Product Monograph (PM) If Brochure (IB)’: *Please upload Investigator Brochure (IB): ‘Investigator Upload Document If Monograph (PM)’: *Please upload Product Monograph (PM): ‘Product Upload Document *Please indicate the status of the Health Canada Clinical Trial Application: Notice of Authorization pending Notice of Authorization enclosed If of Authorization Enclosed’: *Please upload document: ‘Notice Upload Document Medical Devices These questions appear only if Devices’ was selected from list in question 2.18. ‘Medical *Health Canada medical device classification: Class I Class II Class III IV If an Investigational Testing Application (ITA) the Medical Device Regulations’ selected in question ‘Yes – 2.18a, the following questions appear: *Name of all device components, parts and/or accessories as per product label for devices covered under the ITA with Health Canada: Add Another *Please indicate the status of the device(s) with Health Canada (select all that apply): Licensed (e.g., has Medical Device License (MDL)), but being used outside of current Health Canada authorization Investigational If (e.g. has Medical Device License (MDL)), but being used outside of current Health Canada ‘Licensed authorization’: *Describe how the device component, parts and/or accessories is/are being used in the study outside of the parameters of the conditions of use approved by Health Canada: *Does this device contain a drug? Yes No If *Drug used: ‘Yes’: *For each device covered under the ITA, upload the Product Monograph (PM) or equivalent: *Please upload PM or equivalent: Upload Document US Regulatory Requirements
Product Monograph (PM) If ‘Investigator Brochure (IB)’: *Please upload Investigator Brochure (IB): Upload Document If ‘Product Monograph (PM)’: *Please upload Product Monograph (PM): Upload Document *Please indicate the status of the Health Canada Clinical Trial Application: Notice of Authorization pending Notice of Authorization enclosed If ‘Notice of Authorization Enclosed’: *Please upload document: Upload Document Medical Devices These questions appear only if ‘Medical Devices’ was selected from list in question 2.18. *Health Canada medical device classification: Class I Class II Class III IV If ‘Yes – an Investigational Testing Application (ITA) the Medical Device Regulations’ selected in question 2.18a, the following questions appear: *Name of all device components, parts and/or accessories as per product label for devices covered under the ITA with Health Canada: Add Another *Please indicate the status of the device(s) with Health Canada (select all that apply): Licensed (e.g., has Medical Device License (MDL)), but being used outside of current Health Canada authorization Investigational If ‘Licensed (e.g. has Medical Device License (MDL)), but being used outside of current Health Canada authorization’: *Describe how the device component, parts and/or accessories is/are being used in the study outside of the parameters of the conditions of use approved by Health Canada: *Does this device contain a drug? Yes No If ‘Yes’: *Drug used: *For each device covered under the ITA, upload the Product Monograph (PM) or equivalent: *Please upload PM or equivalent: Upload Document US Regulatory Requirements
CTO-Provincial-Initial-Application-Form_Version-16-2016MAR14.docx