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...
FDA
The Food And Drug Administration (FDA), the US regulating authority in the sphere of medical devices, has published a guidance document describing the process related to requesting a review of the FDA`s decision not to issue certain export certificates for medical...
North America
The US medical device circulation regulating authority, the Food and Drugs Administration (FDA), has issued guidance describing the issues related to denial in handling an export certificate. The Scope of the Guidance: Export Certificates The guidance is...
