Investigational Testing Authorization (ITA)

1. Key takeaways

An Investigational Testing Authorization (ITA) allows an investigational device to be used in a clinical study for the purpose of collecting safety and effectiveness data. The qualified investigator must report serious adverse events to Health Canada, the manufacturer and the importer within 72 hours of becoming aware of them; for events occurring inside Canada, the manufacturer and the importer must additionally submit preliminary and final reports under Sections 59–61. The ITA is a distinct track running parallel to the MDL licensing pathway, and it carries its own reporting clock, its own documentation procedures and its own amendment regime — all of which remain active for the full duration of the study.

• The ITA permits investigational devices to be used in clinical studies to gather safety and effectiveness data.
• The qualified investigator reports serious adverse events within 72 hours to Health Canada, the manufacturer and the importer.
• For events in Canada, the manufacturer and importer file preliminary and final reports (10 days / 30 days) under Sections 59–61.
• Devices for investigational testing involving human subjects are exempt from the device licence and incur no fee.
• Complaint, recall and implant registration card obligations continue to apply during the ITA.

2. Legal basis

The table below lists the sources for the ITA pathway: the reporting obligations in the Health Canada guidance, the relevant sections of the Regulations, and the fee page entry confirming the licence exemption and the absence of fees.

3. Expert insights

Insight 1: An ITA is not a licence, but investigational devices are exempt from ordinary licensing.

Under the Health Canada fee page, a medical device intended for investigational testing involving human subjects is one of the four categories that are exempt from the device licence and therefore attract no fee. The ITA follows an authorisation path that runs parallel to the MDL licensing path. The distinction matters operationally: an authorisation for a defined study, under defined conditions, is not a market authorisation, and the documentation, reporting and amendment obligations attach to the study relationship. Confusing the two tracks leads either to a misplaced MDL application or to an assumption that the ITA confers more commercial latitude than it does.

Insight 2: The 72-hour clock sits on the investigator side and runs in parallel with the company’s 10-day / 30-day clock.

Under the ITA guidance, the qualified investigator’s 72-hour reporting obligation is directed to three parties: Health Canada, the manufacturer and the importer. Separately, for events occurring in Canada, the manufacturer and importer carry their own obligations under Section 60(1)(a): a 10-day report for a death or a serious deterioration in health, and a 30-day report for events that have not done so but might, if they recurred, lead to such outcomes. The two lines are timed separately. The investigator’s notification does not discharge the company’s clock, and the company must run its own timeline from its own awareness of the event.

Insight 3: Post-market obligations are not waived during the ITA.

Under the ITA guidance, the manufacturer and importer must still establish documented procedures for product complaints and recalls under Sections 57 and 58 and Sections 63 to 65, and keep the corresponding records. The implant registration card requirements of Sections 66 to 68 also apply to devices authorised for investigational testing (where applicable, see Schedule 2). In other words, the ITA removes the licensing barrier to the study, not the safety infrastructure around it. A study start-up plan that treats complaint handling, recall readiness and implant registration as post-market work to be configured later has left a gap during the very period when data collection depends on disciplined safety operations.

Insight 4: Amendment requests to the ITA have clearly defined triggers.

Under the ITA guidance, the following may trigger a request to amend the authorisation: changes to the device (design, sterilisation, software, materials, labelling), a change in the device name or identifier, a change in the number of devices applied for, a change in the manufacturer’s name, changes to the study documents (the protocol and the informed consent form), and changes to site information — adding or removing sites, a change of qualified investigator, and updates to research ethics board approval information. The list is broad enough that essentially every meaningful change in the study touches it, which argues for a standing checklist that routes each change through the question of whether an amendment is required.

4. Practical recommendations

• Discuss the clinical protocol with Health Canada during the ITA stage, so the data are not later judged unusable after collection is complete.
• Build the investigator’s 72-hour reporting process and manage it in parallel with the company’s own 10-day / 30-day process.
• Configure complaint handling, recall procedures and implant registration cards (where applicable) in parallel with the ITA itself.
• Establish a checklist for deciding whether a given change requires an amendment of the authorisation, so changes are not implemented without one.
• The investigational device is exempt from the MDL application fee, but MDSAP and other procedural obligations should still be configured according to the actual project.

5. Verification checklist

• □ The ITA pathway has been confirmed and an MDL application has not been filed by mistake
• □ The qualified investigators are aware of the 72-hour reporting obligation and the recipients of the report
• □ The company’s own 10-day / 30-day reporting process is in place
• □ Complaint handling, recall procedures and implant registration cards (where applicable) have been configured
• □ A checklist for deciding whether a change requires an amendment of the authorisation is in place
• □ Research ethics board approval information has been included in change monitoring

Regulatory information verified as of October 28, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Canadian market. Our team manages Health Canada Medical Device Licence and MDEL applications, prepares risk-classified dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com