A Canadian dental clinic does not need an establishment licence to buy gloves, masks or instrument pouches — the establishment that imports or distributes those devices into Canada does. The United States regulates the same activities through a different mechanism: establishment registration plus device listing, an annual registration fee, and a renewal window that opens every October. This comparison works through both regimes clause by clause — who must hold what, how each side classifies devices, what has to be true before a device can legally be imported, and what each statute says happens when it is not.
CliniEco Medical writes this from the buyer's side of the transaction. If you run a clinic, the regulatory question you actually face is not "am I licensed" but "is the party selling to me holding what it is supposed to hold, and can I check?"
The two regimes at a glance
| Question | Canada — Medical Devices Regulations, SOR/98-282 | United States — 21 CFR Part 807 |
|---|---|---|
| Instrument the establishment must hold | An establishment licence under section 44 | Establishment registration plus device listing under 807.20 |
| What the authorisation attaches to | The establishment and its activity (importation, distribution, or both) | The establishment, with devices listed against it |
| Stated exemptions | Retailers and health care facilities (section 44(2)) | Licensed practitioners, pharmacies and similar retail sellers (807.65) |
| Renewal clock | Annual review of the licence under section 46.1 | Annual registration between October 1 and December 31 (807.22(b)(1)) |
| Published fee | $4,590 for examination of the application or the annual review | $11,423 annual establishment registration fee for FY 2026 |
| Import precondition | The importer holds a licence and must ensure its supplier holds one (section 44(1), 44(3)) | The device is listed and was made at a registered foreign establishment (807.40(c)) |
| Foreign manufacturer link | Manufacturer is named in the licence application (section 45(d)) | A single United States agent must be designated (807.40(b)) |
Two regulators, two different legal objects
Canada's Medical Devices Regulations are made under the Food and Drugs Act. Section 44(1) of the Regulations reads, in full: "No person shall import or sell a medical device unless the person holds an establishment licence." That is a prohibition on an activity, enforced against the establishment performing it. The licence does not attach to a product; a distributor with an establishment licence can handle any class of device, provided the higher-class products themselves carry the manufacturer's device licence.
The United States uses a registration and a listing instead. The title of 21 CFR Part 807 is "Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices." Under 807.20(a), an owner or operator engaged in the manufacture, preparation, propagation, compounding, assembly or processing of a device intended for human use must register and submit listing information for those devices in commercial distribution. Registration is the establishment's identity with the agency; the listing is the device-by-device inventory attached to it. Neither is described as an approval of the product.
That distinction matters commercially. A registration number is not a statement that a device is safe, effective or cleared for marketing — a point the agency's own registration pages make explicit.
Who must hold what: the applicable entities
The two regimes divide "the trade" differently enough that a supplier can be compliant on one side of the border and not the other.
| Entity | Canada (SOR/98-282) | United States (21 CFR 807) |
|---|---|---|
| Class I manufacturer | Establishment licence required, unless it imports or distributes solely through a licensed person (section 44(2)(d)) | Register and list (807.20(a)(1)–(3)) |
| Class II, III or IV manufacturer | No establishment licence needed for its own sale (section 44(2)(c)); the device itself must carry a medical device licence (section 26) | Register, list, and hold the applicable clearance (510(k), De Novo or PMA) before commercial distribution |
| Importer | Establishment licence required (section 44(1)); must also ensure the party it imports from holds one (section 44(3)) | Initial importers must register and list (807.20(a)(5)) |
| Distributor that does not import | Covered by the same activity prohibition in section 44(1) | A domestic distributor that does not import devices is not required to register |
| Retailer | Expressly exempt (section 44(2)(a)) | Pharmacies, surgical supply outlets and similar retail establishments making final delivery or sale to the end user are exempt (807.65(e)) |
| Health care facility / clinic | Expressly exempt (section 44(2)(b)) | Exempt for dispensing to the consumer (807.65(i)) |
| Licensed practitioner | Not separately addressed; the facility exemption covers the practice | Physicians, dentists and optometrists who make or alter devices solely for use in their practice are exempt (807.65(d)) |
| Foreign manufacturer | Reaches the Canadian market through a licensed importer or distributor; a foreign applicant may submit a recognised regulatory authority's certificate of compliance (section 33) | Must register and list, and must designate one United States agent resident or with a place of business in the United States (807.40(a)–(b)) |
Read the clinic row carefully, because it is where most buying-side confusion starts. In Canada a health care facility is exempt from the establishment licence requirement for its own importation and sale. In the United States the equivalent outcome comes from the dispensing exemption, supplemented by the practitioner exemption. Neither exemption says anything about whether the supplies arriving at your loading door came through a compliant chain — that is what the supplier-side rows are for.
How each system classifies devices
Classification drives everything downstream, and the two schemes do not map onto each other row by row.
Canada uses four classes. Section 6 of the Regulations states that medical devices are classified into one of Classes I to IV by means of the classification rules in Schedule 1, "where Class I represents the lowest risk and Class IV represents the highest risk." Section 7 adds a tiebreaker: a device that can fall into more than one class takes the class representing the higher risk.
The United States uses three classes, and the premarket pathway depends on which one applies — a 510(k) premarket notification, a De Novo request, or a Premarket Approval application. A 510(k) clearance means the device was found substantially equivalent to a legally marketed predicate device, as set out in 807.100(a).
| Dimension | Canada | United States |
|---|---|---|
| Number of classes | Four (I to IV) | Three (I, II, III) |
| Governing instrument | Schedule 1 classification rules, sections 6–7 | Statutory class assigned by regulation |
| Highest-risk class | Class IV | Class III |
| Multiple-class rule | Higher-risk class applies (section 7) | Class determined by the device's regulatory classification |
| Product-level authorisation | Medical device licence for Class II–IV (section 26) | 510(k), De Novo or PMA depending on class |
For a clinic or a distributor the practical consequence is simple: a document that describes a product as "Class II" is ambiguous until you know which country's scheme is being cited. Ask which regulator issued the number, and what the number is for.
Import requirements: what has to be true before the border
Canada's import rule is built around the licence chain. Section 44(1) prohibits importation without an establishment licence, and section 44(3) adds an upstream duty: any person who imports a medical device must ensure that the person from whom they import it holds an establishment licence. Section 44(4) carves out two situations — importing a Class I device from its manufacturer when the importer itself holds a licence, and importing a Class II, III or IV device from its manufacturer.
The American import rule is built around listing and registration. Under 807.40(c): "No device may be imported or offered for import into the United States unless it is the subject of a device listing as required under subpart B of this part and is manufactured, prepared, propagated, compounded, or processed at a registered foreign establishment." The same section requires the foreign establishment to name a single United States agent who resides or maintains a place of business in the United States, and requires changes to that agent's name, address or phone number to be reported within 10 business days.
Two structural differences are worth holding on to. Canada's rule creates an obligation on the buyer of an import to verify the seller's status; the United States rule creates conditions on the goods themselves. And Canada routes the foreign manufacturer through a Canadian licence holder, while the United States requires the foreign establishment to appear in the register in its own right, with a domestic agent as the contact point.
Fees, renewals and the annual clocks
| Item | Canada | United States |
|---|---|---|
| Published fee | $4,590 for examination of an establishment licence application or its annual review | $11,423 annual establishment registration fee for fiscal year 2026 (October 1, 2025 to September 30, 2026) |
| Fee instrument | Fees in Respect of Drugs and Medical Devices Order, section 71(1) | Medical device user fee setting published by the agency |
| Adjustment mechanism | Every fee in the Order is adjusted each April 1 by the change over 12 months in the April All-items Consumer Price Index for Canada, rounded up to the nearest dollar (section 4(1)) | Fees are reset for each fiscal year |
| Renewal window | Annual review of the licence, filed under section 46.1 | Annual registration between October 1 and December 31 each fiscal year (807.22(b)(1)) |
| Late-change duty | Application content set out in section 45 | Registration updates within 30 days of a change (807.22(b)(2)) |
| Small-business relief | 25% reduction for businesses meeting the small-business definition in the Order | Small Business Determination program |
One caution on the Canadian figure. The $4,590 is the amount set out in the Order; section 4(1) of that Order indexes every fee to the April All-items Consumer Price Index each year, so the amount payable in a given fiscal year can differ from the number printed in the regulation. Treat the Order as the legal basis and the fee schedule as the current price, and check both before you budget.
Enforcement: what the statutes actually say
| Jurisdiction | Provision | Exposure |
|---|---|---|
| Canada | Food and Drugs Act, section 31.2, contravention relating to a therapeutic product | On indictment, a fine of up to $5,000,000 or imprisonment of up to two years, or both; on summary conviction, a first offence up to $250,000 or six months, and a subsequent offence up to $500,000 or 18 months |
| Canada | Food and Drugs Act, section 31.4, knowingly or recklessly causing a serious risk of injury to human health | On indictment, a fine at the court's discretion or imprisonment of up to five years, or both; on summary conviction, up to $500,000 or 18 months for a first offence |
| United States | 21 U.S.C. 331(p), failure to register as required by section 360 | A prohibited act |
| United States | 21 U.S.C. 333(a), violation of a prohibited act | Up to one year imprisonment or a fine of up to $1,000, or both; up to three years or $10,000, or both, after a prior conviction or where the violation was committed with intent to defraud or mislead |
The device-specific detail that makes these provisions apply here is definitional. In the Food and Drugs Act, "therapeutic product" is defined as a drug or device or any combination of drugs and devices, which is how the medical device establishment provisions inherit the therapeutic product penalty scale. In the United States, 21 U.S.C. 360 is the registration provision for producers of drugs and devices, and its breach is listed among the prohibited acts in section 331.
What to check before you buy
- Ask for the establishment licence number and confirm the activity listed covers importation or distribution of the class of device you are buying.
- Separate the establishment licence from the device licence. The establishment licence belongs to the importer or distributor; the device licence belongs to the manufacturer.
- Where a supplier cites a United States registration number as evidence of Canadian compliance, note that registration and listing are not an approval and are jurisdiction-specific.
- Keep the specification and labelling documentation on file. Section 52 of the Regulations requires the manufacturer, importer and distributor each to maintain distribution records — the paperwork chain in Canada is an explicit legal duty, not an administrative preference.
- For incident handling, remember that section 59 puts the reporting duty on the manufacturer and the importer, which is a reason to know who your importer actually is.
Our position in this comparison is narrow: CliniEco Medical holds MDEL #35334, and we appear in the table only as one of the licensed establishments that import and distribute into Canada. The comparison itself covers both regimes and every supplier equally.
Related reading
- MDEL vs FDA: how device establishment rules differ for clinics — the plain-language buyer's walkthrough of the same two systems
- MDEL, MDL, DIN, NPN: the Canadian regulatory acronym glossary — for reading a supplier's documentation without guessing
- Medical device licensing in Canada: Class I vs Class II vs Class IV explained — the class structure in more depth
- Device licensing vs provincial oversight: sterilizer rules — where federal licensing stops and provincial rules begin
- Dental compliance hub — the index page for the standards and licensing pages cited here
- clinic consumables
- free sterilization log tool
Frequently Asked Questions
Do I need an MDEL to buy gloves or masks for my clinic?
No. In Canada the establishment licence requirement attaches to importing or selling devices, not to buying them. Section 44(2) of the Medical Devices Regulations expressly excludes retailers and health care facilities from the prohibition in section 44(1). What a clinic should verify instead is that the party selling to it holds a licence covering that activity.What is the difference between an establishment licence and a medical device licence?
They are separate instruments with different holders. An establishment licence is issued to a facility for the activities of importing, distributing or selling devices. A medical device licence attaches to a device and is held by its manufacturer, and is required for Class II, III and IV devices under section 26 of the Regulations. A single purchase can involve both, held by different companies.Is an FDA registration number valid evidence of Canadian compliance?
No. United States establishment registration and device listing are made under 21 CFR Part 807 and apply to the American market. Canada's equivalent requirement is the establishment licence under the Medical Devices Regulations. A supplier that holds both has two separate authorisations, and one is not evidence of the other.How does the United States handle a foreign manufacturer selling into the market?
Under 807.40(a) the foreign establishment must register and list its devices, and under 807.40(b) it must submit the name, address and phone number of a single United States agent who resides or maintains a place of business in the United States. Changes to that agent's details must be reported within 10 business days. Under 807.40(c), no device may be imported unless it is listed and was made at a registered foreign establishment.When are the two renewals due?
In Canada, the establishment licence is subject to an annual review filed under section 46.1 of the Medical Devices Regulations. In the United States, annual registration is required for each fiscal year and takes place during the period beginning on October 1 and ending on December 31, as set out in 807.22(b)(1).How much does each authorisation cost?
The Fees in Respect of Drugs and Medical Devices Order sets the fee for examining an establishment licence application or its annual review at $4,590, indexed each April 1 to the April All-items Consumer Price Index. The American annual establishment registration fee for fiscal year 2026 is $11,423, covering October 1, 2025 to September 30, 2026. Because the Canadian amount is indexed annually, confirm the current figure before budgeting.What is the penalty for importing without the required authorisation?
In Canada, contravention of the Medical Devices Regulations is dealt with as an offence relating to a therapeutic product under section 31.2 of the Food and Drugs Act, which carries a fine of up to $5,000,000 on indictment or up to two years imprisonment, or both. Section 31.4 applies where a person knowingly or recklessly causes a serious risk of injury to human health. In the United States, failure to register is a prohibited act under 21 U.S.C. 331(p), and 21 U.S.C. 333(a) sets the exposure at up to one year imprisonment or a fine of up to $1,000, or both, rising to three years or $10,000, or both, after a prior conviction or where the intent was to defraud or mislead.Which class is a sterilizer, and who has to hold what for it?
In Canada, sterilizers fall above Class I, so the device itself requires a manufacturer's medical device licence under section 26, and the establishment importing or distributing it requires an establishment licence under section 44. In the United States the same product needs the applicable premarket pathway and is registered and listed by the establishments handling it. Section 52 of the Regulations also requires the manufacturer, importer and distributor to maintain distribution records for each device.CliniEco Medical holds MDEL #35334. Clinics looking for sterilization monitoring supplies can start with a five-pack trial of CliniEco Biological Indicators, step up to the 24-hour self-contained indicator pack, or compare the full ranges in the sterilization monitoring collection.
Sources
- Medical Devices Regulations, SOR/98-282 (consolidated text)
- Food and Drugs Act, R.S.C., 1985, c. F-27
- Fees in Respect of Drugs and Medical Devices Order, SOR/2019-124
- 21 CFR 807.20 — Who must register and submit a device list
- 21 CFR 807.22 — Times for establishment registration and device listing
- 21 CFR 807.40 — Foreign establishments importing into the United States
- 21 CFR 807.65 — Exemptions for device establishments
- 21 CFR 807.100 — FDA action on a premarket notification
- 21 U.S.C. 331 — Prohibited acts
- 21 U.S.C. 333 — Penalties
- 21 U.S.C. 360 — Registration of producers of drugs or devices
- Medical device user fee amendments: fees
- Who must register, list and pay the fee
- Device registration and listing
- Fees for medical devices: canada.ca
- Frequently asked questions: medical device establishment licensing fees
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