Canadian Medical Device Regulations (CMDR)

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 email us.

Health Canada Regulatory Requirements

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

Health Canada Guidance Documents

• 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

Application Forms 

New Licence Application

• 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

Licence Amendment Applications

• 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

Forms 

• Form F201- Change of a Manufacturer's Registration Status
• Form F202- Submission of a New or Modified Quality Management System Certificate