Benefits of Using a Health Canada Regulatory Correspondent
Legal background
Despite this role, licenses are issued in the name of the manufacturer, who remains the legal license holder. The regulatory correspondent’s primary role is to support compliance and facilitate communication with Health Canada. A knowledgeable regulatory correspondent will ensure that foreign manufacturers will not face missed deadlines and approval delays.
A Canadian regulatory correspondent offers several advantages for manufacturers:
- Ensures that Health Canada inquiries are addressed promptly and accurately
- Provides guidance on Canada-specific regulatory requirements and keeps the manufacturer informed of any changes in regulations.
- Assists with fulfilling ongoing pre- and post-market obligations, such as licensing and renewals
Our services
How Obelis Manages Your Health Canada MDL & MDEL Regulatory Obligations
Obelis will act as your Health Canada regulatory correspondent, handling regulatory procedures and communications.
As your regulatory correspondent, we will:
- Prepare and submit your Medical Device Establishment License (MDEL) and Medical Device License (MDL) applications to Health Canada on your behalf, ensuring all required information is complete and accurate.
- Serve as the primary point of contact for Health Canada, receiving all official correspondence and responding to inquiries or additional information requests during the review process.
- Manage annual license and handle updates or amendments to licenses by communicating changes in products or company details to Health Canada as required.
- Maintains all documentation, records, and copies of licenses on your behalf
FAQ
Frequently Asked Questions
A Health Canada regulatory correspondent is a Canadian-based representative appointed by a foreign manufacturer to manage official communication with Health Canada. They receive all regulatory notices, support compliance with Canadian medical device requirements, and ensure timely responses to licensing or renewal inquiries.
While not always legally mandatory, appointing a regulatory correspondent is strongly recommended for foreign manufacturers submitting MDL or MDEL applications. It ensures that Health Canada receives timely responses from a Canadian point of contact and reduces the risk of delays, compliance issues, or missed renewal deadlines.
A Canadian regulatory correspondent like Obelis Group ensures fast communication with Health Canada, supports pre- and post-market compliance, manages annual license renewals, and provides guidance on Canadian-specific requirements. This helps manufacturers avoid administrative burden, approval delays, and regulatory non-compliance.
Obelis Group acts as your Canadian regulatory correspondent by preparing MDL/MDEL submissions, handling Health Canada communications, maintaining regulatory documentation, managing amendments, and overseeing annual license renewals on your behalf. Our expertise helps ensure compliance throughout the device’s lifecycle.
An MDL (Medical Device License) applies to Class II, III, and IV medical devices and confirms that the device itself is approved for the Canadian market.
An MDEL (Medical Device Establishment License) is required for companies involved in importing, distributing, or selling medical devices in Canada. A regulatory correspondent can help prepare and maintain both licenses efficiently.
