Medical device application forms
For industry information about COVID-19, visit our COVID-19 medical devices section.
Application forms listed below must accompany medical device applications filed by a manufacturer or sponsor.
- Medical device problem report form for health care professionals [2019-06-26]
- Application Form for New Investigational Testing Authorization (ITA)
(PDF fillable/saveable (932 K)) [2018-11-07]
(DOC Version - 142 K) - Application Form for Revised Investigational Testing Authorization (ITA)
(PDF fillable/saveable (773 K)) [2018-11-07]
(DOC Version - 134 K) - Medical Device Licence Application Fee Form [2020-03-23]
- 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 Version (1193 K)) [2018-05-02]
(DOC Version - 144 K) - Application for a Medical Device Licence Amendment for a Private Label Medical Device [2020-04-01]
- Application for a New Medical Device Licence for a Private Label Medical Device [2020-04-01]
- Bed-related Entrapment and Fall Report Form [2008-03-17]
- Class II Medical Device Licence Amendment Application Form
(PDF fillable/saveable (247 K)) [2020-04-15]
(Doc Version - 249 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 [2020-05-06]
- Medical Device Establishment Licence (MDEL) application: instructions (FRM-0292) [2020-04-01]
- Medical Devices Licence Amendment Fax-Back Form - Guidance for Changes to the Manufacturer's Name and / or Address of Existing Device Licences Only [2020-04-21]
(PDF Version (130 KB))
(DOC Version - 30 KB) - Medical Devices Licence Amendment Fax-Back Form - Guidance for Non-Significant Additions / Deletions [2020-04-22]
Application forms listed below can be used in accordance with the Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19
- Application Form for Medical Device Clinical Trial under the Interim Order (COVID-19)
(PDF Version - 605 KB) [2020-09-10]
(DOC Version - 130 KB) [2020-06-11] - Application Form for Revision to Medical Device Clinical Trials under the Interim Order (COVID-19)
(PDF Version - 508 KB) [2020-09-10]
(DOC Version - 129 KB) [2020-06-11]
Report a problem or mistake on this page
- Date modified: