Medical device application and report forms

Application forms listed below must accompany medical device applications filed by a manufacturer or sponsor.

• 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)
• Medical Device Licence Application Fee Form [2023-04-01]
• Application For a New Class IV Medical Device Licence - Updated
  (PDF fillable/saveable (721 K)) [2022-07-11]
  (DOC Version - 150 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 (2108 K)) [2022-08-10]
  (DOC Version - 131 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 (512 K)) [2022-08-10]
  (Doc Version - 140 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 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]