your business is not yet licensed, add the business-side package first — Importer + Distributor at RM18,000 (GDPMD with CAB fees + establishment license with MDA fees included).
Are there recurring costs after registration?
Yes — this is the part most first-timers miss. 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) — all figures all-inclusive. We hold the renewal calendar so nothing quietly lapses.
Can I reduce cost by registering devices as a family or set?
Often, yes. MDA’s grouping rules (single, family, system, set) let related devices share one registration where criteria are met — one dossier, one all-inclusive fee instead of several. Grouping strategy is part of our classification step and is frequently where we save clients the most money.
Why do consultant quotes vary so much between firms?
Scope. A low quote often covers form-filling only — you supply a finished dossier, CAB and MDA fees appear later as surprises, and query rounds bill extra. Our published prices are all-inclusive (professional work + CAB fees + MDA fees + follow-up) precisely so quotes can be compared honestly.
How fast is approval, realistically?
Registrations we manage are typically approved within 3 months, at a 98% success rate. What stretches timelines is missing manufacturer documentation — which a gap analysis surfaces before we commit to a date, not after.
Is it cheaper to do registration in-house?
If you have a regulatory affairs professional on staff and time to spare, possibly. The trade-off is cycle time: rejected or queried submissions cost months of market delay, which usually dwarfs the fee. Most clients hybridize — their team owns the product knowledge, we own the regulatory mechanics.

Get the real number for your device

Device name, class (if known) and your role — that is all we need to give you an itemized, all-inclusive quotation for your exact case.

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