Canada Medical Device Regulations

Most documents listed below were published by Health Canada and are in PDF format. Please help us maintain this list by reporting outdated or missing documents to marketing [at] emergogroup [dot] com. If you need help determining the regulatory requirements for your medical device in Canada , you may be interested in our custom regulatory strategy reports for Canada .

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 Guidance on Transition to IEC 60601, 3rd Ed
• 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