Physiotherapy and rehabilitation equipment in Malaysia: what MDA regulates, and in which class.

Device or not comes from GD/0061. The class comes from the rules.

MDA’s guidance document MDA/GD/0061, Classification of Rehabilitation, Physiotherapy and Speech Therapy Device (Second Edition, dated 9 March 2023 on MDA’s list and 8 March 2023 on its cover), answers one question: whether a product used in rehabilitation, physiotherapy or speech therapy is a medical device, based on the intended purpose the manufacturer claims. Its Annex A is normative and lists the products MDA classifies as medical devices. Annex B shows pictures of some of them.

• GD/0061 gives no risk class or rule. The class comes from the First Schedule to the Medical Device Regulations 2012, which MDA explains in MDA/GD/0009.
• Almost everything in Annex A is Class A. Bands, boards, bars, putty, hand exercisers, walkers, positioning seats, goniometers and speech therapy kits are non-invasive and not powered, so Rule 4 makes them Class A. Class A is registered directly with MDA, with no conformity assessment body (CAB), but it is still registered.
• Energy-delivering physiotherapy equipment is usually Class B. TENS, muscle stimulators and therapeutic ultrasound fall under Rule 9(i), and the ASEAN list (MDA/GD/0062) adds shortwave and ultrasonic diathermy, shockwave therapy and infrared heating lamps. Rule 9(i) moves a device to Class C if it delivers energy in a potentially hazardous way. These go through a CAB first.
• Claims decide. GD/0061 itself says exercise mats for general exercise, positioning wedges used only for positioning, and weights for general wellness are not medical devices. A treadmill sold for fitness is not a device; one sold for cardiac therapy is.

Placing an unregistered medical device on the market is an offence under section 5 of the Medical Device Act 2012 (Act 737), with a fine of up to RM200,000, up to three years’ imprisonment, or both. Class A has a lighter route, not an exemption.

What GD/0061 covers

GD/0061 is aimed at manufacturers and authorised representatives. It takes its definitions from the Act and from MS 2752 (Prosthetic and orthotic devices – Code of practice): rehabilitation is a set of interventions designed to optimise functioning and reduce disability, and physiotherapy is services that develop, maintain and restore maximum movement and functional ability. The intended purpose is the manufacturer’s objective intent as reflected in its specifications, instructions and information. That last definition does the work: the same wobble board is a medical device when it is supplied for rehabilitation and an ordinary product when it is sold for a home gym.

The products MDA lists as medical devices.

The headings and products below are GD/0061’s, in its order. The class column is our application of the First Schedule rules, not part of GD/0061. Each of these products is non-invasive and, unless marked as powered, has no power source, so Rule 4 (“all other non-invasive medical devices are in Class A”) applies.

Annex A is MDA’s list of what counts as a medical device. Rules 1 to 3 do not reach these products, because none of them touches injured skin, channels or stores liquids, gases or tissues for the body, or modifies the composition of blood or other body liquids, which leaves Rule 4. A product that is supplied sterile, used on broken skin or combined with a powered unit needs its own check. The full method is in our classification guide.

Powered rehabilitation equipment: the question that sets the class.

The Medical Device Regulations 2012 define an active medical device as one that depends on electrical energy or another power source other than the human body or gravity, and that acts by converting that energy. Once a rehabilitation product is powered, two rules compete:

• Rule 9(i): active therapeutic devices intended to administer or exchange energy are Class B, and Class C if they may do so in a potentially hazardous way, taking account of the nature, density and site of the energy. GD/0009’s Class B examples include muscle stimulators, TENS devices and ultrasound equipment for physiotherapy.
• Rule 12: all other active devices are Class A. GD/0009’s examples include powered hospital beds and wheelchairs.

Applied to the powered items in GD/0061:

• Motorised parallel-bar platforms, rehabilitation treadmills and powered body trainers. On our reading they move the patient or a platform rather than deliver energy into the body, which puts them with powered beds and wheelchairs under Rule 12, Class A. No MDA document names their class, so the file should set out that reasoning.
• Electric and percussion massagers. They act on tissue with mechanical energy, so the Rule 9(i) question is a real one. MDA publishes no class for them. We would not file a powered massager as Class A without a written rationale for why Rule 9(i) does not apply.
• Heat and cold packs. GD/0009 says pads that only release stored thermal energy are not active devices, while pads that heat or cool by chemical reaction are, because they convert chemical energy into heat. MDA/GD/0063 treats a heat or cooling pad intended to relieve aches and pains as a medical device.

Electrotherapy, mobility and other physiotherapy equipment.

GD/0061 does not cover electrotherapy, mobility aids or orthoses. MDA has classed many of them elsewhere, either as examples under the rules in GD/0009 or in the ASEAN harmonised list it adopted as MDA/GD/0062 (Third Edition, June 2025):

GD/0062 lists only the diathermy versions “for use other than applying therapeutic deep heat”. For a deep-heating unit, the class follows Rule 9(i) and its potentially hazardous test. MDA/GD/0063 also treats cold laser therapy for pain management as a medical device, without giving a class.

When the same product is not a medical device.

GD/0061 and the ASEAN borderline list (MDA/GD/0063, Third Edition, June 2025) turn on the same thing: what the manufacturer claims the product is for. These are MDA’s own decisions on look-alike products:

Sensory products show how narrow the line is. GD/0061 lists sensory stimulation kits and vestibular swing systems used in therapy, including for children with autism, as medical devices, while GD/0063 treats a therapressure brush with calming and body-awareness claims as not a device. Where a product sits between the two, MDA’s product classification application gives a written answer: RM300 per application for up to 10 products sharing one name, intended use and manufacturer, with a letter valid for 5 years if issued from 1 October 2026. The letter says whether the product is a medical device. It does not give the class.

The decision also runs the other way. A fitness brand that starts describing its equipment as being for rehabilitation, stroke recovery or joint pain is making medical-device claims, and the product then needs registration before it is sold with them. For the outer edge of the definition, see what counts as a medical device.

Registering a rehabilitation range.

1. Sort the catalogue by intended purpose first. Take each product’s label, IFU and marketing copy and decide whether it is sold for rehabilitation, therapy or diagnosis, or for fitness and wellness. Only the first group needs a class.
2. Then classify. Non-powered, non-invasive items are Class A under Rule 4. For every powered item, record whether it delivers energy to the body (Rule 9(i)) or not (Rule 12).
3. Group to control the fees. Since 1 January 2026 every Class A application carries RM1,250 in MDA fees (P.U. (A) 330/2025), so a range filed one product at a time gets expensive. A family must share one class, name, intended purpose, design and manufacturing process, and may differ only in the permissible variants of MDA/GD/0005 Annex C. A colour-coded band range differs in resistance as well as colour, so check that difference against the list before treating it as one family. A hand therapy kit sold under one set name takes the class of its highest-class item. See our grouping guide.
4. Apply through the right licence holder. The applicant must be a licensed local manufacturer or authorised representative. Class A goes straight to MDA through MeDC@St. Class B–D items need a CSDT reviewed by a registered CAB first.
5. License the supply chain. Importers and distributors need an establishment licence and GDPMD. A retailer that buys from a licensed distributor does not, but the device must still be registered; see selling devices online.

Related rules that catch rehabilitation suppliers

• Advertising to the public needs MDA approval for registered devices, and unregistered devices may not be advertised at all. See advertisement approval.
• Personal-use imports are capped. MDA’s quantity table allows one unit of a physiotherapy device for an individual’s own use, not for professional or clinical use. See personal-use import.
• Used equipment from a closing clinic or overseas is a refurbishment question, not a free resale. See refurbished devices.
• Public demand. Budget 2027 expands MOH outsourcing to rehabilitation and turns 15 community rehabilitation (PDK) premises into specialised therapy centres. See Budget 2027.

What registration costs with us.

All-in: our professional work, CAB fees for Class B–C and MDA statutory fees. Do not add the statutory table above to these figures. Grouped catalogue registrations are quoted per registration once we have seen the range, and how many registrations a package covers depends on MDA’s grouping rules. Full schedule on pricing.

Our reading

• Class A is not the hard part. Intended purpose is. Most rehabilitation catalogues are Class A once the claims are settled. The time goes into deciding which products are sold for therapy and making labels, IFUs and listings say the same thing.
• Do not let one powered item set the pace. File the Rule 4 range directly with MDA and settle the Rule 9(i) questions on powered massagers or stimulators separately, so the Class A products are not held up.
• Keep fitness and therapy lines apart. If the same treadmill or massager is sold as both, use separate model names and separate marketing. A fitness listing that borrows rehabilitation claims turns the fitness model into an unregistered medical device.