Health Canada Now Licenses the Dr. Pen A20 and A9

Byadmin

Since January 6, 2026, two Dr. Pen handpieces, the A20 and A9, have held an active Health Canada medical device license (number 114618). That is a reversal for part of a brand that Health Canada told Canadians on December 16, 2021 not to buy or use, because “Dr. pen microneedling pens and cartridges are not licensed by Health Canada.” Every other Dr. Pen model is still unlicensed in Canada.

What the 2021 advisory said

Health Canada’s advisory covered 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.” Its instruction to the public was: “Do not use these unauthorized medical devices.”

Health Canada said it had received complaints, including reports from local public health units, about pens and cartridges sold online, in salons and spas, and through beauty academies. It added that “to date, no microneedling devices have been authorized for at-home use” in Canada.

Health Canada’s own copy of the advisory, on its recalls and safety alerts site, now carries an “archived” banner. The page defines archived material as “provided for reference, research or recordkeeping purposes” and says it “has not been altered or updated since it was archived.” Its last-updated date is still December 16, 2021. The page does not say the advisory has been withdrawn.

What the license records show

Health Canada’s Medical Devices Active Licence Listing (MDALL) holds two Dr. Pen licenses, both issued to Guangzhou Ekai Electronic Technology Co., Ltd., the same company named as applicant on the Dr. Pen A20’s FDA clearance.

License Name on record Class Dates Device identifiers
114618 Microneedling System II From January 6, 2026, no end date A20, A9, DP-MC9 (handpiece); H14 (cartridge)
112281 Dr.Pen Microneedling System II November 27, 2024 to December 9, 2025 A11, A20, A9 (handpiece); H14 (cartridge)

The handpiece entries sit under the trade name “DR. PEN HANDPIECE” and the cartridge under “DR.PEN MICRONEEDLING CARTRIDGE”. The record does not say what DP-MC9 is.

The A20 and A9 have been on a Canadian license since November 2024, apart from four weeks between December 9, 2025, when license 112281 ended, and January 6, 2026, when 114618 began. The A11 was on the earlier license for just over a year and is not on the current one.

The same company holds one more active license, 114768, issued January 30, 2026, for a device family named “MICRONEEDLING ROLLER”. It lists 30 identifiers in three series (D-MCA192, D-MCB192 and G-MC192), each in sizes labeled 0.2MM to 2.5MM. That record does not use the Dr. Pen name, so whether these rollers are sold as Dr. Pen products is unverified.

Which models the advisory still describes

The advisory’s stated reason was that Dr. Pen pens were not licensed. For the A20 and A9, sold with the H14 cartridge, that is no longer true. For every other model it still is:

  • Named in the advisory and on neither license: A1, A6, A7, A6S, E30, M5, M7, M8, N2, X5 and the Ultima versions.
  • Covered by “all models, including but not limited to” and on neither license: the M8S and A10, among others.
  • Licensed for a year, then not: the A11. Our A11 review notes it is sold in the US as the “A11 Ultima PRO”, which puts it under the advisory’s “Ultima versions” wording as well as “all models”.

Only the H14 cartridge is on the license. Dr. Pen sells other cartridge sizes for the A20 (listed in our A20 review), and none of them appear on either record.

What it means for buyers

In Canada, a Dr. Pen other than the A20 or A9 is an unlicensed medical device, which is the situation the 2021 advisory described. MDALL is public, and any model number can be checked there before buying.

The license does not say who it is for. The MDALL records list the license name, class, dates and model identifiers. They do not state an intended use, and they do not say whether home use is covered. The advisory’s 2021 statement that no microneedling device was authorized for home use has not been updated on the record.

In the US, the A20 is also the only Dr. Pen with an FDA clearance (K230420, granted August 11, 2023), and that clearance is for prescription use on facial acne scars. The A9 has no FDA clearance. Our Dr. Pen brand page covers every model’s status, and the Dr. Pen A20 review explains what the US clearance does and does not cover.

No company response was sought: this post reports regulator records.

Last updated: October 6, 2026. MDALL records checked October 6, 2026; Health Canada last refreshed both license records on October 5, 2026.

Sources

  • Health Canada advisory, “Dr. pen microneedling devices are not authorized for sale and may pose health risks”, December 16, 2021 (newswire release, checked 2026-10-06): https://www.newswire.ca/news-releases/advisory-dr-pen-microneedling-devices-are-not-authorized-for-sale-and-may-pose-health-risks-898811970.html
  • Health Canada, Recalls and safety alerts, same advisory, marked “archived”, last updated 2021-12-16 (checked 2026-10-06): https://recalls-rappels.canada.ca/en/alert-recall/dr-pen-microneedling-devices-are-not-authorized-sale-and-may-pose-health-risks
  • Health Canada MDALL, license 114618 (checked 2026-10-06): https://health-products.canada.ca/api/medical-devices/licence/?id=114618&state=active&lang=en&type=json
  • Health Canada MDALL, device identifiers on license 114618 (checked 2026-10-06): https://health-products.canada.ca/api/medical-devices/deviceidentifier/?licence_id=114618&lang=en&type=json
  • Health Canada MDALL, trade names on license 114618 (checked 2026-10-06): https://health-products.canada.ca/api/medical-devices/device/?licence_id=114618&lang=en&type=json
  • Health Canada MDALL, license 112281 (checked 2026-10-06): https://health-products.canada.ca/api/medical-devices/licence/?id=112281&lang=en&type=json&state=archived
  • Health Canada MDALL, device identifiers on license 112281 (checked 2026-10-06): https://health-products.canada.ca/api/medical-devices/deviceidentifier/?licence_id=112281&lang=en&type=json&state=archived
  • Health Canada MDALL, device identifiers on license 114768, “Microneedling Roller” (checked 2026-10-06): https://health-products.canada.ca/api/medical-devices/deviceidentifier/?licence_id=114768&lang=en&type=json
  • Health Canada MDALL, license holder record, company 148610 (checked 2026-10-06): https://health-products.canada.ca/api/medical-devices/company/?id=148610&lang=en&type=json
  • FDA 510(k) K230420, Dr. pen Microneedling System, summary: https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230420.pdf

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