Microneedling Regulation Outside the US: Canada, Australia, the EU and UK

Canada is the strictest of the four. Selling a microneedling pen or cartridge there needs a Health Canada medical device licence, and in its December 2021 advisory Health Canada said that “to date, no microneedling devices have been authorized for at-home use”. Australia also requires a listing on its national register before a device can be supplied, and has penalized a seller over an unlisted Dermapen. The EU and Great Britain regulate the pen only when it is sold for a medical purpose. In Britain the newer rules are about the treatment rather than the device: Scotland passed a law in May 2026 that sends deep (1.5 mm or more) and radiofrequency microneedling into healthcare-led premises, and England’s licensing scheme is still being designed.

This page is the long version of the short “Outside the United States” section in our FDA clearance guide. Everything below was checked against the regulators’ own records on October 6, 2026, except where we say we could not reach them.

Summary by country

Canada Australia EU UK
Regulator Health Canada TGA National authorities under the MDR MHRA (devices); councils and Scottish Ministers (treatments)
Is a microneedling pen a medical device? Yes, a licence is needed to sell pens and cartridges Yes when supplied as a therapeutic good; must be on the ARTG Only if sold for a medical purpose Only if sold for a medical purpose
Class Class II on every licence we found (RF microneedling: Class III) Shown on each ARTG entry (not verified by us) Set by the MDR’s classification rules; Dermaroller states Class IIa Set by the UK rules; CE-marked devices keep their EU class
Public register MDALL ARTG EUDAMED PARD
Home use None authorized as of the 2021 advisory No rule found No rule found No rule on the device; Scotland and England regulate who treats others
Notable action 2021 Dr. Pen advisory; 2024 seizure of microneedles at an Alberta clinic 2019 Dermapen 4 register cancellation; 2020 penalties None found 2019 MHRA alert on Dermapen 3 devices and needle tips

Canada: Health Canada and the MDALL

What the law says

The decisive sentence is in Health Canada’s public advisory RA-63732 of December 16, 2021: “In Canada, microneedling pens and cartridges require a medical device licence from Health Canada to be sold.” The same advisory says Health Canada “has authorized microneedling devices for professional use only”, and adds that “to date, no microneedling devices have been authorized for at-home use, where there are higher health risks associated with inappropriate use, contamination, and infection.”

The advisory was about Dr. Pen. It covers the “Dr. pen Auto Microneedle System. All models, including but not limited to, A1, A6, A7, A6S, E30, M5, M7, M8, N2 and X5, and Ultima versions.” Health Canada said the pens had been found “online, at salons and spas, and by beauty academies”, that it was working with the Canada Border Services Agency to stop further imports, and that buyers should not use them.

Two things have changed since then. The advisory page is now marked “archived”, meaning it is kept for reference and has not been updated. And Dr. Pen’s manufacturer has since been licensed for some models (below). Health Canada has not published a newer statement on home use that we could find, so whether any licensed device is now authorized for home use is an open question. The licence records do not say who a device is for.

A second advisory, RA-75899 of August 2, 2024, involved a clinic in Sherwood Park, Alberta, where Health Canada seized “unauthorized medical devices including microneedles, microneedle tips, and a plasma pen”. It also notes that the licence number “is not required to appear on the product label”, which matters when you try to check a pen (see the steps below).

A search of Health Canada’s recalls and safety alerts site for “microneedling” (archived alerts included) returned only these two advisories.

Which devices hold a licence

Health Canada licenses Class II, III and IV devices. Class I devices need no device licence and do not appear in its database. Every microneedling pen, roller and stamp licence we found is Class II. The radiofrequency microneedling systems we found (Potenza, Intracel and Secret RF) are Class III.

Selected licences from MDALL, checked October 6, 2026:

Licence Name on the licence Holder Status First issued
99476 SkinPen Microneedling System with SkinPen + SkinFuse Treatment Kit Crown Aesthetics Active 2017-08-01
113914 SkinPen Precision Elite Microneedling System Crown Aesthetics Active 2025-09-03
99001 InnoPen System (company 132628) Active 2017-04-20
106831 DermapenWorld Dermapen4 (company 172498) Active 2021-10-13
108661 XCellarisPro Twist Microneedling-System (company 140539) Active 2022-12-16
115135 Dermalogica Pro Pen Microneedling (company 194801) Active 2026-03-31
114618 Microneedling System Guangzhou Ekai Electronic Technology (Dr. Pen) Active 2026-01-06
112281 Dr.Pen Microneedling System Guangzhou Ekai Electronic Technology Cancelled, no response to renewal 2024-11-27 to 2025-12-09

Rollers and stamps are licensed too, including at least four first issued in 2026 (for example licence 115337, the Angel Kiss Microneedling Roller).

The Dr. Pen licences are the ones most people ask about. Licence 114618 lists the A20, A9 and DP-MC9 handpieces and the H14 cartridge. The earlier licence 112281 also listed the A11, ran from November 27, 2024 to December 9, 2025, and now carries status “R”, which MDALL’s documentation defines as cancelled because a renewal got no response. So the A11 was licensed for about a year and lapsed. The M8, M8S, A6S, A10, X5, A7 and other models are on neither licence. For model-by-model detail see our reviews of the Dr. Pen A20 and Dr. Pen A11.

A licence can also be suspended. Four microneedling licences issued in 2025 (Pro MD Dermapen, Q-Dermapen, Kaloya and CitPen) show status “S”, suspended, with end dates in February or March 2026. One of those makers, Kaloya, holds a newer active licence (115293). A licence number alone is not enough: check its status.

Online listings often say “Health Canada licensed”. Google’s snippets for this search include an Amazon.ca pen sold “for At-Home Skin Care. Health Canada Licensed” and a Canadian retailer describing the A20 as “cleared by the FDA & Health Canada” for “professionals and home users alike”. The A20’s FDA clearance (K230420) is for prescription use, and the Canadian licence record states no intended user, so neither claim is something a buyer can confirm from the public records.

How to check a device in Canada

  1. Open MDALL at health-products.canada.ca/mdall-limh/ and use the active licence search.
  2. Search by company name or licence number, not only the brand. The current Dr. Pen licence is named “Microneedling System”, so a search for “Dr. Pen” returns only the cancelled one.
  3. Open the licence and read the device identifiers. The exact model and the cartridge should both be listed.
  4. Check the status: active, cancelled or suspended. The API shows it directly, for example https://health-products.canada.ca/api/medical-devices/licence/?id=114618&lang=en&type=json (licence) and https://health-products.canada.ca/api/medical-devices/deviceidentifier/?licence_id=114618&lang=en&type=json (models). Status “I” means issued and active.
  5. If a seller cannot give you a licence number that checks out, Health Canada’s advice in the 2021 advisory is not to buy, and to report unlicensed sales to Health Canada.
How to avoid scam on Dr Pen?
byu/pineapple_yoda inMicroneedling

Buying from the official seller and buying a licensed device are separate questions. A thread in r/Microneedling (shown above in a translated view) asks how to avoid being scammed on a Dr. Pen and how to know whether a website is legitimate; a Canadian buyer also needs the model to appear on a licence.

United Kingdom: device rules and treatment rules

The UK splits into two questions: is the pen a medical device, and who may use one on someone else.

The device

In Great Britain (England, Scotland and Wales), devices fall under the UK Medical Devices Regulations 2002. Whether a product is a medical device depends on its purpose. The MHRA’s borderline guidance says products without a medical purpose “are not considered to be medical devices”, and its list of products “not normally considered to be medical devices” includes “wrinkle treatments (with cosmetic purpose)” and “instruments for tattooing”. So a pen sold only for cosmetic use may sit outside the device rules, while the same pen sold to treat scars is a device. The guidance has no entry on microneedling itself.

Devices sold as medical devices in Great Britain can carry a UKCA mark or a CE mark. Under current law, CE-marked devices that comply with the older EU directive can be sold until their certificate expires or June 30, 2028, whichever is sooner, and devices that comply with the EU MDR until June 30, 2030. The MHRA consulted from February 16 to April 10, 2026 on accepting CE-marked devices indefinitely. Its consultation page, last updated March 19, 2026, showed no published outcome when we checked. Manufacturers must also register their devices with the MHRA, through a UK responsible person if they are based abroad. Northern Ireland follows EU device rules.

The MHRA has acted on Dermapen before. Its alert MDA/2019/028 of August 27, 2019 told users to stop using Dermapen 3 devices (serial numbers 3MD1605456 to 3MD1702134), three batches of Dermapen 3 needle tips, and all Dermapen Cryo devices, because “The devices’ packaging have a CE mark but this has not been obtained through appropriate regulatory oversight.” The alert names Equipmed, trading as DermapenWorld among other names, as the manufacturer, and Naturastudios as the UK distributor.

The treatment

Scotland now has a law. The Non-surgical Procedures and Functions of Medical Reviewers (Scotland) Act 2026 became an Act on May 12, 2026. Its schedule covers microneedling “to any depth if one or more microneedles are used to deliver radio frequency electromagnetic radiation, or … to a depth of 1.5 millimetres or more in any other case.” Those procedures will have to be done in “permitted premises”, essentially clinics led by a regulated healthcare professional, and under-18s may not be treated. The definitions came into force on July 22, 2026, but legislation.gov.uk still listed the premises and under-18 offences as not yet in force on October 6, 2026. Shallower microneedling without RF goes to a separate local licensing order (SSI 2026/87), which requires a licence from September 6, 2027.

England has the power but no scheme yet. The Health and Care Act 2022 lets the Health Secretary license non-surgical cosmetic procedures. The 2023 consultation proposed putting microneedling in the lowest-risk “green” tier, which any licensed practitioner could perform. Some respondents asked for it to be moved higher or split by depth. The government’s response of August 7, 2025 confirmed a three-tier system and said the design “will be subject to further public consultations” before Parliament debates it. We found no later consultation on GOV.UK.

Wales licenses four “special procedures” (acupuncture, body piercing, electrolysis and tattooing, including semi-permanent make-up) since November 29, 2024. Microneedling is not one of them.

Scotland’s offences apply to providing a procedure to another person, so they do not cover using a pen on yourself. England’s proposals are about licensing practitioners and premises.

How to check a device in the UK

  1. Look for a UKCA or CE mark with a four-digit body number next to it, and the manufacturer’s or UK responsible person’s details on the box.
  2. Search the MHRA’s public registration database (PARD, pard.mhra.gov.uk) for the manufacturer and device.
  3. Search GOV.UK’s medical device alerts for the brand name.
  4. Report problems through the MHRA’s Yellow Card scheme (yellowcard.mhra.gov.uk).
  5. For a treatment in Scotland, ask whether the procedure is deeper than 1.5 mm or uses RF, and if so whether the premises are a registered clinic.

European Union: the MDR

The EU’s Medical Device Regulation (2017/745) has applied since May 26, 2021. It covers a microneedling device when it is sold for a medical purpose, such as treating scars.

It also reaches some products with no medical purpose through Annex XVI, which lists six groups: contact lenses, implants that modify anatomy, dermal fillers, fat-reduction equipment, high-intensity light equipment such as lasers and IPL, and brain stimulation equipment. Microneedling is not one of the six. The Common Specifications for those groups (Implementing Regulation 2022/2346, applying from June 22, 2023) do not mention microneedling either, and the Commission’s borderline and classification manual (version 5, April 2026) has no entry on it. That leaves a gap we could not close: a pen sold purely as a cosmetic tool does not appear to be pulled into the MDR, and we found no EU document that says so directly. RF microneedling is a similar open point, since Annex XVI’s energy group names light sources, not radiofrequency.

Class follows the MDR’s rules. Rule 6 puts “surgically invasive devices intended for transient use” in Class IIa, with listed exceptions. Dermaroller GmbH, for example, describes its XCellarisPro Twist and medical rollers as “Class IIa medical device in Europe (93/42/EEC)”. That reference is to the older Medical Device Directive, not the MDR. Devices certified under the directive may stay on the market until December 31, 2028 for Class IIa, under conditions set by Regulation 2023/607, so older certificates are still legitimate for now.

EUDAMED is the EU’s device database. The Commission confirmed four of its modules (actors, devices, certificates and market surveillance) as functional in Decision 2025/2371, published November 27, 2025, which started the countdown to mandatory registration.

How to check a device in the EU

  1. Look for the CE mark and the notified body’s four-digit number (a Class IIa device needs one).
  2. Search EUDAMED (ec.europa.eu/tools/eudamed) for the manufacturer and device.
  3. Check whether the seller describes a medical purpose. If it sells the pen for scars or wrinkles but shows no CE mark, that is a mismatch.
  4. Report problems to the medical device authority in your own country.

Australia: the TGA and the ARTG

We could not open tga.gov.au on October 6, 2026. Every request from our systems timed out, including through a browser and through archive copies. The Australian facts below come from TGA releases republished verbatim, from trade press quoting the TGA, and from the titles of TGA pages as listed by search engines. Treat them as reported, not checked at the source.

Australia’s law, as the TGA put it in a February 10, 2020 release, “prohibits the import, export, manufacture, supply and advertising of therapeutic goods for human use that are not included in the ARTG or otherwise the subject of an exemption, approval or authority.” That release announced that InSkin Cosmedics Group had paid $37,800 in penalties over three infringement notices for supplying and advertising the Dermapen 4, which “was not included on the Australian Register of Therapeutic Goods (ARTG) at the relevant times.” The supply offences were dated February 22 and May 17, 2019. A second TGA release, which we know only by its title, reports that the same company was fined $25,200 “for alleged unlawful importation of cosmetic medical devices”.

Separately, Professional Beauty reported on November 20, 2019 that the Dermapen 4’s ARTG entry had been cancelled for “the failure of the sponsor … to provide information to the Secretary about the safety and efficacy of the product as required under section 41JA of the Therapeutic Goods Act.” The company called it “a dispute over the classification process” and “a paperwork issue rather than an issue with the device itself.” A TGA release titled “Microneedling device cancelled in Australia” exists; we could not read it. Whether the Dermapen 4 is back on the ARTG today is unverified.

ARTG entries for pens exist under the name “Electronic cosmetic micro-needling handpiece”, for example Dermalogica’s PRO Pen Microneedling System (ARTG 526922). The class on each entry is unverified by us. We found no Australian licence for beauty-salon microneedling comparable to Scotland’s.

Ready to start poking (more) holes in my head. Which pen – available on Amazon – is most recommended?
byu/brodealsurf intressless

A thread in r/tressless (shown in a translated view) about starting scalp microneedling with a Dr. Pen or a dermaroller links to tga.gov.au in its preview, so Australian buyers do go looking for the register.

How to check a device in Australia

  1. Ask the seller for the ARTG number.
  2. Search the ARTG on tga.gov.au by that number, the product name or the sponsor (the Australian company responsible for it).
  3. Check that the entry names the product you are buying, and note its class.
  4. Report problems or illegal advertising to the TGA.

Questions

Is any microneedling pen approved by Health Canada for home use? Not as of Health Canada’s December 2021 advisory, which said “no microneedling devices have been authorized for at-home use.” Several pens have been licensed since then, but the licence records do not state who the device is for, and Health Canada has published nothing newer on home use that we could find.

Is the Dr. Pen legal in Canada? Only some models. The A20 and A9 handpieces and the H14 cartridge are on active licence 114618. The A11 was licensed until December 9, 2025 and lapsed. Other Dr. Pen models, including the M8, are on no licence.

Is a CE mark enough to sell a pen in the UK? For now, yes, in Great Britain, if it is a valid CE mark under the EU rules and the device is registered with the MHRA. Acceptance currently ends in 2028 or 2030 depending on which EU rules the device meets; a proposal to make it indefinite was consulted on in 2026.

Do I need a licence to microneedle clients in Scotland? Not yet in practice. The 2026 Act sends deep and RF microneedling to healthcare-led premises once its offences come into force, and shallower microneedling will need a local licence from September 6, 2027.

Does the EU regulate cosmetic microneedling pens? Only partly. A pen sold for a medical purpose is a medical device under the MDR. Microneedling is not among the Annex XVI cosmetic product groups, so a purely cosmetic pen appears to fall outside it.

Sources

  • Health Canada, public advisory RA-63732, “Dr. pen microneedling devices are not authorized for sale and may pose health risks” (December 16, 2021, archived): https://recalls-rappels.canada.ca/en/alert-recall/dr-pen-microneedling-devices-are-not-authorized-sale-and-may-pose-health-risks
  • Health Canada, public advisory RA-75899, MedSkin Laser Center, Sherwood Park (August 2, 2024): https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-treatments-provided-individual-posing-practitioner-medskin-laser-center
  • Health Canada recalls search, “microneedling”, archived included: https://recalls-rappels.canada.ca/en/search/site?search_api_fulltext=microneedling&archive=1
  • Health Canada, Medical Devices Active Licence Listing (MDALL): https://health-products.canada.ca/mdall-limh/
  • Health Canada, MDALL API guide (licence classes, status codes): https://health-products.canada.ca/api/documentation/mdall-documentation-en.html
  • MDALL licence 114618: https://health-products.canada.ca/api/medical-devices/licence/?id=114618&lang=en&type=json and models: https://health-products.canada.ca/api/medical-devices/deviceidentifier/?licence_id=114618&lang=en&type=json
  • MDALL licence 112281: https://health-products.canada.ca/api/medical-devices/licence/?id=112281&lang=en&type=json and models: https://health-products.canada.ca/api/medical-devices/deviceidentifier/?licence_id=112281&lang=en&type=json
  • MDALL licences 99476 and 113914 (SkinPen): https://health-products.canada.ca/api/medical-devices/licence/?id=99476&lang=en&type=json and https://health-products.canada.ca/api/medical-devices/licence/?id=113914&lang=en&type=json
  • MDALL licence name searches (“microneedl”, “micro needl”, “dermapen”, “innopen”, “dermaroller”, “derma roller”, “derma stamp”), October 6, 2026: https://health-products.canada.ca/api/medical-devices/licence/?licence_name=microneedl&lang=en&type=json
  • MHRA, “Borderlines with medical devices and other products in Great Britain” (updated June 29, 2026): https://www.gov.uk/government/publications/borderlines-with-medical-devices/borderlines-with-medical-devices-and-other-products-in-great-britain
  • MHRA, “Regulating medical devices in the UK”: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk
  • MHRA, “Timelines for acceptance of CE marked medical devices in Great Britain” (February 16, 2026): https://www.gov.uk/government/publications/timelines-for-acceptance-of-ce-marked-medical-devices-in-great-britain-gb/timelines-for-acceptance-of-ce-marked-medical-devices-in-great-britain-gb
  • MHRA, targeted consultation on indefinite recognition of CE marked devices: https://www.gov.uk/government/consultations/medical-devices-regulations-targeted-consultation-on-the-indefinite-recognition-of-ce-marked-devices
  • MHRA, MDA/2019/028, Dermapen 3 and Dermapen Cryo (August 27, 2019): https://www.gov.uk/drug-device-alerts/microneedling-pens-dermapen-3-and-dermapen-cryo-sterile-single-use-needle-cartridge-tips-for-dermapen-3-risk-of-injury-or-infection-mda-2019-028
  • MHRA Public Access Registration Database: https://pard.mhra.gov.uk/
  • MHRA Yellow Card: https://yellowcard.mhra.gov.uk/
  • DHSC, “The licensing of non-surgical cosmetic procedures in England: consultation response” (August 7, 2025): https://www.gov.uk/government/consultations/licensing-of-non-surgical-cosmetic-procedures/outcome/the-licensing-of-non-surgical-cosmetic-procedures-in-england-consultation-response
  • Non-surgical Procedures and Functions of Medical Reviewers (Scotland) Act 2026 (asp 13): https://www.legislation.gov.uk/asp/2026/13/contents
  • Scottish Parliament, bill page and stages: https://www.parliament.scot/bills-and-laws/bills/s6/non-surgical-procedures-and-functions-of-medical-reviewers-scotland-bill
  • Civic Government (Scotland) Act 1982 (Licensing of Non-surgical Procedures) Order 2026 (SSI 2026/87): https://www.legislation.gov.uk/ssi/2026/87/contents
  • Welsh Government, “Licensing scheme for special procedures” (updated July 30, 2026): https://www.gov.wales/licensing-scheme-special-procedures
  • Regulation (EU) 2017/745 (MDR), Annex VIII Rule 6: http://publications.europa.eu/resource/celex/32017R0745
  • MDR Annex XVI, as adopted: https://www.legislation.gov.uk/eur/2017/745/annex/XVI/adopted
  • Commission Implementing Regulation (EU) 2022/2346, common specifications for Annex XVI products: http://publications.europa.eu/resource/celex/32022R2346
  • Regulation (EU) 2023/607, MDR transition extension: http://publications.europa.eu/resource/celex/32023R0607
  • Commission Decision (EU) 2025/2371 on EUDAMED functionality: http://publications.europa.eu/resource/celex/32025D2371
  • European Commission, Manual on borderline and classification, version 5 (April 2026): https://health.ec.europa.eu/latest-updates/update-manual-borderline-and-classification-under-regulations-eu-2017745-and-2017746-v5-2026-04-22_en
  • EUDAMED public site: https://ec.europa.eu/tools/eudamed/
  • Dermaroller GmbH, medical microneedling devices (checked October 6, 2026): https://www.dermaroller.com/en/archive/medical-microneedling/devices
  • TGA release “InSkin Cosmedics Group pays $37,800 in penalties…” (February 10, 2020), as republished verbatim by Mirage News: https://www.miragenews.com/inskin-cosmedics-group-pays-37-800-in-penalties-for-alleged-supply-and-advertising-of-unapproved-dermapen-device/ (original: https://www.tga.gov.au/news/media-releases/inskin-cosmedics-group-pays-37800-penalties-alleged-supply-and-advertising-unapproved-dermapen-device, not reachable from our systems)
  • TGA release “Inskin Cosmedics Group fined $25,200 for alleged unlawful importation of cosmetic medical devices” (title only; not reachable): https://www.tga.gov.au/news/media-releases/inskin-cosmedics-group-fined-25200-alleged-unlawful-importation-cosmetic-medical-devices
  • TGA release “Microneedling device cancelled in Australia” (not reachable): https://www.tga.gov.au/news/media-releases/microneedling-device-cancelled-australia
  • Professional Beauty, “Dermapen 4 loses TGA approval – temporarily” (November 20, 2019): https://www.professionalbeauty.com.au/beauty/dermapen-4-loses-tga-approval-temporarily/
  • ARTG entry 526922, Dermalogica PRO Pen (title only; not reachable): https://www.tga.gov.au/resources/artg/526922

This page is for information only and is not legal or medical advice.