Malaysia, 31 Jan 2026 — The Medical Device (Designated Medical Device) Order 2026 has now formally been published in the Federal Government Gazette. This new Order explicitly designates specific aesthetic equipment including various lasers, HIFU, and liposuction devices as regulated medical devices under the Medical Device Act 2012. For manufacturers of aesthetic equipment, this regulation provides a definitive “green list” of approved devices and their intended uses. The Medical Device Authority will oversee the enforcement of these new regulations, ensuring that manufacturers comply with safety and performance standards.
FEDERAL GOVERNMENT GAZETTE: TIMELINE FOR MANUFACTURERS
- 12 January 2026: The Order was officially published in the Federal Government Gazette.
- 1 June 2026: The Order comes into full operation. By this date, all devices falling under these designations must comply with the Medical Device Act 2012.
AESTHETIC EQUIPMENT DESIGNATED DEVICES & INTENDED USES
The Order specifies three primary categories of devices that are now legally designated as medical devices. The Schedule to the Order provides precise technical specifications (wavelengths) and approved purposes. This includes aesthetic equipment used in various medical and cosmetic treatments, now regulated under the Medical Device Authority.
Medical Lasers
The Order breaks down lasers by specific wavelengths. If your device matches these specifications, it is a designated medical device under the Federal Government Gazette.
- Alexandrite Laser (756nm): Hair removal, pigmentation reduction (e.g., melasma), vascular lesion treatment, and skin rejuvenation via collagen stimulation.
- Diode Laser (800nm): Hair removal, skin rejuvenation, acne treatment, pigmentation reduction, vascular lesion treatment, and scar reduction.
- Erbium YAG Laser (2940nm): Skin smoothing, scar reduction, skin rejuvenation, pigmentation reduction, treatment of actinic keratosis (precancerous lesions), and wart removal.
- Fractional CO2 Laser (10,600nm): Scar reduction, wart removal, pigmentation reduction, and actinic keratosis treatment.
- Nd: YAG Laser (532nm or 1064nm): Skin rejuvenation, scar reduction, pigmentation disorders, vascular lesions (e.g., cherry angioma), and hair removal.
- Pulse-dye Laser (585nm or 595nm): Vascular lesions (spider veins, birthmarks, rosacea, haemangioma), scar reduction, and pigmented lesions.
- Ruby Laser (694nm): Pigmentation reduction, hair removal, and vascular lesion treatment.
HIFU (High-Intensity Focused Ultrasound) Devices
HIFU devices are designated for the following specific uses:
- Rejuvenation: Reducing wrinkles and sagging skin through collagen stimulation.
- Fat Reduction: Via adipocytes apoptosis or coagulative necrosis.
- Pigmentation: Removing or reducing melasma, freckles, etc.
Liposuction Devices
Primary Use: Removal of localized adipose (fat) deposits.
WHAT MANUFACTURERS NEED TO KNOW
The “Manufacturer’s Determination” Clause
Crucially, for every device category listed above, the Order includes a flexibility clause. In addition to the specific government-listed uses, the device may be used for:
- Any other aesthetic purpose of use as determined by the manufacturer and in accordance with its intended use.
- This allows manufacturers to validate and register devices for additional aesthetic indications beyond those explicitly listed in the Schedule, provided they are supported by the manufacturer’s technical documentation. These provisions apply to various aesthetic equipment now regulated under the Federal Government Gazette.
Impact on Registration
- Mandatory Compliance: As of 1 June 2026, any device falling within these definitions is a “Designated Medical Device.” Manufacturers must ensure these devices are registered with the Medical Device Authority (MDA).
- Technical Specifications: Note the specific wavelengths (e.g., “800nm” for Diode). Manufacturers should verify their device specifications align exactly with the “Column 2” descriptions in the Schedule, in compliance with the Ministry of Health Malaysia guidelines for aesthetic supplies.