Draft Guidance Document: Applications for Medical Device Investigational Testing Authorizations From Health Canada π¨π¦ This draft guidance document reflects Health Canadaβs current thinking on Investigational Testing Authorizations (ITA) for medical devices and may be subject to changes as policy develops. The document clarifies application requirements and processes, including pre-ITA meetings, format for an ITAβ¦ Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on October 18, 2021 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Notice: Use of United States Food and Drug Administration (FDA) Guidance Materials to support Canadian Medical Devices Licence Applications From Health Canada π¨π¦ TThis notice is to remind manufacturers of their obligations under the Medical Devices Regulations when applying for medical device licences or Investigational Testing authorization, where these devices are intended to be used together or with other medical devices. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 19, 2021 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Applications for Medical Device Investigational Testing Authorizations Guidance Document - Summary From Health Canada π¨π¦ Applications for Medical Device Investigational Testing Authorizations Guidance Document - Summary Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on November 9, 2018 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Notice: Applications for Medical Device Investigational Testing Authorizations β Changes to the Timing of Research Ethics Board (REB) Approval From Health Canada π¨π¦ Notice: Applications for Medical Device Investigational Testing Authorizations β Changes to Information Requirements Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on October 1, 2018 Open Government License 2.0 (Canada) 0 reuses 0 favorites