What counts as a medical device in Malaysia.

The definition in two tests.

Under section 2 of the Medical Device Act 2012 (Act 737), a product is a medical device if it passes two tests. First, the manufacturer intends it to be used on human beings for one of seven medical purposes. Second, it does not achieve its primary intended action in or on the body by pharmacological, immunological or metabolic means, although such means may assist it. The Minister may also declare other articles used on the human body to be medical devices by order in the Gazette, on grounds of public safety, health or risk.

MDA explains the definition in MDA/GD/0006, Definition of Medical Device (Second Edition, 30 March 2026). The definition was adopted from the Global Harmonization Task Force (GHTF) recommendation, so it reads much like the definitions used by other regulators. MDA/GD/0006 also sets out how MDA treats accessories, components and spare parts, a question every importer of equipment eventually asks.

Test 1: one of seven medical purposes

The article can be an instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or a similar or related article, used alone or in combination. The manufacturer must intend it for:

1. diagnosis, prevention, monitoring, treatment or alleviation of disease;
2. diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
3. investigation, replacement, modification or support of the anatomy or of a physiological process;
4. supporting or sustaining life;
5. control of conception;
6. disinfection of medical devices; or
7. providing information for medical or diagnostic purposes by in vitro examination of specimens derived from the human body.

The seventh purpose brings in vitro diagnostics under the Act. MDA’s note to the definition lists reagents, calibrators, sample collection and storage devices, control materials and the related instruments (see IVD registration). A second note says aids for disabled people, accessories, disinfection substances and devices incorporating animal or human tissue may also be medical devices, the last subject to different controls. Software qualifies on the same purposes; see software as a medical device.

“Intended by the manufacturer”: claims decide

The definition turns on the manufacturer’s intended purpose, which MDA reads from the labelling, advertising and documentation. The same physical product can fall either side of the line:

• Face masks and respirators. MDA/GD/0033 says a mask is a medical device when the manufacturer claims it prevents disease transmission or is for surgical or clinical use. A mask for construction or industrial use is personal protective equipment outside MDA’s control.
• Gloves, gowns and other PPE. MDA/GD/0058 applies the same rule. MDA’s FAQ adds that medical gloves are usually labelled “surgical” or “examination”, and that “medical use” on the outer box must match an intended use that fits section 2. Our face mask and PPE page has the standards.
• Wearables. ASEAN’s borderline list (MDA/GD/0063) treats a wristwatch that tracks steps and heart rate for daily life as a non-medical device, and one that measures oxygen saturation, blood glucose, blood pressure or ECG as a medical device.
• Oxygen. The same list treats medical gases, with their primary containers, as drugs, and recreational canned oxygen as a non-medical device. The pipelines, terminal units and empty cylinders that deliver medical gases are devices: see medical gas systems.

Test 2: the primary mode of action

The second limb keeps medicines out. A device may be assisted by a drug-like action, but its primary intended action must not be pharmacological, immunological or metabolic. MDA/GD/0006 defines the three terms:

Products that sit across the line, such as drug-coated devices or device-delivered drugs, go to NPRA or MDA under the MOH Combination Product Guideline. Our combination products page covers that allocation.

Device, accessory, component or spare part

MDA/GD/0006 takes the definitions of accessory and component from the Second Schedule of the Medical Device Regulations 2012 and adds one for spare parts. Its Annex A summarises the differences:

Accessories are classified separately

An article counts as an accessory if its labelling, promotional material or other documents clearly show it is intended for use with a specific medical device. MDA/GD/0006 says it should be classified as a medical device in its own right, on its own intended use and risk and independently of the parent device, so it can end up in a different class. It may need separate registration, labelling, traceability and quality system compliance. MDA/GD/0009, the classification rules, says the same: accessories are classified separately from the device they are used with. Accessories supplied with a device can be listed in the device’s registration, as MDA’s electrosurgical unit example shows below. How to fit them into one application is covered on our grouping page.

Components travel with the device

A component is any mechanical, electrical, electronic or software element integrated during manufacture that directly affects the device’s safety, performance or intended function. It is not a medical device; MDA expects it to be controlled through the manufacturer’s quality management system and the device’s conformity assessment. The definition applies only at the pre-market stage. It does not cover parts used later for servicing, maintenance or repair.

Spare parts are outside Act 737 approval

A spare part replaces an identical or functionally equivalent part after the device is on the market, to restore or maintain its original safety, performance and intended use without changing its intended purpose or design. MDA/GD/0006 states that spare parts are not classified as medical devices, are not regulated as medical devices, and do not require approval under Act 737 for importation, exportation or placement in the market. Three conditions come with that:

• the part replaces a faulty, worn or expired part without enhancing or extending the device’s original purpose;
• it maintains the device’s original specifications; and
• it does not affect the device’s regulatory classification or the approval MDA granted.

A “spare part” that upgrades performance or changes the design falls outside the definition, so the exclusion no longer applies; check it against MDA’s change notification rules for the registered device. Fitting the part is still maintenance: section 43 of Act 737 and paragraph 28 of GDPMD apply to whoever maintains the device (see testing, commissioning and maintenance).

Batteries and chargers

MDA’s notes to Annex A deal with a common case. Rechargeable batteries and a charger packed and distributed with the device are usually components, because the device needs them and they are part of the configuration approved at registration. The same batteries or charger supplied later as replacements are generally spare parts, provided they are identical to the approved components and do not affect safety or performance.

MDA’s worked examples (Annex B)

What each answer means for you

• It is a medical device: classify it (Class A to D), register it before it is imported, exported or placed on the market (Act 737 s.5), and hold an establishment licence to deal in it (s.15). Foreign manufacturers need a local authorised representative. Start with how to register.
• It is an accessory: it is a device too. Classify it on its own; register it with the parent device or separately.
• It is a component: no separate registration. It belongs in the device’s CSDT and the manufacturer’s quality system.
• It is a spare part: MDA/GD/0006 says no Act 737 approval is needed to import, export or supply it. Keep evidence that it is identical or functionally equivalent to the approved part.
• It is not a medical device: Act 737 does not apply, but the product may fall under NPRA (medicines and cosmetics) or another regulator.

Getting a ruling from MDA

If the answer is not clear, MDA will decide. Since 1 August 2026 applications go through MDA’s online Product Classification Application System. On MDA’s published terms the fee is RM300 per application, and letters issued from 1 October 2026 are valid for 5 years (MDA announcement of 30 September 2026). The letter decides whether the product is a medical device; it does not give the risk class or rule. Details are on our classification page. For drug–device questions, MDA and NPRA use the MDDCI table and the combination product guideline instead.

Points the guidance is specific about

• The legal definition is in Act 737; MDA/GD/0006 explains it. Where the guidance and the law differ, the law prevails, as every MDA guidance document says.
• An accessory’s class follows its own intended use. A probe or cable can be a different class from the monitor it plugs into.
• The component definition covers only the pre-market stage. A part that was a component at registration can become a spare part when it is later sold as a replacement.
• The spare-part exclusion is conditional. It holds only while the part keeps the original specifications and leaves the device’s classification and approval untouched.