Medical Device Application Forms
Application forms listed below must accompany medical device applications filed by a manufacturer or sponsor.
- Use this version of the Medical Devices Licence Application Fee Form if you will be filing on or after April 1, 2017.
Medical Devices Licence Application Fee Form
(PDF fillable/saveable (530 KB) [2017-03-03]
(Doc Version 99 KB) - Application For a New Class IV Medical Device Licence - Updated
(PDF fillable/saveable (227 K)) [2016-06-10]
(DOC Version - 141 K) - Application For a New Class III Medical Device Licence - Updated
(PDF fillable/saveable (1,430 K)) [2016-07-14]
(DOC Version - 136 K) - New Class II Medical Device Licence Application Form - Updated
(PDF fillable/saveable (2970 K)) [2016-06-13]
(DOC Version - 141 K) - 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
(PDF fillable/saveable (1,405 K)) [2016-06-27]
(Doc Version - 42 K) - Class IV Medical Device Licence Amendment Application Form
(PDF fillable/saveable (228 K)) [2016-06-09]
(DOC Version - 141 K) - Class III Medical Device Licence Amendment Application Form
(PDF fillable/saveable (297 K)) [2016-06-20]
(DOC Version - 131 K) - 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]
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