Frequently Asked Questions
Common questions about navigating Health Canada compliance for medical devices.
We assist with all classes of medical devices (Class I through IV) seeking approval for the Canadian market through Health Canada.
Timelines vary by device class and complexity. We work closely with you to streamline the process and minimize delays.
Yes, foreign manufacturers require a Canadian Medical Device Licence holder. We can guide you through this requirement.
An MDL is required by Health Canada for all medical devices sold in Canada. It confirms your device meets Canadian safety and effectiveness standards.
Yes, we provide ongoing support including adverse event reporting, licence amendments, and regulatory updates.
With over 100 applications filed and 40+ clients served, we offer a direct boutique service — no layers of management between you and your consultant.