IN exercise of the powers conferred by section 26 of the Medical Device Act 2012 [Act 737], the Minister makes the following order:
1. Citation and commencement · Citation and commencement
(1) This order may be cited as the Medical Device (Designated Medical Device) Order 2026. (2) This Order comes into operation on 1 June 2026.
2. Designated medical device · Designated medical device
The Minister specifies medical devices in column 2 of the Schedule to be a designated medical device which shall be used for the purposes referred to in column 3.
SCHEDULE — SCHEDULE
(1) No. (2) Designated medical device (3) Purpose of use 1. Medical laser (a) Alexandrite laser (756nm) (i) remove hair (ii) remove or reduce pigmentation such as melasma, freckles, etc. (iii) treat vascular lesions such as telangiectasia, spider veins, broken capillaries and rosacea (iv) rejuvenate skin by reducing wrinkles and sagging skin through (1) No. (2) Designated medical device (3) Purpose of use stimulation of collagen production (v) any other aesthetic purpose of use as determined by the manufacturer and in accordance with its intended use (b) Diode laser (800nm) (i) remove hair (ii) rejuvenate skin by reducing wrinkles and sagging skin through stimulation of collagen production (iii) treat acne and reduce skin inflammation (iv) remove or reduce pigmentation such as melasma, freckles, etc. (v) treat vascular lesions such as telangiectasia, spider veins, broken capillaries and rosacea (vi) reduce scar or uneven skin by promoting collagen production and remodelling the scar tissue (vii) any other aesthetic purpose of use as determined by the manufacturer and in accordance with its intended use (c) Erbium YAG laser (2940nm) (i) smoothens the skin (1) No. (2) Designated medical device (3) Purpose of use (ii) remove or reduce scars and uneven skin (iii) rejuvenate skin by reducing wrinkles and sagging skin through stimulation of collagen production (iv) remove or reduce pigmentation such as melasma, freckles, etc. (v) treat actinic keratosis, which is a precancerous skin lesion (vi) remove warts by tissue ablation (vii) any other aesthetic purpose of use as determined by the manufacturer and in accordance with its intended use (d) Fractional CO laser (10,600nm) (i) remove or reduce scars and uneven skin (ii) remove warts by tissues ablation (iii) remove or reduce pigmentation such as melasma, freckles, etc. (iv) treat actinic keratosis, which is a precancerous skin lesion (v) any other aesthetic purpose of use as determined by the manufacturer and in (1) No. (2) Designated medical device (3) Purpose of use accordance with its intended use (e) Nd: YAG laser (532nm or 1064nm) (i) rejuvenate skin by reducing wrinkles and sagging skin through stimulation of collagen production (ii) remove or reduce scars and uneven skin (iii) remove or reduce pigmentation disorders such as melasma, freckles, etc. (iv) treats vascular lesions such as telangiectasia, cherry angioma, etc. (v) remove hair (vi) any other aesthetic purpose of use as determined by the manufacturer and in accordance with its intended use (f) Pulse-dye laser (585nm or 595nm) (i) treat vascular lesions such as spider veins, birthmarks, rosacea and haemangioma (ii) remove or reduce scars and uneven skin (iii) treat pigmented lesions and reduce the appearance of age spots and melasma (1) No. (2) Designated medical device (3) Purpose of use (iv) rejuvenate skin by reducing wrinkles and sagging skin through stimulation of collagen production (vi) any other aesthetic purpose of use as determined by the manufacturer and in accordance with its intended use (g) Ruby laser (694nm) (i) remove or reduce pigmentation such as melasma, freckles, etc. (ii) remove hair (iii) treat vascular lesions such telangiectasia, spider veins, broken capillaries and rosacea (vii) any other aesthetic purpose of use as determined by the manufacturer and in accordance with its intended use 2. HIFU (High-Intensity Focused Ultrasound) device (i) rejuvenate skin by reducing wrinkles and sagging skin through stimulation of collagen production (ii) fat reduction via adipocytes apoptosis or coagulative necrosis (iii) remove or reduce pigmentation such as melasma, freckles, etc. (1) No. (2) Designated medical device (3) Purpose of use (viii) any other aesthetic purpose of use as determined by the manufacturer and in accordance with its intended use 3. Liposuction device (i) remove localised adipose deposits (ii) any other aesthetic purpose of use as determined by the manufacturer and in accordance with its intended use Notes: “nm” in the context of lasers refers to nanometres, which is a unit of wavelength measurement Made 8 January 2026 [KKMMDA(S)100/1-1-1; PN(PU2)711/V] DATUK SERI DR. HAJI DZULKEFLY BIN AHMAD Minister of Health