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Is This Ultrasound MDA-Registered? A Buyer’s Checklist

Every diagnostic ultrasound system and probe sold in Malaysia must be registered with the Medical Device Authority. How to check a number in a few minutes, what the seller must hold, and what MDA’s planned hologram label means for buyers.

Also called MDA registered ultrasound, MDA registration check, Medical device register

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What the law requires

Under the Medical Device Act 2012 (Act 737), a medical device must be registered with the Medical Device Authority (MDA) before it is imported, exported or placed on the Malaysian market. Diagnostic ultrasound systems and their transducers are medical devices, whether they are new, refurbished, rented or second hand. Section 15 of the Act adds that the company placing a device on the market must hold an MDA establishment licence. Selling unregistered devices is an offence; enforcement reports cite fines of up to RM200,000, up to three years in jail, or both.

Device registration

Covers the device itself — the system and, depending on how the maker registered it, each probe. Registrations have expiry dates, so a number that was valid when a model launched may have lapsed since.

Establishment licence

Held by the manufacturer, importer, distributor or authorised representative that places the device on the market. Retailers are outside this licence, but whoever brought the device into Malaysia must hold one.

Risk class

The Medical Device Regulations 2012 sort devices into Classes A to D by risk. Diagnostic ultrasound scanners are usually Class B, low to moderate risk, so a conformity assessment body reviews them before MDA registers them. The class of a particular system depends on its intended use.

How to check a registration number

  • Ask the seller in writing for the MDA registration number of the system and of each probe on the quotation.
  • Open the public search of the Malaysia Medical Device Register at mdar.mda.gov.my.
  • Search by registration number, or by brand name or establishment name if you do not have the number.
  • Check that the brand, model and probe names on the record match the quotation, and that the establishment named is the seller or its supplier.
  • If nothing comes up, the register states that the device is unregistered, expired, suspended or cancelled. Ask the seller to explain before you pay.
  • Save a dated screenshot of the record and keep it with the invoice and installation report.

Read next Comparing ultrasound quotations

Probes, used units and accessories

Probes

Probes are often covered by the same registration as the system, but not always. A probe bought later, from a third party or for an older platform should have its own match on the register.

Probe repair and replacement

Refurbished and second-hand units

A used scanner sold in Malaysia is still a medical device under Act 737. Check that the model is on the register, and be wary of units brought in privately from overseas with no local importer behind them.

Buying refurbished ultrasound

Rental and loan units

A rented or loaned system is placed on the market just as a sold one is, so ask for the same registration numbers.

Renting an ultrasound machine

Gel, covers and disinfectants

Ultrasound gel, probe covers and disinfectants can be medical devices in their own right, with their own registrations. Ask about them too, especially sterile covers used for procedures.

MDA’s hologram security label

In early August 2026 the MDA announced a hologram security label for registered medical devices, modelled on the Farmatag hologram that has marked registered medicines since 2005. MDA describes it as a way to strengthen post-market controls, protect the supply chain and protect consumers, and says it will be rolled out in phases.

  • As of mid-October 2026, MDA had not published the list of device categories, the technical requirements or a start date.
  • Regulatory consultants reported in early October 2026 that implementation is not expected before 2027 and is likely to cover selected device categories first.
  • It is not yet known whether ultrasound systems and probes will be in the first phase. Until a label is required, the register search is the check that counts.
  • A hologram will not replace the paperwork. Keep asking for registration numbers and the establishment licence.

Other 2026 change: aesthetic devices

Since 1 June 2026, the Medical Device (Designated Medical Device) Order 2026, P.U.(A) 10/2026, has brought certain aesthetic devices under Act 737 — reported to include lasers, HIFU and liposuction systems. It matters to aesthetic clinics that own HIFU units. Diagnostic scanners were already medical devices, so for them nothing changes.

Read next Diagnostic ultrasound vs HIFU and therapy unitsDiagnostic ultrasound in aesthetic clinics

Red flags in a quotation

  • No registration number, or a number that belongs to a different model or probe.
  • A model name that does not appear on the register under that brand.
  • A seller who will not name the importer or the establishment licence holder.
  • Probes described only as “compatible”, with no brand or registration.
  • Pressure to pay before you have had time to check.

Read next Ultrasound brands in MalaysiaRed flags when buying used

Related guides

Ultrasound Machine Price in Malaysia: What Drives the CostWe do not publish a price list, because the right figure depends on the platform and probes you need. Here is what moves the price and how to compare quotes.Ultrasound Machine Brands in Malaysia and How to Compare ThemA neutral map of the ultrasound brands Malaysian clinics are offered, and the questions that matter more than the logo.Refurbished Ultrasound Machine: How to Buy Second Hand SafelyA used or refurbished ultrasound can be good value — or an expensive problem. These are the checks that separate the two.

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Frequently asked questions

How do I check if an ultrasound machine is MDA registered?
Ask the seller for the registration number of the system and each probe, then search it on the Malaysia Medical Device Register at mdar.mda.gov.my. If it does not appear, the device may be unregistered, expired, suspended or cancelled.
What class of medical device is an ultrasound scanner in Malaysia?
Diagnostic ultrasound scanners are usually Class B, low to moderate risk, under the Medical Device Regulations 2012. The class of a particular system depends on its intended use, which the registration holder can confirm.
Is the MDA hologram label required on ultrasound machines?
Not yet. MDA announced the hologram in August 2026 but, as of mid-October 2026, had not published which devices it covers or when it starts. Industry reports suggest it will not begin before 2027.
Who must hold an MDA establishment licence?
The manufacturer, importer, distributor or authorised representative that places a device on the Malaysian market. Retailers are excluded, but the company that brought the device into Malaysia must be licensed.

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