Guidance on Advance Notice of Importation under section 21.1 of the Medical Devices Regulations (MDR) and section 3.1 of the Radiation Emitting Devices Regulations (REDR)
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From Regulatory Operations and Regions Branch
This document provides guidance to regulated manufacturers and importers wishing to invoke section 21.1 of the Medical Devices Regulations (MDR) and section 3.1 of the Radiation Emitting Devices Regulations (REDR) in order to import medical devices via Advance Notice of Importation.
Medical devices, including those that are also radiation emitting devices, imported for the purposes of these sections are required to have non-compliant device labelling corrected prior to their sale in Canada as well as comply with all provisions of those regulations and the Acts applicable to their devices in order for their sale to be lawful in Canada.
Who this guide is for
- Manufacturers of medical devices
- Importers of medical devices
In this guide
- Background and Scope
- Instructions on applying for Advance Notice of Importation
- Instructions for completing the Form
- Terms and Conditions
- Contact information and References
- Appendix A: Key Definitions and Acronyms
- Appendix B: Medical Devices Regulations and Radiation Emitting Devices Regulations labelling provisions
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Download PDF (600 KB, 18 pages)
Details and history
Part of topic(s): Drug and Health Products - Importation and exportation
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