Health Canada
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Forms
Application forms listed below must accompany medical device applications filed by a manufacturer or sponsor.
- Application For a New Class IV Medical Device Licence - Update [2013-04-01]
- Application For a New Class III Medical Device Licence - Update [2013-04-01]
- Application For a New Class II Medical Device Licence - Updated [2013-04-01]
- Application for Investigational Testing Authorization [1999-02-22]
- Application for a Medical Device Licence Amendment for a Private Label Medical Device [2010-12-21]
- Application for a New Medical Device Licence for a Private Label Medical Device [2012-04-02]
- Bed-related Entrapment and Fall Report Form [2008-03-17]
- Class II Medical Device Licence amendment Application Form [2009-07-17]
- Class III Medical Device Licence amendment Application Form [2013-04-01]
- Class IV Medical Device Licence amendment Application Form [2013-04-01]
- Declaration of Conformity [2006-09-11]
- Investigator's Agreement in Accordance with Subsection 81(k) of the Medical Devices Regulations [2003-01-10]
- Licence Amendment Fax-Back Form - Guidance for Changes to the Name of a Device Licence for Existing Device Licences Only [2004-11-18]
- Medical Device Establishment Licence Application: Form and Instructions (FRM-0292) [2011-04-01]
- Medical Devices Licence Amendment Fax-Back Form - Guidance for Changes to the Manufacturer's Name and / or Address of Existing Device Licences Only [2004-07-23]
- Medical Devices Licence Amendment Fax-Back Form - Guidance for Non-Significant Additions / Deletions [2008-06-19]
