Declaration of Conformity

What is a declaration of conformity?

A declaration of conformity (DoC) is a formal statement by the manufacturer that their device meets specified requirements. In the context of a Health Canada Device Licence application, the DoC attests that the device meets the Safety and Effectiveness Requirements of Schedule 1 and any applicable standards.

Is a DoC required?

Health Canada requires a declaration of conformity as part of Device Licence applications. The exact form and content requirements are specified in Health Canada's guidance documents for device licence applications.

Differences from EU DoC

The Canadian declaration of conformity differs from the EU Declaration of Conformity (required for CE marking):

Feature	Canada	EU
Who issues	Manufacturer	Manufacturer
Signed by	Authorised senior officer	Authorised person
References	Schedule 1 S&E Requirements + applicable standards	MDR/IVDR Article 19 + Annex I GSPR + applicable standards
Published publicly?	Not typically	Yes — must be publicly accessible
Required for?	Device Licence application	CE marking

What the Canadian DoC should include

A Canadian declaration of conformity for a Device Licence application typically includes:

1. Manufacturer name and address
2. Device name, model numbers, catalogue numbers
3. Statement that the device meets Schedule 1 Safety and Effectiveness Requirements
4. List of applicable standards complied with (including Mandatory Standards attestation)
5. Reference to the technical documentation supporting the declaration
6. Name and signature of the authorised senior officer
7. Date

Keeping the DoC current

The declaration of conformity must remain current. If the device is modified in a way that affects its safety or effectiveness, or if new versions of applicable standards are adopted, the DoC must be updated and may trigger a Device Licence amendment.

Legislative source: Medical Devices Regulations, SOR/98-282, s 32; Health Canada Guidance on Device Licence Applications