Draft Guidance Document: Applications for Medical Device Investigational Testing Authorizations
This draft guidance document reflects Health Canada’s current thinking on Investigational Testing Authorizations (ITA) for medical devices and may be subject to changes as policy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 ITA application and filing requests for revisions to an ITA.
Multi-Society Consensus Conference and Guideline on the Treatment of Gastroesophageal Reflux Disease (GERD) - A SAGES Publication
The next generation of evidence-based medicine
Current Medical Device Regulations in Canada
Decentralized Procedure for Marketing Authorization in EU (1-2) 5.
Demystifying The Investigational Device Exemption Process - Healthcare - United States
Class II - IV Medical Device Investigational Testing in Canada - Vantage BioTrials
Class II - IV Medical Device Investigational Testing in Canada - Vantage BioTrials
Ultimate Guide to UDI for Medical Devices
A Guide to Bringing a Medical Device to Market
Medical device submissions: Placing a medical device on the market
Guidance document: preparation of regulatory activities in non-eCTD format
eCRF: Electronic Case Report Form in Clinical Trials - Essential Guide
Medical device - Wikipedia
Essential Documents Required for Conducting Clinical Trials
RQM+ Medical Device and In Vitro Diagnostic Blog