I started doing some research after noticing that there were questionable Dr. Pens on online marketplaces such as eBay and Amazon. In an effort to avoid low-quality products that could leave scarring, I took a deep dive into microneedling regulations in Australia, Canada, and the USA (I’m in a policy master's degree lol). Below is a summary of what I found:

Canada:

Health Canada approves medical devices. They have not approved any microneedling pens for home use (due to risks from improper use or low-quality devices). This means Dr. Pens are illegal to be marketed in Canada. If you see a Dr. Pen vendor in Canada, it’s probably an illegal (although this is poorly enforced and Dr. Pens are often sold in Canada). Proceed with caution if you are planning to buy any at-home microneedle pen from a Canadian vendor. Also, Health Canada says they are working with border patrol agencies to stop these products from being imported. Order them at your own risk. (Reference: Dr. pen microneedling devices are not authorized for sale and may pose health risks - Canada.ca). Another note on Dr Pen in Canada, I was unable to find the Australian company that supplies Dr. Pens (ESHOPPING GROUP PTY LTD) as registered in Canada (Canada's Business Registries (canadasbusinessregistries.ca).

TL;DR –Microneedling pens are not approved for home use in Canada, including Dr. Pens.

Australia:

The ARTG approves medical devices in Australia. Dr. Pens are authorized for sale in Australia. When searching the ARTG, search for ESHOPPING GROUP PTY LTD. You’ll find that their microneedling pens (and cartridges) have been authorized for sale in Australia since February 2020. Their ARTG IDs are 330372 and 337693, respectively. I did not verify that the site that sells Dr. Pens in Australia is registered to ESHOPPING GROUP PTY LTD (Dr Pen Microneedling System | Microneedling Pen). Note that Dermapen 4, a microneedling pen curently sold in the UK, was removed from the ARTG in 2020 for failing to provide updated information on their product. These Dr. Pens can be shipped to Canada. (Reference: ARTG Search · Custom Portal (health.gov.au), ESHOPPING GROUP PTY LTD - Electronic cosmetic micro-needling handpiece (330372) | Therapeutic Goods Administration (TGA), , Are your products registered? : Dr. Pen Support (drpen.com.au), Microneedling: Things to consider | Therapeutic Goods Administration (TGA), and others if needed)

TL;DR – Dr. Pens and their cartridges are regulated and authorized for sale in Australia. They can be shipped internationally.

USA:

The FDA regulates medical devices. They released a statement saying that microneedling has not been approved for hairloss (although they acknowledge that clinical studies are underway). They clarify that they have not tested microneedling for hairloss as the reason it could not be approved. It has been approved for certain skin conditions on certain areas of the body. I did not perform an exhaustive search of which products are approved by the FDA. (References: Microneedling Devices: Getting to the Point on Benefits, Risks and Safety | FDA, Microneedling Devices | FDA). In particular, Dr. Pen has been approved by the FDA as a “pressure applying device” but is seeking reclassification. Sales have allegedly halted, but will resume once reclassification is complete. The Australian Company (ESHOPPING GROUP PTY LTD) was registered in the USA in 2022 (Ref. FDA Related FAQ – Dr Pen US, Establishment Registration & Device Listing (fda.gov)).

TL;DR: Microneeedling for hairloss is not approved in the USA. Dr. Pen is allegedly pursuing FDA reclassification to resume USA sales.

All 3 Countries:

If the needles do not pierce the skin, then it is not considered a health device. They are unregulated and generally considered low risk. This applies to many dermarollers.

Limitations:

Dr. Pen may be authorized for sale in other jurisdictions with high medical device standards (such as the UK). I didn’t examine those countries’ microneedling regulations or Dr. Pen’s status there. MY examination should not be taken as conclusive evidence for or against the purchase of a Dr. Pen product, as more research should be undertaken.

Conclusions / TL;DR:

Check to see if the microneedling pen you plan to buy is approved for use wherever you live. Check with Health Canada in Canada, FDA in USA, ARTG in Australia. That way you can avoid risks from low quality products. Dr. Pen is currently only authorized in Australia and is apparently seeking reclassification in the USA to resume sales.

UK Update:
Dr. Pen is not registered with UK's medical device organization, the MHRA. (https://aic.mhra.gov.uk/era/pdr.nsf/Search?SearchView&Query=/era/pdr.nsf/Search?SearchView&Query=[DevCode]Contains(cosmetic micro)&SearchOrder=4&SearchOrder=4)).

Australia update:
I just noticed that Dr Pen cartridges and pens have a Class 1 medical device certification in Australia. They do not have a Class 1 (sterile) certification. I'm not sure what this means exactly, but I'm assuming it means that the product does not have to be sterile. This raises concerns about infections.

Disclaimer: This does not constitute legal or medical advice, just in case anyone thought it did.