Guidance Documents

Guidance documents have been prepared to assist in the interpretation of policies and governing statutes and regulations. They are intended to assist in preparing the various device licence applications required when seeking an authorization to sell a medical device product in Canada. Guidance documents are designed to be living documents and will be revised as necessary.

	Cost Recovery
	Medical Devices Guidance Documents
	Medical Devices Global Harmonization Task Force

Cost Recovery

	How to Pay Fees Date: 2004-11-22
	Guidance Document on Cost Recovery - Fees in Respect of Medical Devices Date: 2002-02-01

Medical Devices Guidance Documents

	Draft Guidance Document: Information to be Provided by Manufacturers for the Reprocessing and Sterilization of Reusable Medical Devices Date: 2006-12-04 Comments
	Notice: Updated Guidance on the Recognition and Use Of Standards under the Medical Devices Regulations Date: 2006-09-22
	Guidance Document: Recognition and Use of Standards under the Medical Device Regulations Date: 2006-09-22
	Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices Date: 2006-09-14
	Draft Guidance Document: Submission of Pharmacogenomic Information Date: 2006-03-07
	Guidance for Industry - Medical Device Licence Renewal Date: 2005-08-17
	Guidance for Industry: Device Licence Applications for Ultrasound Diagnostic Systems and Transducers Date: 2005-07-18
	Guidance for Industry - Private Label Medical Devices Date: 2005-06-01
	Private Label Medical Devices: Questions and Answers Date: 2005-06-01
	Guidance for Industry: How to Complete the Application for a New Medical Device Licence/Medical Device Licence Amendment for a Private Label Medical Device Date: 2005-06-01
	Application for a New Medical Device Licence for a Private Label Medical Device Date: 2005-06-01
	Application for a Medical Device Licence Amendment for a Private Label Medical Device Date: 2005-06-01
	Guidance document on the Regulation of Medical Devices Manufactured from or Incorporating Viable or Non-Viable Animal Tissue or their Derivative (s) Date: 2004-07-12
	Guidance for the Labelling of Medical Devices under Section 21 to 23 of the Medical Devices Regulations, Appendices for Labelling: Soft Contact Lenses and Menstrual Tampons Date: 2004-06-12
	Pre-Market Guidance on Bare Cardiovascular Stents Date: 2004-04-08
	Guidance for the Interpretation of Significant Change V.3 Date: 2003-03-20
	Notice to Industry - Risk Classification of Diagnostic Ultrasound Systems and Transducers Date: 2002-05-09
	Preparation of a Premarket Review Document for Breast Implant and Tissue Expander Applications Date: 2001-02-05
	Preparation of an Application for Investigational Testing - Medical Devices V.3 Date: 1999-02-22
	Preparation of an Application for Investigational Testing - In Vitro Diagnostic Devices (IVDD) V.3 Date: 1999-02-22
	Guidance for the Interpretation of Sections 28 to 31: Licence Application Type - Draft Date: 1999-01-12
	Guidance on How to Complete the Application for a New Medical Device Licence V.4 Date: 1999-01-06
	Preparation of a Premarket Review Document for Class III and Class IV Device Licence Applications V.2 Date: 1998-10-23
	Notice to Industry - Licensing Requirements for Inter-dependent Medical Devices Date: 2002-05-07
	Guidance for the Labelling of In Vitro Diagnostic Devices - DRAFT Date: 1998-06-19
	Guidance for the risk based classification system - DRAFT Date: 1998-05-04
	Guidance for the risk based classification system of in vitro diagnostic devices - DRAFT Date: 1998-04-24

Medical Devices Global Harmonization Task Force

	Guidance for Manufacturers Preparing a Premarket Application Using the Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices Date: 2003-10-02
	Notice to Industry - Pilot Premarket Review Program for Medical Devices Date: 2001-12-10