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TGA Guidance on Certificates of Free Sale and Export Certificates
Jun 2, 2021
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices,
has published guidance dedicated to certificates of free sale and export certificates.
The document describes in detail the eligibility criteria and how...
FDA on Investigational Device Exemptions for Early Feasibility Studies
Jun 2, 2021
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to investigational device exemptions (IDEs) for early feasibility medical device clinical studies. The scope...
Health Canada Guidance on Applying for an MDEL
Jun 2, 2021
Health Canada, the Canadian regulating authority in the sphere of medical devices, has published a guidance document describing the most important aspects
related to the medical device establishment license (MDEL),
special permission necessary to carry out the...
TGA Guidance on Certificates of Free Sale and Export Certificates
Jun 2, 2021 Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published guidance dedicated to certificates of free sale and export certificates. The document describes in detail the eligibility criteria and how...
