Canadian regulatory support for international manufacturers
For manufacturers outside Canada, including in Taiwan and India, who want to sell in Canada. We explain what Health Canada expects, prepare the licence application with you, and help you understand the role your Canadian importer or distributor will play.
Frameworks covered
- Health Canada
- MDSAP
- ISO 13485
What entering Canada involves
- Classification under Canadian rules
- Canada has its own four-class system. A device’s class in the US or EU does not carry over automatically.
- An MDSAP certificate
- For Class II to IV devices, Health Canada expects a quality system certificate issued under MDSAP. We assess readiness before the audit.
- The medical device licence
- The manufacturer holds the licence, wherever it is based. We prepare the application and supporting documents with your team.
- Importers and distributors
- Companies importing or distributing your device in Canada need their own establishment licence. We explain what they need from you, and what you need from them.
- Labelling
- Canadian labelling requirements, including when information must appear in English and French.
- Working across time zones
- Work by email and scheduled video calls, with written summaries after each one.
Situations we help with
- You already sell in your home market or in the US and Canada is the next step.
- A Canadian distributor has asked whether your device is licensed.
- Your quality system is certified to ISO 13485 but not yet audited under MDSAP.
Our role
We consult, prepare and review. We do not import or distribute devices, hold licences for clients, or act on your behalf before Health Canada. Your company remains the licence holder.
Start with a market intelligence scan
Before a regulatory engagement, a scan built from public Health Canada, FDA and EU data shows whether comparable devices are already licensed, who holds the licences, and which route is likely. Every report cites its sources, the date the data was pulled, and the coverage limits.
Tell us about your device and the market you are aiming for.
A first conversation covers the device, its likely classification, where you are today and the date you are working to. Every enquiry goes through Crossbridge Partners, so there is one point of contact.
Discuss your regulatory pathway