Guidance on how to complete the application for a new medical device licence: Guidance for implementation

On this page

• When a new medical device licence is required
• Applying for a medical device licence
• Before submitting a medical device licence application

When a new medical device licence is required

Under the Medical Devices Regulations, a new device licence is a pre-market requirement for:

• any new device that was imported or sold in Canada after July 1, 1998
• a licensed device whose licence type is being modified from the type in the original licence application (see the guidance for interpreting sections 28 to 31: licence application type)
• a device previously authorized for sale for investigational testing, or under the special access provisions of the Regulations, that is now to be offered for general sale

Applying for a medical device licence

Device classification

The rules to classify medical devices are outlined in Schedule 1 (Parts 1 and 2) of the Regulations. Part 1 of Schedule 1 addresses medical devices other than in vitro diagnostics. Part 2 addresses in vitro diagnostic devices.

For further guidance on the classification of medical devices, see the:

• guidance on the risk-based classification system for non-in vitro diagnostic devices or
• guidance for the risk-based classification system of in vitro diagnostic devices

After ascertaining the class of the device, use the appropriate application form:

• New Class II Medical Device Licence Application Form
• New Class III Medical Device Licence Application Form
• New Class IV Medical Device Licence Application Form

The keyword index to assist manufacturers in verifying the class of medical devices is an alphabetical listing of all the short descriptors for devices that are entered into the medical devices system. This document contains synonyms and industry words that are used to describe these devices, along with their respective classifications.

Item 1: Name of the device (as it appears on the label)

The 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 one name is to be entered in Item 1. 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 and sometimes may vary from the device name.

Item 2: Manufacturer information (as it appears on the label)

This is the name and address of the manufacturer of the device and the name and address to which the licence will be issued. A complete address must include:

• name and title of a contact person (contact person at the location of the legal "manufacturer")
• company ID (if known, this number is assigned by Health Canada)
• telephone number, fax number and email address of the contact person
• street name and number or post office box
• city, province or state
• postal or zip code
• country

Item 3: Regulatory correspondent information

All regulatory correspondence will be sent to this address (if different from Item 2), but the licence will be issued to the manufacturer. A third party may submit a medical device licence application. The mailing address and name of this authorized regulatory correspondent will be entered here.

Item 4: Invoicing information

Enter the name, address and contact information of the party that will receive all invoicing and billing information. This person may be the same as in Items 2 or 3, or it may be a third party.

Item 5: Quality management system certificate

Enter the certificate number and the name of the recognized registrar that has issued the certificate. A legible copy of the certificate must accompany each medical device licence application. For more information on the content and acceptance of quality management system certificates, please see the guidance on the content of ISO 13485 quality management system certificates issued by Health Canada recognized registrars (GD207). The certificate must be issued by a Health Canada-recognized registrar. Please see the current list of recognized registrars.

Item 6: Attestations

Class II licence applications

Attestation of compliance with the applicable requirements of sections 10 to 20

Manufacturers of Class II medical devices must attest that they have objective evidence establishing that they are compliant with section 10, subsections 11(1) and 12(1) and sections 13 to 20 of the Regulations.

For decorative contact lenses, manufacturers must attest that they have objective evidence establishing that they meet section 10, subsections 11(2) and 12(2) and sections 13 to 17 of the Regulations.

Attestation of investigational testing for in vitro diagnostic devices (IVDDs)

Manufacturers of Class II near patient IVDDs must attest that investigational testing of their device was conducted:

• using human subjects representative of the intended patients and
• under conditions similar to the intended conditions of use of the device

Near patient attestation

Manufacturers must attest that the device is not a near patient IVDD, if applicable.

Signature

The manufacturer of the device must sign and date the application.

Class III and IV licence applications

Attestation section

Along with the application form, a manufacturer must attest that the information requested in section 32, subsection (3) or (4) of the Regulations is complete. Please refer also to the:

• guidance on supporting evidence to be provided for new and amended licence applications for Class III and Class IV medical devices, not including in vitro diagnostic devices (IVDDs)
• draft Health Canada IMDRF table of contents for medical devices applications guidance

Signature

The manufacturer of the device must sign and date the application.

Item 7: Purpose or intended use of device

Information in this item is crucial to establishing the appropriate device class. It should include the following:

• intended purpose, indications for use, conditions for which the device is used
  • the intended use statement should be verbatim as it appears on the device labelling
• patient population for which the device is intended, including age range, if applicable, and specific diagnoses
• anatomical and physiological particulars related to the patient using the device, if applicable
• whether the device uses an energy source and whether energy is transferred to the patient
• the document, document version number and date where the formal intended use appears

For licence amendments, if there are changes to the instructions for use/package insert, a red-lined version of the revised pages should be submitted. A clean copy of the latest version of the IFU/PI should also be submitted with the application.

Item 8: Licence application type

A manufacturer may apply for the following types of device licence:

• Single medical device: Defined by a unique device name, sold as a distinctly packaged entity and does not meet the criteria for a medical device group, medical device family, medical device group family, system or test kit, and may be offered in a range of package sizes
  • examples include an acupuncture needle, aneurysm clip, larynx prosthesis or dental cement
• Medical device family: A group of medical devices made by the same manufacturer that differ only in shape, colour, flavour or size, have the same design and manufacturing process and have the same intended use
  • examples include intra vascular catheters, insulin syringes, feeding tubes or vascular access grafts
• Medical device group: A collection of medical devices, such as a procedure pack or tray, that is sold under a single name
  • examples include a denture repair kit, de-clotting tray, parenteral administration kit or disposable circumcision tray
• Medical device group family: A collection of medical device groups that are made by the same manufacturer, have the same generic name specifying their intended use and differ only in the number and combination of products that comprise each group
  • examples include intravenous (IV) administration sets, dressing trays, contact lens care kits or irrigation trays
• System: A medical device comprising a number of components or parts intended to be used together to fulfil some or all of the device's intended functions, and that is sold under a single name and manufactured by the same manufacturer
  • examples include hip prostheses, knee prostheses or ultrasonic imaging system
• Test kit: An in vitro diagnostic device that consists of reagents or articles, or any combination of these, and is intended to be used to conduct a specific test

For further assistance in ascertaining the appropriate licence application type for your product, please see the guidance for interpreting sections 28 to 31: licence application type.

Item 9: Place of use

Indicate on the application form by checking the appropriate boxes.

Item 10: Medical devices containing drugs

Non-IVD devices containing drugs

Do not complete Item 10 if the device is an IVDD.

If the device contains a drug or drug substance, which includes a pharmaceutical or biological drug, or a natural health product, specify its:

• brand or trade name
• active ingredient(s)
• manufacturer
• drug identification number (DIN) or natural product number (NPN)

Health Canada's Drug/Medical Device Combination Products Policy addresses the regulation of products that contain both a drug and medical device.

IVDD test kits containing controlled substances

If the device is a test kit containing a substance listed in Schedule I, II, III or IV of the Controlled Drugs and Substances Act, it would need to be registered with the Office of Controlled Substances.

For information on the process for applying for a test kit registration number, please see the Office of Controlled Substances.

Item 11: Device history

Indicate if the device has been previously authorized for sale in Canada under the investigational testing or special access provisions of the Regulations. A device that has been previously authorized for sale under the investigational testing provisions will have a device identification (ID) number. A device that has been previously authorized for sale under the special access provisions will have an authorization number. Please supply the appropriate number.

Item 12: Identifier of device

Only devices, components, parts and accessories listed on the application will be considered for licensing. Spare parts that do not represent medical devices on their own should not be listed. If additional space is required, photocopy the Item 12 page and attach it to the application form.

For a single device:

• Enter the name of the device in the first column.
• Enter the identifier for the device (bar code, catalogue, model or part number) in the second column.
• Check the third column if the device contains ≥0.1% by mass of DEHP.
• Check the fourth column if the device is manufactured from raw materials containing or derived from BPA.

For a medical device group, medical device family or medical device group family:

• List the names of the constituent members in the first column.
• Enter the associated identifiers in the second column.
• Check the associated row in the third column if a constituent member contains ≥0.1% by mass of DEHP.
• Check the associated row in the fourth column if a constituent member is manufactured from raw materials containing or derived from BPA.

Please refer to Health Canada's policy statement on the working definition for nanomaterial.

The working definition indicates that a nanomaterial is a material within 1 to 100 nanometers in at least one dimension. However, for the purposes of medical device licensing, the Medical Devices Directorate is requesting notification for devices containing nano-scale materials with a particle size between 1 and 1,000 nanometers.

Please identify the specific type of nano-scale material that is present in each device listed in the licence application. Examples of a specific type of nano-scale material could include:

• nano titanium dioxide
• nano silver
• quantum dots
• nano polymers
• nano glasses
• nano ceramics
• carbon nanotubes
• nano-fibres

The last column in the application is for Health Canada use only.

See the definitions of "BPA," "DEHP" and "identifier" in this guidance document.

It is the manufacturer's responsibility to determine whether a medical device contains ≥0.1% w/w of DEHP or is manufactured from raw materials containing or derived from BPA.

The absence of a checkmark in the third and fourth columns for a specific device will be taken to indicate the device:

• does not contain ≥0.1% w/w of DEHP or
• is not manufactured from raw materials containing or derived from BPA

Item 13: Compatibility of interdependent devices

For a device intended to be used with another Class II, III, or IV device, a list of all medical devices that this device is intended to be used or function with is required. Include their licence number as well. This requirement is intended to be for system components from the same manufacturer.

An important requirement in demonstrating compliance with the applicable requirements of sections 10 to 20 of all medical devices intended to be used together is compliance with section 18 of the Regulations. Section 18 requires that when medical devices are intended to be used with other medical devices, they must:

• be compatible with every other medical device with which they interact and
• not adversely affect the performance of the combination of medical devices

Failure to submit compatibility information for interdependent medical devices may lead to delays in the pre-market review of device licence applications. The Medical Devices Directorate will need to request the necessary information. Manufacturers will also need to assemble the device and submit it for review.

Manufacturers are reminded that the submission of evidence of compatibility for inter-dependent medical devices is a requirement under the Regulations.

See also the notice to industry, dated April 30, 2002, on the licensing requirements of interdependent medical devices.

Item 14: List of recognized standards complied with in the manufacture of the device

Refer to the guidance on the recognition and use of standards under the Regulations.

For Class II licence applications, the manufacturer is to list the recognized standards complied with. Alternatively, the manufacturer is to attest that they possess objective evidence that the device either:

• meets an equivalent or better standard or
• has been tested and alternate evidence of compliance with the applicable requirements of sections 10 to 20 exists

For Class III and IV licence applications, the manufacturer must respond "YES" where applicable and provide appropriate documentation:

• if the device conforms with recognized standards, the manufacturer may provide a "declaration of conformity form" indicating the standard(s) or submit detailed information as evidence of compliance
• if the device does not conform with the listed recognized standards, but meets an equivalent or better standard, the manufacturer may provide a "declaration of conformity form" to indicate these equivalent or better standards
• if the device does not conform with the listed recognized standards or does not meet an equivalent or better standard, the manufacturer is to include detailed information as evidence of compliance with the applicable requirements of sections 10 to 20

If the manufacturer does not comply with any of these 3 options, a licence will not be issued.

Item 15: Priority review

Manufacturers may complete this item if they wish to request a priority review for their application. Priority review will be granted to a Class III or IV medical device licence application intended for the diagnosis or treatment of a serious, life-threatening or severely debilitating disease or condition. There must be substantial clinical evidence that the medical device:

• provides effective treatment or diagnosis of a disease or condition for which no medical device is currently licensed in Canada
• provides significant risk-benefit improvement over existing therapeutic or diagnostic devices for a disease or condition that is not adequately managed by existing products marketed in Canada or
• responds to an unforeseen or unmet urgent health need (new)

Priority review can be considered where any of the above criteria apply, especially for treating the following:

• rare or higher-risk diseases (for example, diabetes, heart disease, cancer)
• vulnerable patient populations (for example, children and young people, people with disabilities or people affected by mental illness)

Health Canada encourages manufacturers to include sex and gender-based analysis where applicable when requesting a priority review.

Applications requesting priority review will be screened in accordance with the standard 15-day performance target. They will be reviewed in priority if they meet one of the above criteria. Depending on the complexity of the application or the novelty of the product, this might lead to a shorter time to market.

The current fees and service standards for reviewing Class III and IV licence applications will still apply (60 and 75 days). Applicants will be notified at screening acceptance whether their application was accepted for priority review.

Class II licence applications

Item 16: Review documents

Indicate which review documents listed in the table in the application form are included as attachments to the application.

For details on the content and format of labelling material for Class II medical devices, refer to the:

• guidance for labelling medical devices
• guidance for labelling in vitro diagnostic devices

For high-level disinfectant or sterilant solutions and/or contact lens disinfectants, manufacturers must provide either:

• an existing DIN for a marketed product or
• objective evidence to establish that this device meets section 10, subsections 11(1) and 12(1) and sections 13 to 20 of the Regulations

For details on the safety and effectiveness information required of high-level disinfectants and sterilants, please see the:

• guidance document on the safety and effectiveness requirements for high-level disinfectants and sterilants for use on reusable semi-critical and critical medical devices

For details on the safety and effectiveness information required of contact lens disinfectants, please see the:

• guidance document on the safety and effectiveness requirements for contact lens disinfectants

Item 17: Refer to the medical devices licence application fee form

Instructions are provided on the form. They must be carefully followed to avoid delays in application processing.

Please see the:

• guidance document on fees for the review of medical device licence applications

Class III licence applications

Item 16: Review documents

Indicate which review documents listed in the table in the application form are included as attachments to the application.

For details on the content and format of review documents for Class III and IV medical devices, please see the:

• guidance on supporting evidence to be provided for new and amended licence applications for Class III and Class IV medical devices, not including in vitro diagnostic devices (IVDDs)
• draft Health Canada IMDRF table of contents for medical devices applications guidance

Items 17: Refer to the medical device licence application fee form

Instructions are provided on the form. They must be carefully followed to avoid delays in the processing of your application.

Please also see the:

• guidance document on fees for reviewing medical device applications

Class IV licence applications

Item 16: Review documents

Indicate which review documents listed in the table in the application form are included as attachments to your application.

For details on the content and format of review documents, please see the:

• guidance on supporting evidence to be provided for new and amended licence applications for Class III and Class IV medical devices, not including in vitro diagnostic devices (IVDDs)
• draft Health Canada IMDRF table of contents for medical devices applications guidance

Item 17: Devices containing biological material

This section of the application form must be completed in detail. If more space is required, photocopy the page and attach it to the application form.

Items 18: Refer to the medical device licence application fee form

Instructions are provided on the form. They must be carefully followed to avoid delays in the processing of your application.

Please also see the:

• guidance document on fees for reviewing medical device applications

Before submitting a medical device licence application

Before submitting a new medical device licence application, make sure you:

1. Complete the device licence application form and fee form. You may choose to have a regulatory correspondent complete and submit the application on your behalf.
2. Sign the application form, certifying that all the information in the application is accurate and complete. A faxed copy of the manufacturer's signature or an e-signature is acceptable.
3. Submit the applicable licence fee for a Class II, III or IV medical device with the application when applicable or upon receipt of an invoice. For further information on timing, please see the guidance document on fees for the review of medical device licence applications.
4. Submit the quality management system certificate with the application.
5. Submit the licence application disclosure request with the application.

You or your regulatory correspondent may submit the application and any supporting documentation to:

Bureau of Licensing Services
Medical Devices Directorate
Health Canada
11 Holland Avenue
Address Locator 3002A
Ottawa ON K1A 0K9

Phone: 613-957-7285
Fax: 613-957-6345
Email: devicelicensing-homologationinstruments@hc-sc.gc.ca