On 1 June 2026, Malaysia’s Medical Device (Designated Medical Device) Order 2026 (official reference P.U.(A) 10) came into force. Made under Section 26 of the Medical Device Act 2012 (Act 737), this subsidiary legislation brings a group of aesthetic/liposuction devices previously outside strict regulation – including medical lasers of specific wavelengths, HIFU (High-Intensity Focused Ultrasound) devices and liposuction systems – formally under the regulatory framework of Malaysia’s Medical Device Authority (MDA).
1. How the Regulation Came About: “Quiet Legislation”
The mechanism is actually very simple: Section 26 of the Medical Device Act 2012 empowers the Minister, after assessing a type of device’s risk level and public exposure, to declare it a “designated medical device” directly by notice in the Gazette – no parliamentary debate and no press conference, just a notice in the Federal Government Gazette with an effective date.
Timeline: the Order was gazetted on 12 January 2026 and came fully into force on 1 June 2026. The original notice is available on the MDA’s official portal.
2. Which Devices Are Now Regulated
Notably, the Schedule defines regulated medical lasers by “wavelength” rather than brand or trade name. Wavelength determines how deep the energy penetrates and which tissue absorbs it, and therefore what the device can treat and what it can damage. By defining the regulatory boundary with physical parameters rather than marketing names, the regulation closes the loophole of “changing the trade name to avoid regulation”.
Medical lasers in the Schedule include: ruby laser (694 nm), alexandrite laser (755 nm), diode laser (800 nm), Nd:YAG laser (532 nm and 1064 nm), erbium laser (2940 nm), fractional CO2 laser (10,600 nm) and pulsed dye laser (585 nm and 595 nm), corresponding to pigment treatment, hair removal, vascular lesions, scar improvement, tissue ablation, skin resurfacing and treatment of actinic keratosis.
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Medical lasers: precisely defined by wavelength, for hair removal, pigment treatment, vascular lesions, scar improvement, tissue ablation, skin resurfacing, etc.
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HIFU devices: regulated because their energy penetrates deep into tissue and acts at a physiological level, for skin tightening (by stimulating collagen) and fat reduction (by fat-cell apoptosis or coagulative necrosis)
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Liposuction devices: regulated as physical procedure devices with their own risks
Notably, the Order keeps a “flexibility clause” for each type of device: besides the officially listed uses, a device may also be registered for other aesthetic uses as long as the manufacturer can validate and substantiate its intended use claims, leaving companies some room for product positioning.
3. Devices Outside the Scope of This Order
The Order does not cover all aesthetic devices. Two common types are currently outside the Schedule: Intense Pulsed Light (IPL, broad-spectrum light rather than single-wavelength laser) and radiofrequency devices (which heat tissue with electrical energy rather than light or focused ultrasound). It must be stressed that “not in this Schedule” does not mean “not regulated” – all medical devices in Malaysia must still be registered under the same Medical Device Act; IPL and RF devices simply are not currently subject to the new requirement for a designated medical device permit.
4. The Core Change: Device Registration ≠ Permit to Operate
The most easily overlooked but most impactful point of the Order is that it distinguishes between “device registration” and “permission to operate” – both are required.
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Device level: manufacturers/importers must still complete MDA product registration under the Medical Device Act, as before
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Operator level (new): under Section 27 of the Medical Device Act 2012, no one may operate a designated medical device without a Designated Medical Device Permit issued under the law; the permit framework requires operators to be qualified and recognized as competent by the authority
In other words, from 1 June 2026, whether a premises can lawfully provide laser/HIFU/liposuction treatments depends not on whether it calls itself a “clinic” or a “beauty salon”, but on whether the people actually operating the devices hold the legally required permit.
5. Consequences of Non-Compliance
Under Section 27 of the Medical Device Act 2012, operating a designated medical device without the relevant permit is an offence; on conviction, the penalty is a fine of up to RM 200,000, imprisonment of up to 3 years, or both.
6. Practical Impact on Companies and Recommendations
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Aesthetic device manufacturers/importers: if your products are lasers of the listed wavelengths, HIFU or liposuction devices, confirm that their registration status meets the latest MDA requirements and that the intended use in the IFU is consistent with the Schedule and your own validation data
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Distributors and end users (clinics/beauty salons): re-check the registration status of existing devices and whether operators have or can obtain a designated medical device permit – the core enforcement focus of the Order
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Additional uses under the “flexibility clause”: if you plan to register aesthetic uses beyond the official list, prepare validation data supporting those uses in advance for MDA review at registration
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Companies whose products use IPL or RF technology and are currently outside the Schedule: this does not mean exemption from regulation – registration through the normal medical device route is still required, and we recommend watching whether such devices are added in future revisions of the Schedule
Note: this Order is another sign of Malaysia’s tightening regulation of aesthetic devices in recent years, in line with earlier developments such as Malaysia
bringing products such as EndoVista under medical device regulation and the Malaysia–Thailand regulatory reliance being extended to Class B, C and D devices, reflecting that the MDA’s regulatory approach to products at the intersection of aesthetics and medicine continues to tighten and become more detailed. We recommend that companies start compliance self-checks early to avoid being caught out after the new rules took full effect on 1 June.
If you need to check whether specific products (especially lasers of particular wavelengths, HIFU or liposuction devices) fall within the scope of this regulation, assess registration routes, or understand the compliance requirements for operating permits, contact us – the EVERBIZ team will provide professional advice based on your products.