A distributor or private-label buyer quoting a 1470 nm endovenous laser source, a sterile single-use fiber, or both into Malaysia will be shown P.U. (A) 10 and told that diode lasers now require a new clearance. The order is real. It was made by the Minister of Health on 8 January 2026 under section 26 of the Medical Device Act 2012, published in the Federal Government Gazette as P.U. (A) 10 on 12 January 2026, and brought into operation on 1 June 2026.13 The decision on this shipment is narrower than that summary: does column 2 name the object being quoted?
This page reads the schedule against a 1470 nm source, a 980 nm plus 1470 nm source, and a passive fiber. It is a designation test and a statutory split. It is not an MDA registration manual, a conformity-assessment fee card, or a procedure for treating veins.
Which wavelengths does the 1 June 2026 order actually name?
Clause 1(2) says the order comes into operation on 1 June 2026. Clause 2 says: 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. The citation line is section 26 of Act 737. A note in the schedule says that, for lasers, nm means nanometres.1
Item 1 is headed Medical laser. Each lettered row prints one device name and a wavelength. The English column 2 labels read on 3 October 2026 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), and Ruby laser (694nm). Item 2 is an HIFU device. Item 3 is a liposuction device. The figure 1470 does not appear. The figure 980 does not appear.1
| Row | Column 2 device, as printed | Column 3 purposes, English text | 1470 nm or 980 nm named here? |
|---|---|---|---|
| 1(a) | Alexandrite laser (756nm) | Remove hair. Remove or reduce pigmentation such as melasma, freckles, etc. Treat vascular lesions such as telangiectasia, spider veins, broken capillaries and rosacea. Rejuvenate skin by reducing wrinkles and sagging skin through stimulation of collagen production. Any other aesthetic purpose of use as determined by the manufacturer and in accordance with its intended use. | No. The order prints 756 nm. The conventional catalogue figure is often 755 nm. Keep the gazetted figure. |
| 1(b) | Diode laser (800nm) | Remove hair. Rejuvenate skin by reducing wrinkles and sagging skin through stimulation of collagen production. Treat acne and reduce skin inflammation. Remove or reduce pigmentation such as melasma, freckles, etc. Treat vascular lesions such as telangiectasia, spider veins, broken capillaries and rosacea. Reduce scar or uneven skin by promoting collagen production and remodelling the scar tissue. Any other aesthetic purpose of use as determined by the manufacturer and in accordance with its intended use. | No. This is the only diode row, and it prints 800 nm. |
| 1(c) | Erbium YAG laser (2940nm) | Smoothens the skin. Remove or reduce scars and uneven skin. Rejuvenate skin by reducing wrinkles and sagging skin through stimulation of collagen production. Remove or reduce pigmentation such as melasma, freckles, etc. Treat actinic keratosis, which is a precancerous skin lesion. Remove warts by tissue ablation. Any other aesthetic purpose of use as determined by the manufacturer and in accordance with its intended use. | No. |
| 1(d) | Fractional CO2 laser (10,600nm) | Remove or reduce scars and uneven skin. Remove warts by tissues ablation, as the English line reads. Remove or reduce pigmentation such as melasma, freckles, etc. Treat actinic keratosis, which is a precancerous skin lesion. Any other aesthetic purpose of use as determined by the manufacturer and in accordance with its intended use. | No. |
| 1(e) | Nd:YAG laser (532nm or 1064nm) | Rejuvenate skin by reducing wrinkles and sagging skin through stimulation of collagen production. Remove or reduce scars and uneven skin. Remove or reduce pigmentation disorders such as melasma, freckles, etc. Treats vascular lesions such as telangiectasia, cherry angioma, etc. Remove hair. Any other aesthetic purpose of use as determined by the manufacturer and in accordance with its intended use. | No. The printed wavelengths are 532 nm or 1064 nm. This vascular phrase names telangiectasia and cherry angioma. It does not use the words spider veins. |
| 1(f) | Pulse-dye laser (585nm or 595nm) | Treat vascular lesions such as spider veins, birthmarks, rosacea and haemangioma. Remove or reduce scars and uneven skin. Treat pigmented lesions and reduce the appearance of age spots and melasma. Rejuvenate skin by reducing wrinkles and sagging skin through stimulation of collagen production. Any other aesthetic purpose of use as determined by the manufacturer and in accordance with its intended use. The English and Malay columns print (i), (ii), (iii), (iv), and (vi). No (v) is visible. | No. |
| 1(g) | Ruby laser (694nm) | Remove or reduce pigmentation such as melasma, freckles, etc. Remove hair. Treat vascular lesions such as telangiectasia, spider veins, broken capillaries and rosacea. The English conversion reads "such telangiectasia" without "as". Any other aesthetic purpose of use as determined by the manufacturer and in accordance with its intended use. | No. |
| 2 | HIFU (High-Intensity Focused Ultrasound) 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. | No. This row is not a laser. |
| 3 | Liposuction device | Remove localised adipose deposits. Any other aesthetic purpose of use as determined by the manufacturer and in accordance with its intended use. | No. This row is not a laser. |
Three numeral points should stay visible, because the MDA-hosted PDF conversion does not number every row the same way in English and Malay. For the pulse-dye row, both languages show (i), (ii), (iii), (iv), and (vi), and neither shows a (v). For the ruby row, the Malay catch-all is numbered (iv) and the English catch-all is numbered (vii). For HIFU, the Malay catch-all is numbered (iv) and the English catch-all is numbered (viii). The purpose sentences above are the sentences that are legible. A missing numeral is not a hidden purpose, and this page does not invent one.1
The alexandrite rejuvenation sentence breaks across a page in the English column. The Malay column keeps that sentence, including collagen stimulation, as one purpose, and puts the aesthetic catch-all on the next number. The table follows that purpose text. Alexandrite is printed as 756 nm in both languages. A clinic note records the same printed figure and the conventional 755 nm catalogue figure. The gazette figure is the one to quote.15
Intense pulsed light and radiofrequency consoles are not column 2 labels in the text that was read. A pneumatic injector is not a column 2 label. A passive fiber is not a column 2 label. Those absences are readings of this schedule. They are not a statement that every unnamed object is outside Act 737.
Is an 800 nm diode the same row as a 1470 nm vein laser?
The public fiber page states wavelength 1470 nm. The public NOVACURE page states two partner-supplied configurations: NOVACURE 1470 nm, and NOVACURE-Dual 980 nm plus 1470 nm.67 Both are semiconductor diode sources in ordinary product language. Item 1(b) still prints Diode laser (800nm). A shared diode architecture does not move 980 nm or 1470 nm onto that line. The schedule already shows that it names wavelengths when it means to: Nd:YAG is printed as 532 nm or 1064 nm, and the pulse-dye row is printed as 585 nm or 595 nm.1
The words spider veins are not a single diode-only phrase. They appear in column 3 for alexandrite, the 800 nm diode, the pulse-dye laser, and the ruby laser. On those rows they sit with telangiectasia, broken capillaries, rosacea, birthmarks, or haemangioma, depending on the row. The Nd:YAG row uses a different vascular phrase: telangiectasia, cherry angioma, and so on. None of those rows prints 1470 nm or 980 nm. None prints endovenous ablation, the saphenous vein, or varicose-vein treatment.1
The fiber page and the NOVACURE page describe endovenous workflows for varicose veins at the wavelengths those pages state. That stated use is a different purpose from the cutaneous vascular-lesion phrases in column 3. The catch-all on each row is any other aesthetic purpose of use as determined by the manufacturer and in accordance with its intended use. It sits inside the device named in that row. It does not add a wavelength the row does not print, and it does not rewrite column 2.167
A 28 January 2026 consultancy note lists diode laser (800 nm) with the other named lasers and describes the order as bringing aesthetic devices under MDA oversight as medical devices.4 The wavelength list matches column 2. The legal step is clause 2, which specifies designated medical devices for the column 3 purposes under section 26. Clause 2 is not the registration offence in section 5, and it is not a section 2(b) declaration.12
What does section 27 require, and what does section 5 still require?
Act 737 uses four different mechanisms. They are easy to collapse into one "registration" sentence, and they are not the same sentence.
- Section 2(a) and section 2(b). Section 2(a) defines a medical device by the manufacturer's intended purposes, including diagnosis, treatment, or alleviation of disease, where the primary action is not pharmacological, immunological, or metabolic. Section 2(b) lets the Minister declare an article to be a medical device by gazette order after considering public safety, public health, or public risk. The legislation list records a separate 2017 instrument for that declaration power: P.U. (A) 339, the Medical Device (Declaration) Order 2017. This page did not re-read the 2017 schedule, so it does not say what that order declared.23
- Section 5(1) and section 6. Section 5(1) says no medical device shall be imported, exported, or placed in the market unless it is registered under the Act. Section 6 says an application for registration is made by an establishment to the Authority. The definition of place in the market excludes making a device available for clinical research or for performance evaluation. The import limb of section 5(1) does not repeat that exclusion.2
- Section 3. A medical device is classified by an establishment, based on risk, intended use, and the vulnerability of the human body, in the prescribed manner. A dispute with a conformity assessment body goes to the Authority. P.U. (A) 10 does not assign Class A, B, C, or D, and a Chinese Class II or Class III number is not that Malaysian classification.2
- Section 15(1). No establishment shall import, export, or place in the market any registered medical device unless it holds an establishment licence granted under the Act. Section 2 defines an establishment as a manufacturer, importer, or distributor responsible for placing a medical device in the market, and that paragraph does not include a retailer. The same definition includes an authorized representative appointed by a manufacturer whose principal place of business is outside Malaysia. The person or firm must be domiciled or resident in Malaysia, or constituted under Malaysian law, and must carry on business principally in Malaysia. The licence is not a Royal Malaysian Customs entry by itself.2
- Section 26 and section 27(1). Section 26 lets the Minister, after considering risk, exposure to public health, patient safety, and the degree of complexity, specify a medical device as a designated medical device by gazette order. Section 27(1) says no person shall use or operate any designated medical device unless that person holds a designated medical device permit granted under the Act. Section 28 is the application. Section 30 is the Authority's grant or refusal. Section 30 says a granted permit is subject to the prescribed fee and to conditions. This page did not read a fee instrument, so it states no ringgit amount for the permit.2
P.U. (A) 10 is the section 26 order. Its clause 2 specifies the column 2 devices as designated medical devices for the column 3 purposes. The person who uses or operates one of those devices is the person section 27 speaks to. The order does not replace section 5, and it does not say that designation is the act of registration.12
View chart data
| Category | Maximum fine (RM '000) |
|---|---|
| Section 5(2) unregistered import or market placement | 200 |
| Section 15(2) establishment without a licence | 200 |
| Section 27(2) use or operation without a permit | 100 |
- These are statutory maxima in the English file read on 3 October 2026, not typical sentences. Section 5(2) and section 15(2) also allow imprisonment not exceeding three years, or both. Section 27(2) allows imprisonment not exceeding one year, or both.
Section 5(2) applies to a person who contravenes the registration rule: a fine not exceeding two hundred thousand ringgit, imprisonment not exceeding three years, or both. Section 15(2) uses the same maximum for an establishment that imports, exports, or places a registered device in the market without an establishment licence. Section 27(2) is the lower maximum: a fine not exceeding one hundred thousand ringgit, imprisonment not exceeding one year, or both, for using or operating a designated device without the permit. The two higher maxima are not interchangeable with the section 27 maximum.2
If the quoted 1470 nm source or the fiber is a medical device under section 2, section 5 still has to be answered before import, export, or placing in the market. P.U. (A) 10 does not create an exemption from that duty. The legislation list marks the Medical Device (Exemption) Order 2016, P.U. (A) 103, as revoked. The same list, last updated 13 January 2026, shows P.U. (A) 10 as the designated-device order and does not show an amending medical-device order on the page read on 3 October 2026. That index date is a limit. It is not a search of every later federal gazette, and this page did not read a separate exemption as covering a 1470 nm source or a fiber.23
For an object that is not in column 2, section 27 does not attach on the strength of this order. An 800 nm diode that matches item 1(b) and a column 3 purpose is in the other position: section 5 can still apply to the device, and section 27 applies to the person who uses or operates it. A patient-facing clinic note updated 17 August 2026 prints diode as 800 nm and alexandrite as 756 nm, says IPL and radiofrequency are not named, and separates device registration from the section 27 permit. The same note calls both of those checks the new law. Section 5 is the older registration offence. This order did not create it. The note also describes HIFU as listed for tightening. The English schedule's HIFU purposes are the collagen-rejuvenation sentence, fat reduction via adipocytes apoptosis or coagulative necrosis, pigmentation, and the aesthetic catch-all. The same note still mentions devices notified under the 2016 exemption order. The legislation list marks that order, P.U. (A) 103, as revoked.1235
Does the single-use fiber enter the schedule with the console?
Column 2 names lasers, an HIFU device, and a liposuction device. It does not name a fiber, a connector, or a procedure kit. A quotation that bundles a generator and a disposable fiber still has two objects to test. The fiber does not become item 1(b) because it is in the same consignment.1
Public registers often list a fiber, a generator, and a kit on different rows. That identity question is already set out in the guide on how public registers separate an endovenous fiber from a generator. The incoming-file guide states the related document point: an IEC 60601-2-22 file belongs with laser equipment that incorporates the source, and the public fiber page does not publish that particular, an ISO 11135 cycle, or an SMA-905 specification.910
| Object on the quotation | What the public page states | Column 2 of P.U. (A) 10 | Act 737 duty this order does not cancel |
|---|---|---|---|
| 1470 nm endovenous source | NOVACURE 1470 nm is a partner-supplied configuration. The registration holder on the page is Guangdong Yunshang. Weihai Medison is not the manufacturer and is not the holder of Guo Xie Zhu Zhun 20253011190. | Not named. Item 1(b) is an 800 nm diode. | If it is a medical device under section 2, section 5 still covers import, export, and placing in the market. Section 27 does not attach from this schedule. |
| 980 nm plus 1470 nm source | The same page states NOVACURE-Dual 980 nm + 1470 nm as the second configuration. The CE and FDA line is a supplier-table note. | Neither wavelength is printed in column 2. | Same section 5 question. The supplier-table CE and FDA line is not a Malaysian registration. |
| Single-use 1470 nm fiber | The fiber page states Class II, Lu Mech Reg. 20192010517, wavelength 1470 nm, and a partner-supplied source. It is single-use and sterile. It does not publish connector, core, numerical aperture, or a sterilization-cycle edition. | Not named. | Same section 5 question if the fiber is a medical device by intended purpose. Malaysia class is section 3, not the Chinese class on the page. |
| 800 nm diode matching item 1(b) | Not a VEMERIX product page. The test is the order. | Named, for the column 3 purposes printed on that row. | Section 5 can still apply to the device. The person who uses or operates it needs the section 27 permit. |
| Pneumatic injector | The Magic Injector page states Class II, Lu Mech Reg. 20252140023, and pneumatic-controlled microinjection. Models 1, 2, and 3. | Not named. The HIFU and liposuction rows do not describe a pneumatic injector. | This order does not assign it a Malaysian class. Section 5 is a separate intended-purpose question. |
Connector, core diameter, numerical aperture, and introducer size are specification questions. They belong in the 1470 nm radial fiber specification guide, which treats SMA-905, core diameter, and numerical aperture as match points against the console. Those match points are not printed on the fiber page, and they are not rows in P.U. (A) 10.116
The Magic Injector is a negative example only. The page describes a pneumatic microinjection device used with sterile needles in aesthetic workflows. Column 2 of this order does not name it. Nothing in that comparison gives the injector an MDA class, and the sterile needle is not added to the schedule by association.81
What should a Malaysia quote ask before shipment?
The file to request depends on which column the object actually occupies. Asking for a section 27 permit on a 1470 nm source, or filing a page that calls the absence an exemption, answers the wrong instrument.
| Question | Document | Who should hold it | What the check is for |
|---|---|---|---|
| Is this object printed in column 2 at the stated wavelength and purpose? | The quotation, the label, and the instructions, set beside P.U. (A) 10 | The person preparing the Malaysia file | If column 2 does not name it, do not request a section 27 permit for this order, and do not label the file as an exemption. |
| Is it a medical device under section 2? | Intended-purpose statement from the manufacturer | Manufacturer, then the Malaysian establishment | Section 5(1) covers import, export, and placing in the market of a medical device. This order is not an exemption order. A separate exemption, if one is relied on, has to be read on its own text. |
| Is there a registration? | MDA registration for the trade name, manufacturer, and models on the invoice | The establishment that applies under section 6 | Match the certificate to the shipping identity. This page does not republish a register count. |
| Can that establishment import or place the registered device? | Establishment licence under section 15 | The Malaysian manufacturer, importer, distributor, or authorized representative in the section 2 definition. A retailer is outside paragraph (a) of that definition. | The licence covers import, export, or placing a registered device in the market. It is not, by itself, a customs release. |
| Who will use or operate it? | Designated medical device permit, only if column 2 matches | The person who uses or operates the designated device | Application under section 28. Grant or refusal under section 30. No permit fee was read for this page. For a 1470 nm source or a passive fiber, this row stays closed on the text of P.U. (A) 10. |
A Malaysia registration does not place the same device in Singapore. The Singapore guide explains when an existing MDA registration can open an HSA abridged evaluation, and it says that reliance is not a Malaysia market-entry guide. Read that section for the Singapore direction. Do not use it as the column 2 test on this page.12
Where VEMERIX fits—and where due diligence still begins
VEMERIX is the international brand of Weihai Medison Medical Equipment Co., Ltd., positioned as a Minimally Invasive Surgery Total Solution Platform serving urology, vascular surgery and perioperative care. For this order, the useful boundary is which object Medison manufactures and which object is partner-supplied.
- Disposable medical laser fiber. The public fiber page states a single-use sterile fiber, Chinese Class II registration Lu Mech Reg. 20192010517, wavelength 1470 nm, used with a partner-supplied diode laser source.6 That page does not place the fiber on the Malaysian schedule, and it does not publish a connector drawing, a numerical aperture, or a sterilization-cycle edition.
- NOVACURE source. The public NOVACURE page states a partner-supplied diode laser source. The registration holder is Guangdong Yunshang (white-label production), under Guo Xie Zhu Zhun 20253011190. The stated configurations are 1470 nm and 980 nm plus 1470 nm.7 Weihai Medison does not manufacture that console and does not hold that registration. Neither configuration is the order's 800 nm diode row.
The quality page states ISO 9001 and ISO 13485 quality systems and an in-house ethylene-oxide sterilization line at the Weihai plant, and it says certificates can be requested.13 Those are company statements. They are not an MDA registration of the fiber, and they are not a published ISO 11135 cycle for this SKU. A buyer who needs the lot file should ask for the sterilization method and validation that apply to the lot being shipped, and should take connector and numerical-aperture questions to the specification guide rather than treating an industry range as a figure printed for this fiber.1011
Due diligence for a Malaysia file starts with the column 2 test and the section 5 registration held by the Malaysian establishment. It does not start with a section 27 permit that this order does not require for a 1470 nm source or a passive fiber. For the partner-supplied console, the next document is the registration dossier of the holder named on the page, Guangdong Yunshang. Sample, technical-pack, and registration-document requests for the Medison fiber go through the laser fiber page or the contact desk.
Frequently asked questions
Does the order cover every diode laser, including 980 nm and 1470 nm?
The only diode entry is item 1(b), Diode laser (800nm). The schedule read on 3 October 2026 does not print 980 nm or 1470 nm. Other laser rows print their own wavelengths, including 532 nm or 1064 nm and 585 nm or 595 nm, which shows that the order states the wavelength it is using.1
Do the words spider veins in the schedule mean endovenous ablation?
The schedule uses spider veins inside the purpose lists for the alexandrite, 800 nm diode, pulse-dye, and ruby rows, together with telangiectasia, rosacea, birthmarks, haemangioma, or broken capillaries, depending on the row. It does not use those words for a 1470 nm source, and it does not name endovenous ablation or the saphenous vein. The fiber and NOVACURE pages describe varicose-vein workflows at 1470 nm, or at 980 nm plus 1470 nm. That is a different stated purpose from those column 3 phrases.167
If the 1470 nm source is not in the schedule, can it be imported with no MDA registration?
Absence from this schedule means section 27 does not attach on the strength of P.U. (A) 10. If the source is a medical device under section 2, section 5(1) still says it shall not be imported, exported, or placed in the market unless it is registered. The maximum under section 5(2) is a fine not exceeding RM200,000, imprisonment not exceeding three years, or both. This page did not read an exemption order as covering that source.2
Does a pneumatic aesthetic injector fall under the HIFU or laser rows?
Column 2 names specified lasers, an HIFU device, and a liposuction device. The HIFU purposes that were legible are skin rejuvenation through collagen stimulation, fat reduction via adipocytes apoptosis or coagulative necrosis, pigmentation, and the aesthetic catch-all. The liposuction purposes are removal of localised adipose deposits and the aesthetic catch-all. A pneumatic microinjection device is not either description. The Magic Injector page is used here only as that negative example.18
What is the difference between a section 26 designation and a section 2(b) declaration?
Section 2(b) is the power to declare an article to be a medical device by gazette order, after considering public safety, public health, or public risk. Section 26 is the power to specify a medical device as a designated medical device by gazette order, after considering risk, public-health exposure, patient safety, and complexity. P.U. (A) 10 cites section 26. The legislation list keeps P.U. (A) 339 of 2017 as the declaration order. This page did not re-read what P.U. (A) 339 declared.123
Can a clinic or distributor be fined RM200,000 under section 27?
Section 27(2) sets a fine not exceeding RM100,000, imprisonment not exceeding one year, or both, for using or operating a designated medical device without the permit. The fine not exceeding RM200,000, or imprisonment not exceeding three years, or both, is the maximum in section 5(2) for the registration offence and the same maximum in section 15(2) for an establishment that handles a registered device without an establishment licence.2