The Medical Device (Designated Medical Device) Order 2026 comes into operation on 1 June 2026. The Minister of Health made the Order on 8 January 2026 under section 26 of the Medical Device Act 2012 (Act 737). The Schedule names specified medical lasers, a HIFU (High-Intensity Focused Ultrasound) device, and a liposuction device for listed aesthetic purposes of use.
What the Order is
The Order is a Federal Government Gazette text. The Attorney General’s Chambers publishes that gazette. The English citation is the Medical Device (Designated Medical Device) Order 2026. The Malay citation on the same gazette is Perintah Peranti Perubatan (Peranti Perubatan yang Ditetapkan) 2026.
The opening of the Order states that, in exercise of the powers conferred by section 26 of the Medical Device Act 2012 [Act 737], the Minister makes the Order. The Minister named at the end of the Order is Datuk Seri Dr. Haji Dzulkefly bin Ahmad, Minister of Health. The Order records that it was made on 8 January 2026. Clause 1 states that the Order may be cited as the Medical Device (Designated Medical Device) Order 2026 and that it comes into operation on 1 June 2026. The made date and the operation date are different dates in the same instrument.
The gazette heading on the Order is 12 January 2026 and P.U. (A) 10. The Medical Device Authority (MDA) lists the same instrument on its legislations page as MEDICAL DEVICE (DESIGNATED MEDICAL DEVICE) ORDER 2026, reference P.U. (A) 10, gazette date 12/01/2026. That page also lists the Medical Device Act 2012 as Act 737. The page names the Medical Device Authority (MDA), Ministry of Health Malaysia.
Clause 2 of the Order states that 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. This article reports that wording. It does not tell a reader which device to use.
The Schedule is numbered. Item 1 is medical laser. Item 2 is the HIFU (High-Intensity Focused Ultrasound) device. Item 3 is the liposuction device.
Designated medical lasers
Item 1 of the Schedule is medical laser. The named lasers and wavelengths are:
- Alexandrite laser (756nm)
- Diode laser (800nm)
- Erbium YAG laser (2940nm)
- Fractional CO2 laser (10,600nm)
- Nd: YAG laser (532nm or 1064nm)
- Pulse-dye laser (585nm or 595nm)
- Ruby laser (694nm)
A note in the Order states that “nm” in the context of lasers refers to nanometres, which is a unit of wavelength measurement.
The listed aesthetic purposes of use in the Schedule include hair removal, pigmentation, vascular lesions, skin rejuvenation, and scars. Pigmentation examples named in the Schedule include melasma and freckles. Vascular-lesion examples named in the Schedule include telangiectasia, spider veins, broken capillaries, and rosacea. Skin rejuvenation is listed as rejuvenate skin by reducing wrinkles and sagging skin through stimulation of collagen production. Scars are listed as remove or reduce scars and uneven skin. For the named lasers the Schedule also includes any other aesthetic purpose of use as determined by the manufacturer and in accordance with its intended use.
This page does not map each laser to a single purpose. It records the names, wavelengths, and purpose headings that the Schedule lists.
Readers who are looking at aesthetic services in this directory can browse the aesthetic clinics category. Pigmentation and related skin services also sit in the dermatology category. Those category pages are a directory grouping, not an MDA list and not a ranking.
HIFU device
Item 2 of the Schedule is the HIFU (High-Intensity Focused Ultrasound) device.
The Schedule lists these purposes of use for that device:
- rejuvenate skin by reducing wrinkles and sagging skin through stimulation of collagen production
- fat reduction via adipocytes apoptosis or coagulative necrosis
- remove or reduce pigmentation such as melasma, freckles, etc.
- any other aesthetic purpose of use as determined by the manufacturer and in accordance with its intended use
Those phrases are the Schedule’s purpose-of-use wording. This article does not interpret them as a clinical recommendation.
Liposuction device
Item 3 of the Schedule is the liposuction device.
The Schedule lists these purposes of use:
- remove localised adipose deposits
- any other aesthetic purpose of use as determined by the manufacturer and in accordance with its intended use
That is the purpose list for the liposuction device in the English Schedule text used here. This directory also groups surgical aesthetic listings under plastic and aesthetic surgery. That is a site category, not a designation in the Order.
Electronic establishment licences from 16 April 2026
A separate MDA announcement records a change to establishment licences. The Medical Device Authority (MDA) will fully implement the use of electronic establishment licenses effective 16 April 2026. The announcement is signed Medical Device Authority, Malaysia Ministry of Health.
The announcement states that establishments may download their establishment license from the MeDC@St 2.0+ system once the application is completed (status: complete) and the license fee has been fully paid, where applicable.
For applications approved before 16 April 2026, establishments will receive a physical establishment license in accordance with the existing process. At the same time, the electronic establishment license may also be downloaded from the MeDC@St 2.0+ system. The announcement states that establishments are required to collect the physical license at the MDA office after seven (7) working days from the application completion date (status: complete).
For applications approved after 15 April 2026, only the electronic establishment license will be issued by the MDA.
That announcement is about MDA establishment licences and the MeDC@St 2.0+ system. It is not the 1 June 2026 commencement of the designated-device Order. The two public texts sit next to each other as MDA records: one names designated devices and listed purposes of use, and the other records how establishment licences are issued. This article reports the announcement’s wording about establishments. It does not say that a reader must hold an establishment licence.
What a reader can check
The public record for the designated devices is the Order itself, including the Schedule. The MDA legislations page lists that Order as P.U. (A) 10. The public record for the 16 April 2026 licence format is the MDA announcement on electronic establishment licenses.
A reader who is checking a rule can read those two MDA texts. The named authorities in those texts are the Medical Device Authority (MDA), the Ministry of Health Malaysia (MOH / KKM), and the Medical Device Act 2012 (Act 737). This directory does not replace those records.
HealthAesthetics MY is independent of the Medical Device Authority and the Ministry of Health Malaysia. This page does not rank clinics and does not name a business price.
This article is for information only and does not constitute medical advice. Always consult a licensed healthcare provider before undergoing any treatment.
Sources
- Medical Device Authority / Attorney General’s Chambers. Medical Device (Designated Medical Device) Order 2026
- Medical Device Authority. Announcement: full implementation of electronic establishment licenses effective 16 April 2026
- Medical Device Authority. List of Legislations (P.U. (A) 10, gazette date 12/01/2026)