Complete Application Requirements for New Medical Device Licences – Health Canada Implementation Guidance

Purpose and Legal Context

This implementation guidance assists manufacturers in preparing complete applications for new medical device licences (Class II, III, IV) as required under sections 32–36 of the Medical Devices Regulations. A complete application minimizes screening deficiencies, accelerates the review process, and supports timely market access. The guidance outlines the expected content, organization, and format to meet Health Canada’s review standards. Guidance Document: Complete Application for New Medical Device Licence – Implementation - Canada.ca

Core Components of a Complete Application

1. Administrative Information

• Completed Medical Device Licence Application Form.
• Fee remittance confirmation.
• Manufacturer and establishment licence details.
• Authorized representative information (if applicable).

2. Device Description

• Detailed description of design, materials, components, and accessories.
• Intended use, indications, contraindications, and target population.
• Unique device identifier (UDI) or model/catalogue numbers.
• Comparison table to predicate devices (recommended for substantial equivalence claims).

3. Labelling

• Draft labels for device, package, and accompanying materials.
• Bilingual (English/French) content or justification for single language.
• Compliance with sections 21–23 of the Regulations (warnings, instructions, sterility status, etc.).

4. Quality Management System Evidence

• Declaration of conformity to ISO 13485 or equivalent.
• Scope of certification covering the device.
• Summary of quality system processes relevant to the device.

5. Risk Management

• Risk management file summary per ISO 14971.
• Identification of hazards, risk evaluation, and mitigation measures.
• Residual risk acceptability statement.

6. Supporting Evidence for Safety and Effectiveness

• Class II: Performance testing, bench data, and verification/validation summaries.
• Class III: Additional preclinical data, clinical literature, or limited clinical studies.
• Class IV: Comprehensive clinical evidence, long-term safety data, and benefit-risk analysis.

7. Additional Requirements (as applicable)

• Software documentation (IEC 62304).
• Sterilization validation (if applicable).
• Biocompatibility assessment (ISO 10993).
• Clinical evaluation report or literature review.

Submission Format and Organization

• Use the recommended table of contents and section numbering from the guidance.
• Submit in searchable PDF format with bookmarks.
• Clearly label appendices and supporting documents.
• Provide cross-references between sections and evidence.

Practical Tips to Avoid Deficiencies

• Ensure all mandatory sections are complete and clearly identified.
• Use the screening checklist provided in the guidance to self-assess completeness.
• For amendments, clearly describe the change and provide only relevant updated evidence.
• Engage in pre-submission consultation for novel or high-risk devices.

This guidance supports efficient preparation of complete applications, reducing delays and screening rejections. Detailed checklists, section-by-section requirements, examples of acceptable evidence, and common deficiency patterns are provided in the official Health Canada complete application implementation guidance document. Guidance Document: Complete Application for New Medical Device Licence – Implementation - Canada.ca