Canadian market entry and compliance
Support for manufacturers, importers and distributors bringing medical devices to the Canadian market: classification, the medical device licence from application to amendment, ISO 13485 and MDSAP readiness, and the establishment licence questions that come with importing and distributing.
Frameworks covered
- Health Canada
- Medical Devices Regulations
- MDSAP
- ISO 13485
What we support
- Classification
- Applying the Canadian classification rules to your device and documenting the rationale, before anything is filed.
- Medical device licence applications
- Preparing Class II, III and IV licence applications and the documents behind them.
- MDL lifecycle
- Amendments for device changes, new models and new manufacturing sites, and keeping licence information current.
- Health Canada correspondence
- Preparing clear, complete responses to screening and review questions, on time.
- ISO 13485 and MDSAP readiness
- Gap assessments, internal audits and mock audits before your MDSAP audit, so the findings come from us first.
- CAPA and supplier qualification
- Fixing the CAPA process and supplier controls that auditors look at closely.
- MDEL consulting support
- For importers, distributors and Class I manufacturers applying for or maintaining their own establishment licence.
- Mock inspections
- A pre-inspection review of your procedures and records, run the way an inspection would be.
- Work in English and French
- Documents, meetings and correspondence in either language.
Situations we help with
- You have a device on sale in the US or EU and want to know what Canada needs.
- You are an importer or distributor and are not sure whether you need an MDEL, or what Health Canada expects of you once you have one.
- Your MDSAP audit is booked and the quality system has not been checked against all participating jurisdictions.
- Health Canada has sent questions on a licence application and the deadline is close.
- A device change is coming and you need to know whether it needs a licence amendment.
Our role
We consult, prepare and review. Your company holds its own licences and signs its own submissions. We do not hold an MDEL, import or distribute devices, or act on your behalf before Health Canada.
Common questions
Do Class I devices need a licence in Canada?
Class I devices do not need a medical device licence. The manufacturer usually needs a medical device establishment licence (MDEL) to import or distribute them, unless an exemption applies, for example selling only through an MDEL holder.
Is MDSAP required for a Canadian medical device licence?
For Class II, III and IV licence applications, Health Canada requires a quality management system certificate issued under the Medical Device Single Audit Program (MDSAP). Class I devices do not need one for licensing.
Can you hold our MDEL or import devices for us?
No. We provide consulting support to companies applying for and maintaining their own MDEL. We do not hold an establishment licence or act as an importer or distributor.
Do you work in French?
Yes. We work in English and French, including documents and correspondence.
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