Act 737 · Importer licence · GDPMD · Import permit from 1 July 2027

Import medical devices into Malaysia: licensed, registered and ready for the 2027 import permit.

For companies bringing medical devices or medical equipment into Malaysia to sell. We certify your warehouse to GDPMD, get the importer (and distributor) licence, make sure every device is registered through an authorised representative, and set up the import permit before enforcement starts.

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Short answer: to import medical devices into Malaysia for sale you need a Malaysian company with a GDPMD-certified warehouse, an MDA importer licence (MDA charges RM250 + RM2,000), and an MDA registration for every device, held by the manufacturer’s authorised representative. From 1 July 2027 each shipment also needs an MDA import permit (RM130). We set up the licence and GDPMD for RM5,500 our fee; registrations are all-in from RM3,800 per device.

Checklist

What an importer needs, in order

Step	What it is	MDA or CAB fee	Who handles it
1. Malaysian company	An establishment must be resident in Malaysia or a company constituted under Malaysian law (Act 737, s.2)	SSM fees	You (we advise on roles before you incorporate)
2. GDPMD certificate	Good Distribution Practice for Medical Devices, audited by a CAB at your warehouse	CAB audit RM4,785 per warehouse	Us: documentation, training, audit day
3. Importer licence	MDA establishment licence for the importer role; add a distributor licence if you also sell on to others	RM250 + RM2,000 per licence (renewal RM200 + RM1,000)	Us: MeDC@St application, 14–21 working days
4. Device registration	Every device registered under s.5, held by the manufacturer’s authorised representative	MDA RM1,250–RM3,750 per device, plus CAB for Class B–D	Us, all-in RM3,800–RM12,000 per device
5. Import permit	Per-shipment permit through ePermit, enforced from 1 July 2027	RM130 per application	You or your forwarder; we set up access and the first applications
6. Post-market duties	Distribution records, complaints, mandatory problem reporting, recalls	None	You, or us on a PMS retainer

The question that decides the cost

Are the devices already registered in Malaysia?

An importer does not need its own registration for a device that is already registered, but it does need the registration to exist, and someone to hold it. There are three situations:

Registered, and the manufacturer has an AR here. You need GDPMD and your licence(s), plus an agreement with that AR. Fastest and cheapest.
Not registered, and you want to control it. Your company becomes the manufacturer’s AR (a separate AR licence, MDA fee RM250 + RM4,000) and registers each device. You hold the registrations, so you hold the market.
Not registered, and you would rather not be the AR. We act as the manufacturer’s AR under our own MDA establishment licence and register the devices; you import and distribute. Switching AR later is a change of ownership under MDA/GD/0041.

Devices with approval from a recognised regulator can go through the cheaper verification route at the CAB stage; devices on the Singapore register use the HSA route. Chinese NMPA approval alone is not on MDA’s recognised list, so those devices need full conformity assessment.

Imports that do not need registration

The Medical Device (Exemption) Order 2024 covers imports that never reach the open market. Most need an application to MDA first:

Personal use: no application, home-use devices only, in small quantities (for example 1 blood pressure monitor, or 3 months of IVD test strips).
Special access: an unregistered device for a named need; RM300, 7 working days, letter valid 6 months.
Demonstration and exhibitions: demo units and trade-show samples, RM300.
Import for re-export: repair, testing, relabelling or a regional hub; apply at least 21 days before import (MDA/GD/0069).

Importing from a country without diplomatic ties with Malaysia adds a customs approved permit before MDA will consider the registration (Circular Letter No. 1/2024).

Fees: our fee, and the fees you pay direct

Item	Our fee	Paid direct (not included)
GDPMD + importer (and distributor) licence submissions (year 1)	RM5,500	CAB GDPMD audit RM4,785 per warehouse; MDA RM2,250 per importer or distributor licence; AR licence RM4,250
GDPMD surveillance (years 2 and 3)	RM2,500/yr	CAB surveillance audit RM2,585/yr
GDPMD re-certification + licence renewal (every 3 years)	RM5,500	CAB audit RM4,785 per warehouse; MDA renewal RM1,200 per importer or distributor licence
Device registration, per device (all-in)	RM3,800 (A) · RM6,800 (B) · RM9,800 (C) · RM12,000 (D)	None: CAB and MDA fees included
Authorised representative for the foreign manufacturer	Annual retainer, quoted per portfolio	None

Payment plans from RM1,500 a month. Quotations are itemised and usually issued within one working day.

Records start with the first shipment

Once you import, you are a duty holder under the Medical Device (Duties and Obligations of Establishments) Regulations 2019: distribution records that trace each device to the customer, complaint handling, mandatory problem reporting and field corrective actions. MDA’s draft Second Edition of its Distribution Records guidance (the current text is MDA/GD/0012, First Edition, June 2020) was opened for public comment from 3 to 18 November 2026. It adds definitions including UDI and field corrective action, and tighter traceability for implantable devices down to the healthcare facility and patient. If you import implants, set up lot and patient-level traceability now rather than after the final edition is published.

Jawapan ringkas · Bahasa Malaysia

Apa yang diperlukan untuk mengimport peranti perubatan ke Malaysia?

Syarikat Malaysia dengan gudang yang diperakui GDPMD, lesen establismen pengimport MDA (fi MDA RM250 + RM2,000) dan pendaftaran MDA bagi setiap peranti, dipegang oleh wakil sah (authorised representative) pengeluar. Mulai 1 Julai 2027 setiap penghantaran memerlukan permit import MDA (RM130). Yuran kami untuk GDPMD dan lesen ialah RM5,500; audit CAB dan fi MDA dibayar terus. WhatsApp 010-206 2070.

FAQ

Frequently asked questions

Do I need a licence to import medical devices into Malaysia?

Yes, for commercial imports. An importer is an establishment under Act 737, and section 15(1) says no establishment shall import a registered medical device without an establishment licence: up to RM200,000, 3 years in prison, or both. MDA charges RM250 to apply plus RM2,000 for the importer licence. If you also sell to hospitals or other sellers, that is a separate distributor licence (one licence per role since 1 July 2024). GDPMD certification of your warehouse comes first.

Can I import a medical device that is not registered in Malaysia?

Not to sell it. Section 5 of Act 737 requires registration before a device is imported, exported or placed on the market. The Medical Device (Exemption) Order 2024 allows specific cases without registration: personal use, special access for a named patient or facility, demonstration and exhibitions, clinical research, import for re-export, custom-made devices and a few others. Most need an application to MDA first. Personal-use import needs no application but is limited to home-use devices in small quantities.

Who registers an imported device, the importer or the manufacturer?

The registration is held by the manufacturer’s authorised representative (AR) in Malaysia, because a foreign manufacturer cannot hold it itself. Either your company becomes the manufacturer’s AR (a separate AR licence, MDA fee RM250 + RM4,000) and holds the registration, or you import devices already registered by the manufacturer’s existing AR, in agreement with that AR. We can also act as the AR ourselves, under our own MDA establishment licence.

Is the medical device import permit required now?

Not yet. MDA postponed enforcement from 2 January 2026 to 1 July 2027 (announcement of 1 December 2025); until then existing customs procedures apply. From 1 July 2027 each shipment needs a permit through the ePermit system: RM130 per application, submitted at least 7 days before shipment, processed within 3 working days. The permit does not replace the licence or the registration.

How long does it take to start importing?

GDPMD certification of the warehouse usually takes longer than the licence itself. MDA then processes a complete licence application in 14–21 working days. If the devices still need registering, that runs in parallel: on our last 39 new registrations the median was 53 days from submission to approval, with Class B–D also needing a CAB conformity assessment before submission.

How much does it cost to become a medical device importer in Malaysia?

Our fee is RM5,500 for GDPMD and the licence submissions. Paid direct by you: the CAB’s GDPMD audit (RM4,785 per warehouse) and MDA’s fee per licence (importer or distributor RM2,250 each; authorised representative RM4,250). Device registration, if needed, is all-in per device: RM3,800 (Class A) to RM12,000 (Class D), CAB and MDA fees included. Payment plans from RM1,500 a month.

What records does an importer have to keep?

Distribution records that trace every device to the customer, complaint records, and the mandatory problem reports and field corrective actions those trigger, under the Medical Device (Duties and Obligations of Establishments) Regulations 2019 and MDA/GD/0012. MDA opened a draft Second Edition of the Distribution Records guidance for public comment from 3 to 18 November 2026; it adds definitions including UDI and tighter traceability for implantable devices down to the healthcare facility and patient level.

Bringing a device range into Malaysia?

Tell us the brand, the devices and who you will sell to. We map the licences, the registrations and the AR set-up, with MDA's fees and ours listed separately.

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