Guidance on how to complete the application for a new medical device licence or amendment for a private label medical device

Effective date: April 01, 2026

Document change log

Date	Changes
June 1, 2005	General updates
April 1, 2011	General updates
April 1, 2020	Updated to reflect the new Fees in Respect of Drugs and Medical Devices Regulations. The new cost-recovery regulations exempt private label medical devices from review fees associated with licence applications and licence amendment applications.

On this page

• Purpose and scope
• Background
• Definitions
• Timing of applications
• Application forms
• Templates and forms
• Before submitting an application or amendment
• Note about guidance documents in general

Purpose and scope

This guidance describes how to complete an application for a new medical device licence or an amendment for a Class II, III or IV private label medical device.

This guidance applies to applications submitted by private label manufacturers for new device licences and amendments to existing device licences for Class II, III and IV medical devices.

Background

Certain businesses that sell medical devices under their own name or trademark may have limited or no control over the activities covered in the definition of manufacturer. These businesses are most often referred to as private label manufacturers.

Private label manufacturers may not undertake any of the activities outlined in the definition. However, they do fall within this definition since they sell medical devices under their own name and the tasks listed in the definition are being performed on their behalf. For this reason, private label manufacturers and the devices that they market must comply with the requirements of the Medical Devices Regulations.

This guidance is to be used along with the Guidance Document - Private Label Medical Devices. It outlines the conditions under which private label manufacturers can obtain a Class II, III or IV medical device licence, referencing safety, effectiveness and quality systems information held by the original manufacturer or in the possession of Health Canada.

Definitions

Device ID: The device identification number assigned by Health Canada.

Identifier: A unique series of letters or numbers or any combination of these or a bar code that's assigned to a medical device by the manufacturer and identifies and distinguishes it from similar devices. Examples of an identifier for a device are a catalogue, model or part number.

Licence application type: The device can be submitted either as a single device, a system, a test kit, a device group, a device family or a device group family. The term "test kit" applies only to in vitro diagnostic devices. For more information on licence application types, consult Guidance for determining medical device application type.

Manufacturer: A person who:

• sells a medical device under their own name, or under a trademark, design, trade name or other name or mark owned or controlled by them and
• is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, or for assigning to it a purpose, whether those tasks are performed by them or on their behalf

Original manufacturer: The “manufacturer” as defined in the Medical Devices Regulations.

Person: Includes a partnership, firm or association.

Private label manufacturer: A person who sells a private label medical device under their own name or trade mark.

Private label medical device: A medical device that's:

• identical in every respect to a medical device manufactured by an original manufacturer and licensed by Health Canada and
• labelled with the private label manufacturer's name, address and product name and identifier

Regulatory activity (or application): A collection of all regulatory transactions throughout the process of a specific activity.

Regulatory transaction: Filing of any information package sent by a company as part of a regulatory activity such as initial data, unsolicited and solicited data (for example, initial package for a new licence application, response to a clarification request). This does not include company name or address change, manufacturing facility change or transfer of ownership transactions.

Timing of applications

As the private label manufacturer, you may submit an application for a new medical device licence (MDL) for a private label medical device only after an MDL has been issued to the original manufacturer.

To add new identifiers (for example, catalogue numbers) to an existing private medical device licence, you may submit an amendment only after Health Canada has licensed the corresponding identifiers for the original manufacturer's medical device.

Application forms

To apply for a new device licence or medical device licence amendment, you must complete and submit an application through the Regulatory Enrolment Process (REP).

This process facilitates the filing and processing of regulatory information.

REP uses XML files generated by web-based templates instead of PDF forms. Templates and forms are used to capture the necessary information related to company, dossier, transaction and application information.

For information on how to submit through REP, consult Guidance document: Regulatory enrolment process (REP) for medical devices.

Templates and forms

Find information on what you need to include in the following templates and forms.

Company template

The Company Template (CO) ensures that Health Canada has the most up-to-date company and contact information at all times. You must complete the company enrolment process before you submit an application for a medical device licence.

Item 1: Address information

This is the name and address of the company. A complete address must include:

• street name and number or post office box
• city, province or state
• postal or zip code
• country

Item 2: Company representative information

This is the name and contact information for every representative from a respective company that Health Canada may interact with during the lifecycle of a medical device licence, including associated applications or amendments.

A contact listed on this template must include:

• full name and job title of the contact person
• telephone number and email address of the contact person
• preferred language of correspondence

Item 3: Company contact designation

A representative from each company must be designated for the following activities:

• the designated renewal contact is the party that should be contacted or notified annually for licence renewal
• the designated finance contact is the party that should be contacted for any questions or issues about fees

Dossier ID request form

A dossier ID is required in subsequent REP templates to ensure that a regulatory transaction can be filed and transmitted to Health Canada through the Common Electronic Submission Gateway (CESG).

Item 1: Manufacturer company and contact IDs

This refers to the private label manufacturer and contact person who are at the location of the legal "manufacturer" to which the licence will be issued. The corresponding company and contact IDs can be found on the private label manufacturer's final CO XML.

Item 2: Regulatory company and contact IDs

All regulatory correspondence will be sent to this contact (if different from the manufacturer contact ID), but the licence will be issued to the private label manufacturer.

A third party may submit a medical device licence application. To use their assigned company ID and contact IDs, third parties must first enroll their company for a Company Template (CO).

Item 3: Name of the device (as it appears on the label)

The private label device name indicated for a system, medical device family or medical device group family must appear, at least in part, on the label of each member device. Only 1 name is to be entered. The device name on the application form will be used as the licence name unless the application is for a family of medical devices. In this case, a generic licence name that covers all possible trade names (for example, urinary catheters) should be used.

The licence name usually reflects the types of devices that are contained within the licence. The licence name may vary from the device name.

Item 4: Licence application type

A manufacturer may apply for the following types of medical device licences:

• Single medical device: Defined by a unique device name, sold as a distinct packaged entity and does not meet the criteria for a medical device group, medical device family, medical device group family, system or test kit. May be offered in a range of package sizes.
• Medical device family: A group of medical devices made by the same manufacturer that differ only in shape, colour, flavour or size. The devices have the same design and manufacturing process and the same intended use.
• Medical device group: A collection of medical devices, such as a procedure pack or tray, that's sold under a single name.
• Medical device group family: A collection of medical device groups made by the same manufacturer. The devices have the same generic name specifying their intended use and differ only in the number and combination of products that comprise each group.
• System: A medical device with a number of components or parts that are to be used together to fulfill some or all of the device's intended functions. The system is sold under a single name and manufactured by the same manufacturer.
• Test kit: An in vitro diagnostic device that consists of reagents or articles, or any combination of these, and is to be used to conduct a specific test.

For information on how to determine which licence application type is appropriate for your product, consult Guidance for determining medical device application type.

Regulatory transaction template

The regulatory transaction template (RT) collects information on the regulatory activity and transaction (for example, regulatory activity type, transaction description), including the designated regulatory contact for this submission.

Item 1: Regulatory activity type

Choose the appropriate activity type to indicate the nature of the submission (for example, amendment to an existing private label medical device licence).

Activity types not listed are outside of the scope of the REP. You should consult the corresponding guidance for information on how to submit to Health Canada.

Item 2: Invoicing information

All invoicing and billing information will be sent to this contact. This person may be the same as the manufacturer or regulatory contact, or may be a third party. To use their assigned company ID and contact IDs, third parties must first enroll their company for a Company Template (CO).

Item 3: Original manufacturer's company identifier

The corresponding company ID can be found on the original manufacturer's final CO XML.

Item 4: Original manufacturer's licence number

This is the medical device licence number for the medical device manufactured by the original manufacturer.

Application information template

The application information template (AI) collects information about the application and its corresponding devices.

Item 1: Quality management system certificate

Enter the Medical Device Single Audit Program (MDSAP) certificate number and the name of the recognized auditing organization that issued the certificate to the original manufacturer of the device.

Application attestation form

A completed application attestation form must be included with each application. Be sure to select the appropriate application type before you complete the form.

Device details spreadsheet

Include a completed device details spreadsheet with each application that adds, changes or deletes a device from a medical device licence. Device name changes can also be made on this spreadsheet.

Be sure to select the regulatory activities requested in the application on the first sheet of the spreadsheet. Follow the instructions found at the top of each corresponding sheet.

Item 1: Identifier for private label medical device

Only private label devices, components, parts and accessories listed on the application will be considered for licensing. Class I devices and spare parts that do not represent medical devices on their own should not be listed.

Other information

Item 1: Purpose or intended use of device

You must submit a clean copy of the latest version of the instructions for use or package insert that includes the intended purpose, indications for use or conditions for use with the application.

For licence amendments, if there are changes to the instructions for use or package insert, you should submit a red-lined version of the revised pages.

Item 2: Declaration of compliance with the Medical Devices Regulations

An authorized senior official of the private label manufacturer must complete and include the Declaration of Compliance for each device licence application. The template is in Appendix 1.

Item 3: Letter of authorization

A letter signed by an authorized senior official of the original manufacturer must be included in the private label device licence application. The letter must be on the original manufacturer's letterhead and in the correct format. The format is explained in Appendix 2.

Item 4: Refer to the medical device licence application fee form

Follow the instructions provided on the fee form to avoid delays in the processing of your application.

Before submitting an application or amendment

Before you submit a new private label medical device licence application or private label medical device licence amendment application, you must:

• complete the device licence REP application form, fee form and Appendix 1 and 2
  • You may choose to have a regulatory correspondent complete and submit the application on your behalf.
• sign the application attestation form, certifying that all the information in the application is accurate and complete

You or your regulatory correspondent may file the application and any supporting documentation using the Regulatory Enrolment Process (REP).

Submit the application or amendment to Health Canada using the Common Electronic Submission Gateway (CESG).

Appendix 1: Declaration of compliance template

The Declaration of Compliance must be completed by an authorized senior official of the private label manufacturer.

Declaration of Compliance with the Medical Devices Regulations

Name of the private label medical device: (as it appears on the label)

Name of the private label manufacturer:

Address of the private label manufacturer:

I, the private label manufacturer, hereby declare that the medical device named above is a private label medical device, as defined in the Guidance for Industry - Private Label Medical Devices, in that it is identical in every respect to the medical device [name of medical device manufactured by original manufacturer], manufactured by [name of the original manufacturer] and licensed by Health Canada under Licence No. [licence number for medical device manufactured by original manufacturer], except that the medical device named above is labelled with the private label manufacturer's name, address and product name and identifier.

I, the private label manufacturer, hereby declare that procedures have been established and documented and will be maintained for the private label medical device named above to ensure that activities described in sections 57 to 65.1 inclusive of the Medical Devices Regulations regarding complaint handling, mandatory problem reporting and product recalls can be undertaken. These procedures include two-way communication links with the original manufacturer of the identical medical device. I also declare that the private label manufacturer will notify Health Canada of any recalls of the private label medical device named above.

As a senior official of the private label manufacturer, having responsibility for this Declaration of Compliance and the regulatory compliance of the medical device with the requirements of the Medical Devices Regulations, I hereby declare that the information I have provided in support of this application to be accurate and complete.

I, the private label manufacturer, also acknowledge that any false statement made with respect to the procedures in place, or a determination by Health Canada that the procedures are not in place, could result in the suspension of any medical device licence which has been issued for the medical device subject of this Declaration of Compliance.

Name of private label manufacturer's authorized senior official:

Title:

Signature:

Date:

Appendix 2: Letter of authorization template

The private label device licence application must include a letter signed by an authorized senior official of the original manufacturer on the original manufacturer's letterhead in the following format.

(Original manufacturer's letterhead)

Manager, Licensing Services Division
Medical Devices Directorate
Health Products and Food Branch
11 Holland Ave
Address Locator: 3002A
Ottawa ON K1A 0K9

(Date)

Dear Madam or Sir:

RE: (Name of medical device manufactured by original manufacturer)
Licence No. xxxx
Quality Systems (QS) Certificate No. xxxx
Name of QS Registrar:

Please accept this letter as authorization for [name of private label manufacturer] and Health Canada to cross-reference the original medical device licence application and amendment(s) and the supporting safety, effectiveness and quality systems information, held by the original manufacturer or by Health Canada, for [name of medical device manufactured by original manufacturer], licensed by Health Canada under Licence No. [licence number for medical device manufactured by original manufacturer], in support of medical device licence application for [name of private label medical device) to be filed with the Medical Devices Directorate by [name of private label manufacturer]. This authorization is, however, subject to all applicable regulations regarding confidentiality of such information.

I, as a senior official of the original manufacturer, attest that [name of private label medical device] is a private label medical device, as defined in the Guidance for Industry - Private Label Medical Devices, in that it is identical in every respect to the medical device [name of medical device manufactured by original manufacturer] manufactured by [name of original manufacturer] and licensed by Health Canada under Licence No. [licence number for medical device manufactured by original manufacturer], except that the device is labelled with the private label manufacturer's name, address and product name and identifier.

I also agree to provide, upon request from Health Canada, any additional information respecting the safety, effectiveness and quality of the aforementioned private label medical device.

Yours sincerely,

(Signature of authorized senior official)

(Name and title of authorized senior official)

Note about guidance documents in general

Guidance documents provide assistance to industry and health care professionals on how to comply with policies, governing statutes and regulations. They also provide review and compliance guidance to Health Canada staff on how mandates should be implemented fairly, consistently and effectively.

Guidance documents are administrative, not legal, instruments. This means that flexibility can be applied. However, alternate approaches to the principles and practices described in this document must be supported by adequate scientific justification. They should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As always, Health Canada reserves the right to request information or material, or define conditions not specifically described in this guidance, to help us adequately assess the safety, efficacy or quality of a therapeutic product. We are committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable guidances.