Using Overseas Clinical Data
Overview
Most medical devices seeking a Device Licence in Canada will have clinical data generated outside Canada — typically from clinical trials conducted in the US, EU, or other markets where the device received earlier approval. Health Canada generally accepts overseas clinical data, subject to certain conditions.
When overseas data is acceptable
Health Canada accepts clinical data from other jurisdictions when:
- The data is from Good Clinical Practice (GCP)-compliant studies (ICH E6)
- The patient population studied is relevant to the Canadian population
- The device studied is the same as (or substantially equivalent to) the device being licensed in Canada
- The intended use is the same as or narrower than the proposed Canadian intended use
Commonly accepted data sources
| Jurisdiction | Regulatory approval | Data status |
|---|---|---|
| United States | FDA 510(k) or PMA | Typically accepted |
| European Union | CE Mark (MDR/IVDR) | Typically accepted |
| Australia | ARTG inclusion | Typically accepted |
| Japan | PMDA approval | Generally accepted |
| Brazil | ANVISA | Generally accepted |
Health Canada may also accept data from other jurisdictions if the regulatory framework is comparable.
How to present overseas clinical data
In the Device Licence application, overseas clinical data should be presented as:
- Clinical Evidence Summary — synthesising the evidence from all sources
- Study reports — complete study reports for pivotal studies
- Published literature — peer-reviewed publications where study reports are not available
- Regulatory approvals — copies of approval letters/decisions from other jurisdictions (helps establish that the data was previously accepted by a comparable regulator)
Race/ethnicity and population differences
If the primary evidence base comes from populations significantly different from the Canadian population (e.g., studies conducted exclusively in Asian populations for a device intended for a Canadian population with different demographics), Health Canada may ask for additional bridging data or justification that the results are applicable to Canadians.
Data gaps
Where there are gaps in the overseas evidence base (e.g., no data for a specific patient sub-group, or limited long-term data), the application should:
- Acknowledge the gap explicitly
- Explain why the available evidence is still sufficient to conclude the device is safe and effective for the proposed Canadian use
- Propose post-market data collection if appropriate
Legislative source: Medical Devices Regulations, SOR/98-282, Schedule 1; Health Canada guidance on clinical evidence requirements