Medical device application and report forms
Application forms listed below must accompany medical device applications filed by a manufacturer or sponsor.
- Regulatory enrolment process (REP) for medical devices [2026-04-27]
- Medical Device Licence Application Fee Form [2025-03-21]
- Health Canada and FDA eSTAR pilot: Notice to industry [2023-01-10]
- Medical Device Foreign Risk Notification [2022-06-10]
- 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) - Bed-related Entrapment and Fall Report Form [2008-03-17]
- Declaration of Conformity [2006-09-11]
- Medical Device Establishment Licence (MDEL) application: instructions (FRM-0292) [2020-04-01]
Application forms listed below can be used in accordance with the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations
- Application form for Medical Device Clinical Trials Under the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations
(PDF version – 423 KB) [2022-04-21]
(DOC version - 134 KB) [2022-04-21] - Application Form for an Amendment to a Medical Device Clinical Trial under the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations
(PDF version – 504 KB) [2022-04-21]
(DOC version - 136 KB) [2022-04-21]