Description
Expanding into the Canadian medical device market requires full compliance with Health Canada’s Medical Devices Regulations (SOR/98-282) and adherence to the licensing framework established by the Therapeutic Products Directorate (TPD) and the Medical Devices Bureau (MDB). Obtaining medical device marketing authorization in Canada involves determining device classification, choosing the correct licensing pathway, and ensuring compliance with the Medical Device Single Audit Program (MDSAP).
SOP-REG-003: Medical Device Marketing Authorization in Canada provides a structured, step-by-step framework for manufacturers, importers, and regulatory professionals navigating the Medical Device Establishment License (MDEL) and Medical Device License (MDL) process. This SOP ensures compliance with ISO 13485:2016 and MDSAP, streamlining the Health Canada approval process for faster market entry.
Why You Need This SOP
Selling medical devices in Canada requires strict adherence to Health Canada’s regulations, including pre-market approval, post-market surveillance, and quality system requirements. Without a clear regulatory strategy, companies risk delays, rejected applications, or compliance penalties. This SOP simplifies the registration process by providing a structured, easy-to-follow guide to:
🔹 Determine the correct licensing pathway based on device classification.
🔹 Prepare and submit applications for an MDL (Medical Device License) or MDEL (Medical Device Establishment License).
🔹 Ensure compliance with MDSAP and ISO 13485 to facilitate approval.
🔹 Accelerate the regulatory review process, avoiding costly delays.
🔹 Meet Health Canada’s post-market compliance requirements, including incident reporting and safety monitoring.
Who Should Buy This SOP?
This SOP is an essential tool for businesses planning to enter or expand in the Canadian medical device market. It is designed for:
✔ Medical Device Manufacturers seeking Health Canada approval.
✔ Regulatory Affairs Professionals managing Health Canada submissions.
✔ Importers & Distributors requiring an MDEL to operate in Canada.
✔ Consultants & Advisors assisting companies with Canadian regulatory compliance.
✔ Startups & SMEs needing a cost-effective, structured approach to licensing.
Why Choose This SOP?
SOP-REG-003: Medical Device Marketing Authorization in Canada is fully compliant with Health Canada’s Medical Devices Regulations (SOR/98-282) and integrates MDSAP best practices for a smoother approval process. This SOP will help you:
✔ Eliminate uncertainty by following a structured, proven method for Health Canada compliance.
✔ Avoid regulatory delays by ensuring complete and accurate submissions.
✔ Ensure full compliance with MDSAP and ISO 13485, reducing audit risks.
✔ Simplify post-market compliance, keeping your license active and avoiding penalties.
✔ Reduce costs by streamlining the licensing process and avoiding resubmissions.
