What medical device registration actually costs in Malaysia.

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

Registration fees by device class — all-in

No separate CAB invoice, no MDA fee surprise — one number per device. MDA queries and resubmissions are handled inside the fee, not billed afterwards. 1000+ MDA device registrations since 2016; typically approved within 3 months.

Need only the fee list? Every MDA registration fee, with our fees and the fees paid direct, is kept on one published price list on our sister site, iso13485.my. This guide covers the full budget around it.

What an inclusive registration quote covers

Ask what the MDA registration fee is and you will usually get a single number back, which is where budgets go wrong. Registering a device in Malaysia has three separate cost components, and only one of them is paid to the MDA:

• The MDA statutory fee — the government fee paid to the Medical Device Authority when the application is lodged through MeDC@St. It varies by device class and is set by the MDA, not by any consultant.
• The CAB conformity assessment fee — paid to the registered Conformity Assessment Body that reviews your CSDT dossier before MDA will consider the application. Class A devices do not require one, which is the main reason Class A is the cheapest class to register.
• The consultant fee — the professional work: classification and grouping strategy, CSDT preparation, submission, and answering MDA queries through to approval.

A quote that names only the MDA fee is not a quote for getting registered — it is a quote for one line of the eventual invoice. The figures in the table above are the total of all three: RM3,800, RM6,800, RM9,800 and RM12,000 are what leaves your account, not a starting point. We itemise the three components in every written quotation, so you can see exactly which portion is statutory and which is ours.

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. Here our fee and the fees you pay direct are separate — the direct fees are not part of our fee:

• Our fee — RM5,500 (year 1): GDPMD certification + the establishment license submission via MeDC@St. The same fee applies to GDPMD alone if your license is already in place.
• Paid direct to the CAB — RM4,785 per warehouse: the GDPMD certification audit.
• Paid direct to MDA — the licence fee for each role: RM2,250 for a distributor (RM250 application + RM2,000 licence); authorised representative and importer licences carry their own MDA fees — the AR role is the standard route for foreign manufacturers.

The recurring costs nobody quotes

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 worked budget: one Class B device

This is an illustrative budget using our published fees, not a client case study.

A distributor adding one Class B device from a new foreign manufacturer. Payable to us upfront: RM5,500 (GDPMD and the establishment licence submission) + RM6,800 (device registration, CAB and MDA fees included) = RM12,300. Paid direct, not to us: RM4,785 to the CAB for the GDPMD audit and RM2,250 to MDA for the distributor licence. Then, in years 2 and 3, our fee of RM2,500 a year plus the CAB's RM2,585 a year paid direct; every 3 years the GDPMD re-certification and licence renewal; 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.

One thing that can genuinely reduce a Class B–D bill.

Since 1 March 2026, a Class B, C or D device already listed on the Singapore Medical Device Register can go through MDA's Verification Route (guidance MDA/GD/0070), where the CAB verifies the existing HSA approval instead of performing a full conformity assessment. The CAB fee is the single largest component of the Class B and Class C numbers above, which is precisely why this is the one lever with real money behind it.

Our published per-device prices do not change — we do not sell a separate “verification” product. Where the route reduces the CAB fee for your device, the reduction is itemised in your written quotation. Where it does not, you pay the same all-inclusive number as anyone else. See the Verification Route guide for what it does and does not waive. Note that it does not touch the business-side layer: the establishment licence and GDPMD costs above are unaffected.

One cost that is not arriving as soon as many budgets assume: the medical device import permit (RM130 per application) was postponed from 2 January 2026 to 1 July 2027, so it is not a 2026 line item.

Exporting rather than importing? The overseas routes price differently — a US FDA 510(k) submission and CE marking under EU MDR each run on their own fee schedules, quoted separately from the Malaysian figures above.