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MDA · Circular 3/2022 · MDA/GD/0060 · MDA/GD/0029 GRPMD

Refurbished and used medical devices in Malaysia.

Refurbished imaging systems, ventilators and monitors are a big market in Malaysia, and since 2022 every type of refurbishment has been regulated under Act 737. Whoever refurbishes and sells the device becomes its manufacturer, with the licence, registration and labelling duties that come with that.

Establishment licence
01 MDA Registration02 GDPMD + Licensing03 ISO 13485 QMS04 MDSAP05 CE / FDA Export
The rules

Three documents govern refurbishment.

  • Circular Letter No. 3/2022, Refurbishment of Medical Device (9 May 2022), which revoked Circular 1/2016: “all types of refurbishment, not only limited to full refurbishment activities” are regulated under Act 737.
  • MDA/GD/0060, Refurbished Medical Device – Requirements (First Edition, 2022): who registers, and how.
  • MDA/GD/0029, Good Refurbishment Practice of Medical Device (GRPMD) (January 2016): how refurbishment is done. It excludes reprocessing of single-use devices and remanufacturing.

MDA defines a used device as one that has been in service, taken out of service and put back into service, usually somewhere else.

Who does what

Refurbished byLicenceRegistrationOther duties
Original manufacturer, device already registeredExistingNo new registration listedRefurbishment in QMS scope; GRPMD; refurbished labelling
Original manufacturer, device not registeredExistingRegister via MeDC@St after CAB assessmentRefurbishment in QMS scope; GRPMD; technical details
Third party (local)Establishment licence as manufacturerRegister after CAB assessmentGRPMD; may not use the original brand name
Third party (foreign)Appoint a Malaysian authorised representativeRegister after CAB assessmentGRPMD; may not use the original brand name

Act 737 counts anyone who fully refurbishes, reprocesses or labels ready-made devices under their own name as a manufacturer, and GRPMD holds the refurbisher liable. A refurbished device whose intended use or specifications change is treated as a new device. Maintenance follows MS 2058.

Labelling a refurbished device

  • The word “Refurbished”.
  • A catalogue number different from the new device, with an [R] suffix.
  • The refurbishment date (MDA/GD/0026, 7th Edition, section 4.9).
  • Everything else a Malaysian label needs: see labelling requirements.

Importing used equipment

MDA has no specific ban on importing used devices, and no circular specific to it. The general rules apply:

  • The device must be registered (Act 737 section 5).
  • The importer must hold an establishment licence (section 15).
  • Each offence carries up to RM200,000 and/or 3 years.
  • MDA’s import permit (Customs (Prohibition of Imports) Order 2023, RM130 per application) is enforced from 1 July 2027.

If the equipment is refurbished before it is sold, the importer or refurbisher takes on the manufacturer duties above.

Donations, and orphaned or obsolete devices

Act 737 defines placing on the market to include supplying a device free of charge, new or reprocessed, so a donated device is treated like a sold one for registration. Separately, Circular 2/2022 exempts orphaned, obsolete and discontinued devices already placed on the market from registration and licensing; the risk rests with the establishment, users and facility. An obsolete device that has never been registered and is to be placed on the market still needs registration. Users must keep devices safe, installed, tested and maintained, and dispose of retired devices so they cannot be reused (section 43).

Refurbishers and traders who hold stock for distribution also need GDPMD: see GDPMD certification.

Jawapan ringkas · Bahasa Malaysia

Bolehkah peranti perubatan terpakai atau diperbaharui dijual di Malaysia?

Boleh, jika mematuhi Akta 737. Pekeliling Bil. 3/2022 menetapkan semua jenis pembaharuan (refurbishment) dikawal di bawah Akta 737. Pihak ketiga yang memperbaharui peranti dianggap pengilang: perlu lesen establismen sebagai pengilang, pendaftaran peranti selepas penilaian CAB, dan label “Refurbished” dengan nombor katalog berakhiran [R] (MDA/GD/0060). WhatsApp 010-206 2070.

FAQ

Frequently asked questions

Can refurbished medical devices be sold in Malaysia?
Yes, if they comply with Act 737. MDA Circular Letter No. 3/2022 (9 May 2022) states that all types of refurbishment, not only full refurbishment, are regulated under Act 737. The refurbished device must be registered, the refurbisher must follow Good Refurbishment Practice (MDA/GD/0029), and the label must say “Refurbished”.
Who is the manufacturer of a refurbished device?
Act 737 counts anyone who fully refurbishes, reprocesses or labels ready-made devices under their own name as a manufacturer. A third-party refurbisher placing a refurbished device on the market is therefore the manufacturer. A local refurbisher needs an MDA establishment licence as a manufacturer; a foreign refurbisher must appoint a Malaysian authorised representative. A third party may not use the original manufacturer’s brand name.
Does a refurbished device need a new registration?
It depends who refurbishes it. If the original manufacturer refurbishes a device that is already registered, MDA’s table lists no new registration or CAB step, but refurbishment must be in its QMS scope and labelling rules apply. A third-party refurbisher, or a manufacturer refurbishing an unregistered device, must register it through MeDC@St after CAB conformity assessment. A device whose intended use or specifications change is treated as a new device.
How must a refurbished device be labelled?
With the word “Refurbished”, a catalogue number different from the new device with an [R] suffix (Circular 3/2022 and MDA/GD/0060), the refurbishment date (MDA/GD/0026, 7th Edition), and all the usual Malaysian label contents such as the registration number and authorised representative details.
Can we import used or second-hand medical equipment?
MDA has no specific ban on importing used devices, but the general rules apply: the device must be registered (Act 737 section 5) and the importer must hold an establishment licence (section 15), each an offence carrying up to RM200,000 and/or 3 years. If it is refurbished before sale, the refurbishment rules apply too. MDA’s import permit under the Customs (Prohibition of Imports) Order 2023 is enforced from 1 July 2027.
Can a hospital donate or sell its used equipment?
Act 737 defines placing on the market to include supplying a device free of charge, whether new or reprocessed, so a donation is treated like a sale for registration purposes. Separately, MDA Circular 2/2022 exempts orphaned, obsolete and discontinued devices already placed on the market from registration and licensing, with the risk resting on the establishment, users and facility, and users must still keep them safe and maintained under section 43.

Trading or refurbishing used equipment?

Tell us what you refurbish or import and whose name goes on it. We will map the licence, registration, CAB and labelling steps under Circular 3/2022 and MDA/GD/0060.

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