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January 4, 2026
Approximately 5 minutes
Preparing an Application for Investigational Testing of In Vitro Diagnostic Devices – Health Canada Guidance
Preparing an Application for Investigational Testing of In Vitro Diagnostic Devices – Health Canada Guidance
Purpose and Scope
This guidance document assists manufacturers and sponsors in preparing and submitting an application for an Investigational Testing Authorization (ITA) for in vitro diagnostic (IVD) devices under Part 3 of the Medical Devices Regulations. An ITA is required when IVD devices are to be sold or imported for investigational testing involving human subjects to collect clinical performance data. The document covers when an ITA is needed, application content, review process, and responsibilities during and after testing. Preparation of an Application for Investigational Testing of In Vitro Diagnostic Devices - Canada.ca
When an ITA is Required
An ITA is mandatory for:
- IVD devices not yet licensed in Canada intended for investigational use with human specimens or subjects.
- Licensed IVDs used outside approved labelling or intended use in a way that requires clinical performance data.
- Modifications to licensed IVDs that affect performance and require new data.
Exemptions may apply for certain low-risk activities (e.g., quality control testing without human subjects).
Application Content Requirements
A complete ITA application must include:
- Device Description: Detailed information on the IVD, including intended use, technology, specimen types, and target population.
- Risk Analysis: Identification of risks to subjects, patients, and users, with mitigation measures.
- Study Protocol: Objectives, design, inclusion/exclusion criteria, sample size justification, statistical analysis plan, and performance endpoints.
- Investigator Information: Qualifications, site details, and signed investigator agreements.
- Ethics Documentation: Research Ethics Board (REB) approval or submission evidence.
- Labelling: Investigational use labelling compliant with regulations.
- Quality System Evidence: Manufacturing and quality controls information.
- Administrative Forms: Application form, fee payment, and sponsor declarations.
Review Process and Timelines
- Health Canada reviews applications for completeness within 7 calendar days.
- Full scientific and ethical review typically takes 30–60 calendar days, depending on complexity.
- Additional information requests may extend timelines.
- Authorization is granted if the benefits outweigh risks and the study is scientifically sound.
Post-Authorization Obligations
- Notify Health Canada of any changes affecting safety, performance, or study validity.
- Report serious adverse events and unanticipated problems promptly.
- Submit progress reports as required.
- Ensure ongoing REB oversight and informed consent.
- Maintain detailed records for potential audits.
Practical Recommendations
- Engage early with Health Canada via pre-submission meetings for complex studies.
- Align protocol with recognized standards (e.g., CLSI, ISO 20916).
- Ensure robust risk management per ISO 14971.
- Coordinate REB and Health Canada timelines to avoid delays.
This guidance supports safe and ethical investigational testing of IVD devices while facilitating generation of reliable clinical performance data. Detailed checklists, templates, timelines, and contact information are provided in the official Health Canada document. Preparation of an Application for Investigational Testing of In Vitro Diagnostic Devices - Canada.ca
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