Product Establishment in Canada

Product Establishment in Canada

Embarking on the journey of introducing your medical device into the Canadian market?

Our guide simplifies the process, from classifying your device to navigating the licensing requirements. Dive in to ensure your product meets all necessary standards and regulations, setting the stage for a successful entry into the Canadian market.

Step 1: Understanding Your Device: Medical Device Classification

A Guide to Classification: Medical Device Regulations: SOR 98-282

Classification Framework: Four classes (Class I to IV) based on risk, as outlined in Section 6 of the regulations.

Classification Rules: Schedule 1 details the criteria for classifying medical devices, with Part 1 addressing devices other than In Vitro Diagnostics (IVD) and Part 2 focusing on IVDs.

Risk Pyramid

Step 2: Unlocking Market Access: Selecting the Appropriate Medical Device Licence in Canada

Health Canada issues two types of licences for medical devices: the Medical Device Licence (MDL) and the Medical Device Establishment Licence (MDEL). These licences authorise manufacturers, importers, and distributors to bring their medical devices into Canada.

Confused about medical device licences in Canada? No worries! This table breaks it down simply.

Step 3: Implementing ISO 13485 Quality Management System: The Roadmap to Medical Device Single Audit Program (MDSAP) and Canadian Medical Device Market Entry

The Medical Device Single Audit Program (MDSAP) offers a single point of entry for manufacturers of medical devices. With an MDSAP certification from a recognized Auditing Organization (AO), they can satisfy Health Canada's QMS requirements for marketing their products in Canada.

7-Step Roadmap

1. Understand the requirements
2. Building a robust Quality Management System (QMS): Align your QMS with ISO 13485 Standard
3. Prepare for MDSAP Audit
4. Find a MDSAP-Recognised Auditing Organisation (AO), such as BV (Bureau Veritas) or TUV SUD
5. MDSAP Audit outcome
6. Maintain QMS and MDSAP Compliance
7. Obtain the license - MDL/MDEL

Step 4: Obtaining a Medical Device License in Canada: A Step-by-Step Guide

Health Canada issues two key licenses for medical devices: the MDL for Class II, III, and IV devices, and the MDEL for Class I manufacturers and all class importers/distributors. Both ensure compliance with Canadian medical device regulations.

• Guidance document: How to Complete the Application for a New Medical Device Licence/Medical Device Licence Amendment for a Private Label Medical Device
• Documents must be submitted in English or French.

MDL Process Flow:

1. Implement an ISO 13485 compliant QMS eg: ISO 13485 certification
2. ISO 13485:2003 quality system (re)audited by MDSAP
3. Submit the MDL application form
4. Branches by device class:
   • Class II Medical Devices: Declaration of conformity, ISO 13485 (MDSAP) certificate, Labeling documents, Fee payment
   • Class III, IV Medical Devices: Declaration of conformity, ISO 13485 (MDSAP) certificate, Labeling documents, Pre-market review documents, Clinical & non-clinical evidence, Fee payment
5. Review
6. Decision
7. Issued licence will be posted on the Health Canada website

MDEL Process Flow:

1. Complete MDEL application (Form-0292): Applicant information, Activities information, Sites information, Manufacturer, supplier information, and attestations.
2. Submit the MDEL application
3. Fee Payment
4. Review
5. Decision
6. Issued licence will be posted on the Health Canada website

Hitting the Market!

Congratulations! Your medical device has been licensed for your product in Canada, opening doors to a new market. However, this is just the beginning. Unlike some licenses, Canadian medical device approvals don't expire. However, to maintain your access to the market, you'll need to pay annual fees to Health Canada. Remember, neglecting these fees can lead to the revocation of your license.