S&E Checklist & Compliance Matrix

Use this checklist when preparing a Device Licence application to ensure Schedule 1 Safety and Effectiveness Requirements are addressed systematically.

How to use this checklist

For each requirement:

1. Determine whether the requirement applies to your device
2. Identify how compliance is demonstrated (standard, test report, risk analysis, etc.)
3. Reference the specific document in your technical file

Schedule 1 compliance matrix

Requirement	Applicable?	How demonstrated	Key standards
Risk minimisation (benefit-risk balance)	All devices	Risk management file	ISO 14971
Performance over lifetime	All devices	Durability testing, shelf-life data	ISO 11607 (packaging)
Biocompatibility	Devices with patient contact	Biocompatibility evaluation report	ISO 10993 series
Sterility	Sterile devices	Sterilisation validation	ISO 11135 / 11137 / 17665
Electrical safety	Active devices	Electrical safety test report	IEC 60601 series
EMC/EMI	Active devices	EMC test report	IEC 60601-1-2
Software	Devices with software	Software lifecycle documentation	IEC 62304
Usability	All devices	Usability engineering file	IEC 62366-1
Measuring function	Devices with measurement	Accuracy/precision testing	Relevant metrology standards
Radiation protection	Radiation-emitting devices	Radiation safety testing	REDA, applicable standards
Labelling	All devices	Review of label vs. Schedule 1 requirements	MDR s. 21–26
IFU	All devices (where applicable)	Draft IFU reviewed against requirements	MDR s. 21–26

Device-specific requirements

Implantable devices

Additional requirements apply to implantable devices, including:

• Long-term biocompatibility
• Implant card requirements (for certain implantable devices)
• Special labelling (MRI safety information)

See Implantable Devices.

IVDs

IVD devices have specific performance requirements (analytical and clinical performance). See IVD Medical Devices.

SaMD

Software-only devices require particular attention to IEC 62304 documentation and cybersecurity. See Software as a Medical Device.

Including the compliance matrix in your submission

Health Canada expects Device Licence submissions to include either:

• A Safety and Effectiveness Summary that maps claims to evidence for each applicable Schedule 1 requirement, or
• A Standards Attestation for applicable Mandatory Standards, plus supporting test reports or certificates of conformity

tip

Organise your compliance evidence in a Technical File that mirrors the structure of Schedule 1. This makes Health Canada's review more efficient and reduces the likelihood of clarification requests.

Legislative source: Medical Devices Regulations, SOR/98-282, Schedule 1; s 32 (contents of Device Licence application)

For any Schedule 1 requirement marked as 'Not applicable,' provide a brief justification in your Safety and Effectiveness Summary. For example: 'Sterility — Not applicable: device is supplied non-sterile for single use only.' This demonstrates systematic consideration of all requirements rather than oversight.

The tip at the bottom addresses this partially, but should be expanded to its own section: 'Non-applicable requirements — For each Schedule 1 requirement, you must make an explicit determination of applicability. Document your rationale in the Safety and Effectiveness Summary. Examples include: "Sterility — Not applicable: device is supplied non-sterile for single-use only" or "Electrical safety — Not applicable: device is non-electric and contains no electronic components." This demonstrates systematic consideration of all requirements and reduces reviewer clarification requests.'