FDA LISTING INC: EXPERIENCED ADVISORS FOR FULL-SERVICE FDA REGISTRATION & COMPLIANCE
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U.S. FDA Registration
& Labeling Compliance Assistance
Health Canada Compliance Services
Manufacturers, importers, distributors, and other businesses entering or operating in the Canadian market must meet specific Health Canada regulatory requirements. Requirements vary by product classification and the business’s activities. Medical devices, over-the-counter (OTC) drugs, and cosmetics each follow different licensing, authorization, and notification requirements.
Before submitting an application or notification, businesses should establish the appropriate regulatory pathway, identify who is responsible for the submission, and understand ongoing maintenance requirements. This initial assessment helps distinguish establishment-level requirements from product-level requirements and determines whether multiple regulatory obligations apply.
Medical Device Establishment License (MDEL)
A Medical Device Establishment License (MDEL) authorizes qualifying businesses to import or distribute medical devices in Canada. An MDEL applies to the establishment and its regulated activities, not to an individual device. Canadian importers and distributors generally require an MDEL unless an exemption applies.
Certain Class I medical device manufacturers may also require an MDEL, depending on their activities and applicable exemptions. Foreign businesses may hold an MDEL for qualifying activities; however, only establishments physically located in Canada can list importation as a licensed activity.
MDEL Application Process & Annual Review
Applicants identify their business activities, device classes, locations, manufacturers, suppliers, and regulatory contacts. A senior official must complete the required attestations. The process includes submitting the application, Health Canada screening, paying the fee, review, and a licensing decision.
Health Canada may request additional information during the review. Existing license holders must maintain their MDEL by completing an Annual License Review (ALR) before April 1 each year. For the 2026–2027 fiscal year ending March 31, 2027, Health Canada’s published MDEL application and annual review fee is CAD 5,519, with fees subject to annual adjustment.
FDA Listing Inc. reviews proposed device classes and business activities to assess MDEL applicability, prepares new MDEL applications or ALR submissions, and assists with Health Canada communications. The license holder remains responsible for its required procedures and senior-official attestations. Contact us to discuss a new MDEL, annual review, or license change.
Medical Device License (MDL)
A Medical Device License (MDL) authorizes the sale of a Class II, III, or IV medical device in Canada. The manufacturer holds the product license. Class I devices do not require an MDL, although businesses involved in the supply chain may have separate MDEL requirements. Manufacturers must confirm the device classification, select the appropriate application type, and prepare the documentation required for the applicable class, including relevant safety and performance information.
Class II, III, and IV medical device manufacturers must hold a valid ISO 13485 certificate under the Medical Device Single Audit Program (MDSAP). The manufacturer submits the application and responds to Health Canada questions before Health Canada issues a licensing decision. An authorized regulatory correspondent may manage the application on the manufacturer’s behalf without becoming the license holder.
MDL Annual Maintenance & Fees
Class II, III, and IV license holders must complete an annual license-renewal notification and pay the applicable annual right-to-sell fee. Health Canada also charges application-review fees based on the device class and submission type. For 2026–2027, Health Canada’s published annual right-to-sell fee is CAD 460. These obligations are separate from the MDEL Annual License Review.
FDA Listing Inc. evaluates device classification, the proposed application pathway, MDSAP documentation, and available technical records; assists with MDL applications; and supports Health Canada communications. Class III and IV submissions are assessed individually because they may require more extensive technical documentation. Contact us to discuss your device and available documentation.
OTC Drug Identification Number (DIN)
A Drug Identification Number (DIN) identifies an OTC drug that Health Canada has authorized for sale in Canada. Manufacturers must obtain the appropriate market authorization before selling the product. A DIN authorizes the product but does not replace a Drug Establishment License (DEL), which is required for activities such as manufacturing, packaging, labeling, testing, or importing.
DIN Application Requirements & Process
Manufacturers first confirm that Health Canada classifies the product as a non-prescription drug and determine the appropriate application pathway. Eligible products may qualify for a Drug Identification Number Application (DINA), including a Category IV Monograph application (DINF).
Products requiring review as new drugs follow a more extensive submission pathway. The applicant prepares the formulation, proposed uses and claims, directions, warnings, labels, and other information required for the selected application route. After submission, Health Canada may request clarification or revisions before issuing a decision.
DIN Annual Maintenance & Fees
Health Canada charges an application-review fee based on submission type and classification; no single fee applies to all OTC DIN applications. For the 2026–2027 fiscal year, Health Canada’s published annual right-to-sell fee for a non-prescription drug is CAD 3,391. Manufacturers must also complete the applicable annual drug notification and report relevant changes to the product or its market status.
FDA Listing Inc. can review the formulation, claims, and proposed labels; assess the likely application pathway and monograph fit; prepare selected DIN applications; and assist with Health Canada inquiries. We assess products requiring a new drug submission individually because they involve more extensive regulatory review. Contact us to discuss your OTC product and available documentation.
Health Canada Cosmetic Notification (CNF)
Manufacturers and importers must notify Health Canada within 10 days after first selling a cosmetic in Canada. The Cosmetic Notification Form (CNF) provides Health Canada with the required product and business information. A cosmetic notification is not a product license or Health Canada approval. The manufacturer and importer remain responsible for the product’s safety and regulatory compliance.
Cosmetic Notification Requirements & Process
The manufacturer and importer should first confirm that Health Canada classifies the product as a cosmetic, not a drug or another regulated product. They then gather the product’s intended function, ingredients and concentrations, manufacturer and importer information, and required contact details. The responsible business submits the CNF within 10 days after first sale and responds to any Health Canada questions. The notification requires a Canadian address for the manufacturer or importer. A consultant may assist with the notification but does not replace the manufacturer’s or importer’s regulatory responsibilities.
Cosmetic Notification Updates & Fees
The manufacturer and importer must update the notification when relevant product or business information changes and notify Health Canada when the product is discontinued. Health Canada does not charge a government fee for submitting a CNF and does not require an annual cosmetic-notification renewal.
FDA Listing Inc. can review the proposed product classification, ingredients, and label information; prepare new or revised cosmetic notifications; and assist with Health Canada inquiries. The manufacturer or importer remains responsible for the product and the accuracy of the information provided. Contact us to discuss a new cosmetic notification or an update to an existing one.
Frequently Asked Questions (FAQ)
Does every medical device need a Health Canada medical device license?
No. Class II, III, and IV medical devices generally require a Medical Device License (MDL) before they can be sold in Canada. Class I devices do not require an MDL, but manufacturers, importers, and distributors may need a Medical Device Establishment License (MDEL), depending on their activities and any applicable exemptions.
What is the difference between an MDL and an MDEL?
An MDL applies to a specific Class II, III, or IV medical device and is issued to the device manufacturer. An MDEL applies to a business’s activities, such as importing or distributing medical devices. Depending on the device classification and the company’s role, both licenses may be relevant.
Does a natural health product need a license before sale in Canada?
Yes. Natural health products generally require a product license before they can be sold in Canada. Licensed products receive a Natural Product Number (NPN) or, for eligible homeopathic medicines, a DIN-HM. Businesses that manufacture, package, label, or import natural health products in Canada may also require a site license for those activities.
Is a Canadian cosmetic notification the same as product approval?
No. Health Canada does not approve cosmetics before they are sold through the cosmetic notification process. Manufacturers and importers must submit a Cosmetic Notification Form within 10 days after first selling the cosmetic in Canada, and the product must comply with applicable Canadian requirements.
Can an existing U.S. label be used for a product sold in Canada?
Not necessarily. Canadian labeling requirements depend on whether the product is classified as a medical device, natural health product, or cosmetic. Review the label against the applicable Canadian requirements before marketing the product in Canada.
Can FDA Listing Inc. help if we already have a Canadian importer or other local partner?
Yes. We can review product and business information, identify documentation gaps, prepare application or notification data, and support the agreed submission process. The scope depends on the product category and the existing Canadian party’s responsibilities.
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