Canada Medical Device Regulations

We have assembled the following documents as a service to the medical device community. Most documents were published by Health Canada and are in PDF format. Help us keep these files up to date. If you find a newer version of a document or one that should be included, please marketing [at] emergogroup [dot] com (email us).

Links for Medical Device Regulations

Health Canada - Drug and Medical Device Recall Listings

Major Regulations

• Canadian Medical Devices Regulations - SOR 98-282
• Medical Devices Active Licence Listing (MDALL)
• Quality Systems ISO 13485
• Medical Devices Chapter 2 Canadian Requirements
• ISO 13485 Audit Guidelines
• Officially Recognized CMDCAS Registrars

General Guidance Documents

• Health Canada - Guidance on the Content of Quality Management System Audit Reports - GD211
• How to Complete the Application for a New Medical Device Licence
• Information to be Provided by Manufacturers for the Reprocessing and Sterilization of Reusable Medical Devices - DRAFT
• Recognition and Use Of Standards under the Medical Devices Regulations
• Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices
• Medical Device Licence Renewal
• Private Label Medical Devices
• Private Label Medical Devices Questions & Answers
• How to Complete the Application for a New Medical Device Licence/Medical Device Licence Amendment for a Private Label Medical Device
• Licensing Requirements for Inter-dependent Medical Devices - Notice
• Labelling of In Vitro Diagnostic Devices - DRAFT
• The Risk-based Classification System - DRAFT
• The Risk Based Classification System of In Vitro Diagnostic Devices - DRAFT
• Health Canada Licensing Fees - See ANNEX I
• Canadian Establishment Licensing Important: Upcoming Changes

Specific Guidance Documents

• Health Canada - Guide to Recall of Medical Devices - GUI-0054
• Health Canada - Guidance Document for Mandatory Problem Reporting for Medical Devices
• Health Canada - Guidance on Investigation of Reported Medical Device Problems - GUI-0065
• Preparation of an Application for Investigational Testing - Medical Devices
• Preparation of an Application for Investigational Testing - In Vitro Diagnostics Devices

Forms and Applications

• New Class II Medical Device License Application Form
• New Class III Medical Device License Application Form
• New Class IV Medical Device License Application Form
• Application for a New Medical Device Licence for a Private Label Medical Device
• Class II Medical Device License Amendment Application Form
• Class III Medical Device License amendment Application Form
• Class IV Medical Device License Amendment Application Form
• Application for a Medical Device Licence Amendment for a Private Label Medical Device
• Form F201- Change of a Manufacturer's Registration Status
• Form F202- Submission of a New or Modified Quality Management System Certificate
• Mandatory Problem Reporting for Medical Devices Preliminary Report Form
• Medical Device Establishment Licence Application Form and Instructions - Form 0292