Medical device application forms

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 [2020-04-16]
• Application For a New Class IV Medical Device Licence - Updated
  (PDF fillable/saveable (579 K)) [2021-11-22]
   (DOC Version - 1.23 MB)
• 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]