- Confirmation of device licence can be made by matching the product label to the company information, device name and device identifier found in the MDALL database.
Regardless of whether similar medical devices are listed as Class II, III or IV medical devices, if your medical device is not listed in the MDALL database, then it is not licensed and cannot be imported or sold in Canada.
Class I (low-risk) medical devices do not require a medical device licence ( MDL ) and will not be found on the MDALL website. List all manufacturers, including manufacturers of Class I medical devices.
Step 3: Determine if your activities require an MDEL
For more detailed guidance on who needs an MDEL , see Table 1: MDEL requirement based on activity type of Guidance on medical device establishment licensing (GUI-0016).
Step 4: Register as a small business (if applicable)
Companies looking to apply for the small business fee mitigation must formally register as a small business on Health Canada's website. You must register and receive small business status from the Drug and Medical Device Small Business Application before submitting your MDEL application.
- To register as a small business, you must have a unique identifier.
- To locate or obtain a unique identifier, please see small business mitigation for drugs and medical devices.
For more information on fees and small business mitigation, including a link to the Drug and Medical Device Small Business Application, please see funding and fees.
If your company is not registered as a small business when you file your MDEL application, you will be charged the full fee and will not be considered for the small business fee mitigation.
Step 5: Complete the application form
Section 1 – Application type
Indicate the reason for your application.
- New: applying for your first MDEL or applying for a new MDEL after a cancellation of a previous MDEL .
- Notification: you must submit a notification to Health Canada within 15 calendar days of:
- a change in the name or address of your establishment
- a change in the information of the establishment representative associated with your MDEL application including name, title and contact information
- See section 48 of the Medical Devices Regulations for more details.
If your establishment has had any current or previous MDEL s, please include the current or previous MDEL numbers in this section.
If your establishment has a company ID , please include your company ID in this section. It is a 6-digit number assigned by Health Canada.
If there is any other name under which you previously conducted a licensable activity please include in this section. Include names associated with a merger, if applicable. You do not need to include names associated with acquisitions.
Section 2 – Applicant information
Fill in your establishment information:
- Establishment name is the legal name of the person.
- Person (as defined in section 2 of the Food and Drugs Act and section 1 of the Medical Devices Regulations) – person means an individual or an organization as defined in section 2 of the Criminal Code. It includes a partnership and an association.
- Operating, trade or partnership name(s) are any other company names under the applicant's ownership (same legal entity as the applicant), as applicable.
- Small businesses – certify that you have received confirmation from Health Canada that the small business registration or renewal for your company has been processed and that you hold valid small business status with Health Canada at the time of submitting the application. You may qualify for a reduction in fees if you meet the definition of "small business" as defined in section 1 of the Fees in Respect of Drugs and Medical Devices Order. See the Guidance document – Fees for the Review of Medical Device Establishment Licence Applications for more details.
- Government organizations – indicate if you are a government organization. All applications filed by any branch or agency of the Government of Canada or of a province or territory are exempt from fees. Consult section 3 of the Fees in Respect of Drugs and Medical Devices Order for more details.
- Publicly funded health care institution – indicate if you meet the definition for a publicly funded health care institution. All applications filed by publicly funded health care institutions are exempt from fees. Consult section 3 of the Fees in Respect of Drugs and Medical Devices Order for more details.
2.1 Establishment address
- Establishment licence address is the main physical address. This is the address that will appear on your licence. A.P.O. box will not be accepted as an establishment licence address.
- Business Number ( BN ) is a 9-digit number that is unique to your business and is used when dealing with federal, provincial, or local governments.
2.2 Contact person
- Contact person for the establishment licence is the person Health Canada will contact concerning the MDEL application. For example, Health Canada will send the annual licence review package to the contact person for the establishment licence.
Information required concerning your application is the name, title, email and telephone number of the representative of your establishment Health Canada is to contact. - Email is the main means by which Health Canada communicates with the contact person.
2.3 Mailing address / 2.4 Billing address
- Mailing address – include your mailing address if different from licence address under section 2.1 (establishment address) of the application form and include your mailing address if different from licence address.
- Billing address – include your billing address, and billing contact information if different from address in 2.1 (establishment address) and 2.3 (mailing address).
As per section 48 of the Medical Devices Regulations, an establishment must notify Health Canada if there is a change in the name or address of the establishment or if there is a change in the name, title or contact information of the establishment representative associated with the application.
This must be submitted within 15 calendar days of the change being made by notifying the Medical Devices Establishment Licence Unit at mdel.application.leim@hc-sc.gc.ca.
Section 3 – Activities
Check the box for each activity and class of medical device that applies to your operations. For further information on activities, see Table 1: MDEL requirement based on activity type and Table 2: Licence requirements and exemptions of Guidance on medical device establishment licensing (GUI-0016).
Only an establishment located in Canada can be an importer. The activity of importation includes distribution.
Section 4 – Sites
You must list at least 1 building (including the establishment address) in section 4, where the documented procedures are implemented.
Site(s) – any additional building that is used by the MDEL holder (establishment) where the procedures attested to in paragraphs 45(g) to (i) of the Medical Devices Regulations are in place.
If the documented procedures are implemented at more than 1 building, you must indicate each of these buildings in section 4.
If the site listed is not the same legal entity, then it is the responsibility of the licence holder to ensure that site(s) listed in section 4 of their MDEL application has the applicable procedures in place and that inspectors are able to verify compliance without any impediment.
You may list a building under section 4 (site), including a warehouse, as long as the following conditions are satisfied:
- A.P.O. box is not considered an acceptable site address.
- A site must be in the same country as the establishment.
For example, if the main address for the MDEL (the establishment licence address) is located in Canada, then only sites within Canada can be listed in section 4. If the establishment licence address is located in the U.S , then only sites within the U.S can be listed in section 4.
You may indicate the procedure(s) in place at each site you list. The establishment address is considered a building where procedures attested to are in place unless you indicate otherwise. Health Canada inspectors will verify that you have these procedures in place during an inspection.
Indicate the names of the manufacturers of the medical devices that you import or distribute in section 5. Do not list this information in section 4.
Section 5 – Manufacturer(s) of the devices that are being imported or distributed, and any Supplier(s)
List all manufacturer(s) and any supplier(s) of the medical devices you import or distribute (sell). This section must not be left blank.
- Manufacturer – The name of the manufacturer is on the label of each product.
- Supplier – A supplier is any person, other than the manufacturer, who distributes (sells) a medical device to an MDEL holder for the purpose of import or sale in Canada.
Please read the information below carefully:
- If you are a Class I manufacturer who imports or distributes your own devices: Include your name and address in this section as the manufacturer.
- If you are an importer and/or a distributor of Class I medical devices: Provide the names and full addresses of all the manufacturers of the Class I medical devices you will be importing or distributing (as per the activities indicated in section 3 of the application form).
- If you are an importer and/or a distributor of Class II, III or IV devices: You must search the Medical Devices Active Licences Listing ( MDALL ) database for the manufacturers of all the medical device licences of Class II, III or IV medical devices you import or distribute.
- Visit the MDALL and search for each manufacturer of your Class II, III or IV medical devices. You can search by device identifier (found on the label), product or company name, or company ID .
- Confirm that the manufacturer is licensed for all the classes of devices you will be importing and/or distributing (selling).
- On your application form, enter the name and address listed in MDALL for each manufacturer.
For Class II, III, or IV devices, an establishment shall only sell licensed devices (as per section 26 of the Medical Devices Regulations), unless the medical devices are subject to Part 2 or 3 of the Medical Devices Regulations.
Section 6 – Attestations
A completed section 6 is required for all application types except cancellation requests.
A senior official from your establishment must complete the attestations provided under paragraphs 45(g), 45(h), 45(h.1) and 45(i) of the Medical Devices Regulations, as applicable, based on the activities conducted by your establishment (see section 3 of this application form).
Senior official – The senior official listed on a MDEL application is the person who has direct knowledge of the procedures in place, as confirmed by signing attestations in section 7 on the MDEL application.
Read each statement and check or initial each applicable attestation statement.
False attestations on this application could lead to:
- a refusal of your application under subsection 47(1,) of the Medical Devices Regulations, or
- a suspension of your licence under paragraph 49(1)(b) of the Medical Devices Regulations
Health Canada's Compliance and enforcement policy for health products (POL-0001) and Guidance on medical device compliance and enforcement (GUI-0073) state that the primary responsibility of a regulated party is to understand its obligations under the Food and Drugs Act and its Medical Devices Regulations, and to comply with these requirements. Regulated parties who fail to comply will be subject to compliance and enforcement actions.
Health Canada will inspect your establishment to verify your attestation in section 6 and your establishment's compliance with the Medical Devices Regulations. More information on inspections conducted by Health Canada is found in How Health Canada inspects medical device establishments (GUI-0064).
Section 7 – Signature
A completed section 7 is required for all application types except cancellation requests.
A senior official from your establishment must carefully read, sign and date this section. The application must be signed before it can be reviewed by Health Canada.
Senior official – The senior official listed on a MDEL application is the person who has direct knowledge of the procedures in place, as confirmed by signing attestations in section 7 on the MDEL application.
Manufacturers of Class I to IV medical devices and importers of Class I medical devices have an obligation to report medical device shortages and discontinuations that will lead to a shortage to Health Canada. This is in accordance with section 62.23 of the Medical Devices Regulations.
The name of the senior official associated with an MDEL is published in Health Canada’s medical devices establishment licence listing along with other posted information about establishments.
Conducting activities contrary to any existing Terms and conditions (under section 48.1 of the Medical Devices Regulations) is subject to compliance and enforcement actions.
Appendix A – Cancellation of MDEL
If you choose to cancel your licence for any reason, complete section 1 and Appendix A - Cancellation of MDEL on the MDEL application when all activities under this MDEL have ceased. Once cancelled, you will be notified by email and the MDEL will be inactive.
Only the contact person or senior official for the MDEL may submit a cancellation request to Health Canada.
Health Canada may inspect an establishment that had its MDEL cancelled, to verify that all licensable activities have ceased.
Step 6: MDEL fees
Once Health Canada screens the application and determines that the application is accepted for further review, we will notify you, via email, and include an invoice for the applicable fees.
You must pay a fee for the review/examination of:
- a new application
- a reinstatement application
- an annual licence review application
There are no fees for notifications, amendments or to cancel your licence.
If the fees that are due for an MDEL application have not been paid, Health Canada has the authority to withhold services, approvals, rights and/or privileges.
Should Health Canada use this authority to stop the review of an application, the period of time where services are withheld does not count towards Health Canada's 120 calendar day service standard.
Step 7: Submit your application
Send only 1 application form. Submission of duplicate applications may delay the processing of your application.- Email: mdel.application.leim@hc-sc.gc.ca
If you have made a change to your licence or it is a new application, review the MDEL licence you receive from Health Canada and ensure it is accurate based on the information you submitted. Contact the Medical Devices Establishment Licence Unit at mdel.application.leim@hc-sc.gc.ca if there are any issues.
An existing licence continues to be valid as long as a completed ALR application is received by Health Canada before April 1 of each year.
When will you hear from us?
The performance standard to issue a decision is 120 calendar days from the day a complete application is received. This performance standard applies to the following application types:
- new application
- annual licence review (ALR) application
All MDEL applications will be screened for completeness against the following criteria:
- application file is not corrupt
- application file is not password-protected (we do not accept password-protected PDF documents)
- all sections of the application form are complete and signed
- presence of all indicated documents/emails
- verification/confirmation of changes requested
Once the application is deemed complete, a company identification is assigned and the 120-day clock is started.
Pause-the-clock policy
Health Canada uses a "clock" to measure performance against the 120-calendar day service standard.
- The clock starts on the date when Health Canada receives your complete application.
- In cases where the application requirements listed in the Food and Drugs Act or its Medical Devices Regulations are not met, a deficiency notice is issued to the applicant and the clock is paused.
- When Health Canada has received a response to a deficiency notice, the clock will be resumed.
Health Canada will contact you by email during the licensing process if we have questions or need additional information.
A deficiency is when an application cannot be processed by Health Canada because it does not meet regulatory requirements or the intent/scope of the application is unclear. The applicant is provided an opportunity to submit the missing or incomplete information in order to avoid receiving a negative decision within 30 business days.
In such circumstances, the application clock would be paused for up to 30 business days at a time. If no response is received after the first deficiency notice or if the response that is received is inadequate, a second notice will be issued providing an additional 30 business days to respond.
If no response is received after the second notice is issued to address the same deficiency or if the received response is inadequate, the application will be rejected.
Appendix – Acronyms and references
Acronyms
ALR Annual Licence Review MDALL Medical Devices Active Licence Listing MDEL Medical Device Establishment Licence MDL Medical Device Licence T&Cs Terms and Conditions
References
Laws
- Criminal Code
- Fees in Respect of Drugs and Medical Devices Order
- Food and Drugs Act
- Medical Devices Regulations
Guidance
- Compliance and enforcement policy for health products (POL-0001)
- Medical Device Establishment Licence (MDEL) Terms and Conditions (T&Cs) policy (POL-0156)
- Guidance on medical device establishment licensing (GUI-0016)
- Guide to reporting medical device shortages and discontinuations (GUI-0137)
- Guidance on medical device compliance and enforcement (GUI-0073)
- Guidance on the risk-based classification system for non-in vitro diagnostic devices (non-IVDDs)
- Guidance for the risk-based classification system for in vitro diagnostic devices (IVDDs)
- Guidance document – Fees for the review of medical device establishment licence applications
- How to pay your establishment licence fees
- Performance Standards forthe Fees in Respect of Drugs and Medical Devices Order
Online listing
- Medical Devices Establishment Licence Listing (MDELL)
- Medical Devices Active Licence Listing ( MDALL )
