Medical device application and report 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.

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]
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