Device Description & Specification

Purpose

The device description and specification section of a Device Licence application provides Health Canada with a clear technical understanding of what the device is, how it works, and what it is intended to do. A well-written device description reduces clarification requests and expedites review.

Device name and identification

Element	Requirements
Device name	The name under which the device will be sold in Canada
Model/catalogue numbers	All models, catalogue numbers, and sizes included in the application
Device family	Identification of the device family, if applicable
Accessories and components	List of accessories and components sold with or separately from the device

Intended use and indications

The intended use statement is one of the most important elements in the submission. It must:

• Clearly describe the medical condition, disease, or anatomy the device addresses
• Specify the patient population (age, sex, weight, clinical condition)
• State the intended users (e.g., trained surgeon, nurse, lay user)
• Describe the clinical setting (hospital, home, ambulatory)
• State the duration of use where relevant

Health Canada uses the intended use statement to confirm the device's classification and to scope the evidence review.

Device description

The technical description must cover:

Physical description

• Dimensions, weight, and form factor
• Materials of construction (especially for patient-contact surfaces)
• Components and sub-assemblies
• Method of sterilisation (if supplied sterile)

Principles of operation

• How the device achieves its intended therapeutic or diagnostic effect
• Energy sources (if active device)
• Software architecture (if device contains software)
• Relevant technical specifications (output parameters, accuracy, resolution)

Device variants

Where a single application covers a family of devices, the submission must:

• Identify the "worst-case" device(s) for each applicable safety parameter
• Justify the family grouping (typically: same intended use, same design principles, same materials, same manufacturing process)

Comparison to predicate devices

For Class II devices, applicants may reference substantially equivalent predicate devices already licensed in Canada to support the safety and effectiveness case. Where a predicate is used:

• Identify the predicate device (name, manufacturer, Device Licence number)
• Describe similarities and differences
• Address how differences do not adversely affect safety or effectiveness

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