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)