Counterfeit Devices in Clinics: The Licence Checks Importers and Distributors Must Run

In September 2026, Health Canada issued a public advisory after counterfeit Soprano laser hair removal and therapy devices were found in clinics in Canada. The genuine Soprano devices are made by Alma Lasers Ltd. The counterfeit units carried a label naming Beijing Perfectlaser Technology Co., Ltd. as the manufacturer, and that company provided a falsified medical device licence and falsely represented the products as authorized. The authentic manufacturer confirmed the devices were counterfeit.

For importers, distributors and the clinics that buy equipment, the advisory is a warning that a professional-looking device, a brand name and a licence number on paper are not proof of anything. A counterfeit device can enter the supply chain with forged documents and reach a treatment room before anyone checks it against Health Canada's own records. The good news is that the check that would have caught it is quick, free and public.

This article explains what Health Canada found, why a counterfeit device is a licensing failure as much as a product one, and the exact licence checks that importers, distributors and clinics should run before they buy, import or use a medical device in Canada.

Executive summary

What Health Canada found: counterfeit Soprano devices in clinics

What is it? A Health Canada public advisory about counterfeit laser hair removal and therapy systems sold under the Soprano brand and found in Canadian clinics. Why it matters: the devices were sold with a falsified medical device licence, and Health Canada warns that counterfeit products may pose serious health risks because their safety and effectiveness are unknown.

According to the public advisory, the authentic Soprano devices are manufactured by Alma Lasers Ltd., while the counterfeit units were labelled as made by Beijing Perfectlaser Technology Co., Ltd. Health Canada states that this company provided a falsified medical device licence and falsely represented the products as authorized medical devices, which may mislead purchasers into believing the device meets regulatory requirements when it does not. The advisory is blunt about the risk: counterfeit health products are imitations of authentic products but are not the same, and may pose serious health risk due to their unknown safety and effectiveness. The sale of counterfeit health products is illegal in Canada.

The table below sets out the practical signals the advisory points to. None of them is visible from a glossy brochure, which is exactly the problem.

Signal	What the advisory says	What it means for a buyer
Manufacturer on the label	Authentic Soprano is made by Alma Lasers Ltd.; counterfeit units named Beijing Perfectlaser Technology Co., Ltd.	Check the manufacturer name on the permanent label, not the brand on the marketing
The licence	A falsified medical device licence was provided	A licence number on paper is not proof; verify it against Health Canada records
Authenticity	The authentic manufacturer confirmed the units were counterfeit	When in doubt, contact the genuine manufacturer
Legality	Selling counterfeit health products is illegal in Canada	Possessing and using one exposes a clinic to risk and removal from service

Why a counterfeit device is a licensing failure, not just a product problem

What is it? In Canada, medical devices are regulated under the Medical Devices Regulations (SOR/98-282). How it affects compliance: a device must hold the right licence, and the companies that import and distribute it must hold their own establishment licence and verify what they handle. A falsified licence defeats all of that only if nobody checks the records.

Two different licences matter here. A medical device licence (MDL) is issued for a specific Class II, III or IV device and is listed publicly. A Medical Device Establishment Licence (MDEL) is held by the company that imports or distributes devices, and by manufacturers of Class I devices. Laser hair removal systems are medical devices in Canada, so a legitimate unit sits behind a real device licence, and a legitimate importer or distributor sits behind a real establishment licence. A counterfeit device with a forged licence breaks the chain at the device level, and a distributor who does not verify the records lets the break pass through to the clinic.

This is why the 2026 MDEL amendments matter to every importer and distributor. Establishment licensing is not a one-time registration. It carries ongoing duties: handling complaints, keeping distribution records, running recalls and reporting problems under the recall and reporting rules in SOR/98-282. A company that cannot trace which units it imported, from whom, cannot act when an advisory like this one lands.

How to verify a device is licensed: the MDALL check

What to do: before you buy, import or use a device, compare the manufacturer name, device name and model or catalogue identifier on the permanent label against Health Canada's Medical Devices Active Licence Listing. If they do not match, stop.

Health Canada's Medical Devices Active Licence Listing (MDALL) is a free, public database of licensed Class II, III and IV devices. It is the single most useful counterfeit check available, and the advisory points to it directly. The steps below turn it into a repeatable control.

Read the permanent label on the device, not the brochure. Record the manufacturer name, the device name and the model or catalogue identifier exactly as printed.
Search MDALL by device name, licence number or company, and open the matching active licence.
Confirm the manufacturer name on the licence matches the manufacturer on the label. A brand you recognize with a manufacturer you do not is a red flag.
Confirm the device name and model or catalogue identifier are covered by that licence.
If anything does not match, do not buy or use the device. Contact the genuine manufacturer to confirm authenticity, and report the device to Health Canada.
Keep a dated record of the check, with the licence number and who performed it, as evidence of due diligence.

What importers and distributors must do: supplier due diligence

Why it matters: importers and distributors are the gate between a foreign manufacturer and a Canadian clinic. A Medical Device Establishment Licence brings duties that, done properly, would stop a counterfeit device before it is sold.

Beyond the MDALL check on each device, an MDEL holder should be able to show the following controls when Health Canada asks. Health Canada works with the Canada Border Services Agency to help prevent the import of unauthorized health products, so a clean import trail matters at the border as well as in an inspection.

MDEL obligation	What good practice looks like
Supplier qualification	Documented checks on each manufacturer and the licence status of every device before first purchase
Distribution records	Records that let you trace which units went to which customer, and recall them quickly
Complaint handling	A procedure that captures, assesses and escalates device complaints without delay
Mandatory problem reporting	A process to report device problems and incidents to Health Canada within the required timelines
Recall capability	A tested recall procedure you can run against your distribution records

A counterfeit device is also a traceability test. When an advisory names a product, the importers and distributors who can answer within hours are the ones who kept proper records. Readers who manage device recalls will recognize the same discipline from serial-number recalls and UDI traceability. If your intake process cannot tell you where a suspect unit went, the counterfeit problem becomes a recall problem you cannot execute.

Clinics and aesthetic businesses are buyers too

What to do: treat every piece of treatment equipment as a regulated medical device, run the same MDALL check a distributor should run, and keep proof that you did it before the device goes into a treatment room.

The counterfeit Soprano units reached clinics, not warehouses, which makes the clinic the last line of defence and the place where patient harm actually happens. A medical spa or dermatology clinic that buys a laser system is a purchaser of a regulated device, and the licence check is just as much its job as the distributor's. Price is often the lure. A deal that undercuts the market by a wide margin is a reason to verify harder, because a genuine, licensed device carries the cost of a real manufacturer and a real quality system behind it.

A clinic that uses an unverified or counterfeit device is exposed on several fronts at once. The device may be unsafe because its true performance is unknown, the clinic may be using an unauthorized device in breach of the rules, and any patient injury becomes both a clinical and a regulatory problem. The advisory is clear that patients with concerns such as pain, skin reddening or swelling after treatment should consult a licensed healthcare professional, which means a counterfeit device can turn into a wave of patient follow-up the clinic did not plan for. A five minute licence check at the point of purchase is cheap insurance against all of it.

Counterfeit device prevention: compliance checklist

Use this checklist to keep counterfeit and unauthorized devices out of your supply chain and your clinic.

Every device is checked against Health Canada's Medical Devices Active Licence Listing before purchase, import or first use.
The manufacturer name, device name and model or catalogue identifier on the permanent label match the active licence.
A licence number supplied by a seller is verified against MDALL, never accepted on paper alone.
Suppliers are qualified and documented before first purchase, including the licence status of each device.
Distribution records can trace every unit from supplier to customer for recall.
A complaint-handling and mandatory problem-reporting procedure is in place and used.
A recall procedure is documented and has been tested against real records.
Staff know to stop using, isolate and report any device suspected of being counterfeit.
Dated evidence of each licence check is retained as proof of due diligence.

Common mistakes that let counterfeit devices through

Trusting the brand, not the label. A recognized brand name on marketing material tells you nothing about the manufacturer printed on the device.
Accepting a licence number on paper. The counterfeit seller supplied a falsified licence. Only a match against MDALL counts.
Buying on price without supplier qualification. A price well below market is a reason to verify harder, not to move faster.
No distribution records. Without traceability, you cannot answer an advisory or run a recall when a counterfeit is found.
Treating the clinic as the end of the chain. Clinics are purchasers too, and should run the same MDALL check before putting a device into service.

Frequently asked questions

How do I check if a medical device is licensed in Canada?

Use Health Canada's Medical Devices Active Licence Listing (MDALL), a free public database of licensed Class II, III and IV devices. Compare the manufacturer name, device name and model or catalogue identifier on the device's permanent label against the active licence. If they do not match, do not buy or use the device.

Are the Soprano laser devices counterfeit?

Health Canada advised that counterfeit laser hair removal and therapy devices sold under the Soprano brand were found in clinics. The authentic Soprano devices are made by Alma Lasers Ltd. The counterfeit units were labelled as made by Beijing Perfectlaser Technology Co., Ltd., which provided a falsified medical device licence. The genuine manufacturer confirmed the units were counterfeit.

What is the difference between an MDL and an MDEL?

A medical device licence (MDL) authorizes a specific Class II, III or IV device and is listed in MDALL. A Medical Device Establishment Licence (MDEL) is held by companies that import or distribute devices, and by manufacturers of Class I devices. A legitimate device needs the right MDL, and a legitimate importer or distributor needs an MDEL.

What should a clinic do if it has a counterfeit device?

Stop using the device immediately and isolate it so it cannot be used. Dispose of it safely, contact the genuine manufacturer if you are unsure about authenticity, and report the device to Health Canada. Patients with concerns such as pain, skin reddening or swelling after treatment should consult a licensed healthcare professional.

Who is responsible when a counterfeit device reaches a clinic?

Everyone in the chain has a role. Importers and distributors hold an establishment licence and must qualify suppliers and verify device licences. Clinics should run their own MDALL check before buying. A falsified licence is the seller's fraud, but the controls that catch it belong to the buyers and distributors.

Does Health Canada work with border agencies on counterfeit devices?

Yes. Health Canada works with the Canada Border Services Agency to help prevent the import of unauthorized health products. A documented import trail and supplier qualification process help importers stay on the right side of that cooperation.

How MFLRC can help

MFLRC helps importers, distributors and clinics build the controls that keep counterfeit and unauthorized devices out. Our regulatory affairs, licensing and import and export team supports Medical Device Establishment Licence applications and amendments, supplier qualification and import compliance. Our audit and inspection-readiness team runs gap assessments on your distribution records, complaint handling and recall capability, and our quality assurance services build the SOPs that turn an MDALL check into a repeatable control.

Whether you import a single product line or distribute across the country, we help you verify what you handle and prove it. Learn more about our work with medical device companies.

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Conclusion

The counterfeit Soprano advisory is a reminder that in a regulated market, documents can be forged but public records cannot. A counterfeit device reached Canadian clinics behind a falsified licence, yet the check that exposes it is free and takes minutes: compare the permanent label against Health Canada's Medical Devices Active Licence Listing. Importers and distributors who qualify their suppliers, verify every licence and keep traceable records will catch the next counterfeit before it reaches a patient. Those who trust the paperwork will not.