FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a general guidance document dedicated to labeling for medical devices. The document describes in detail the general labeling...
Canada
Health Canada, a Canadian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to inspections of medical device establishments. The current version of the document was published in November 2016 and replaced the...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has issued a guidance document dedicated to the procedures for handling post-approval studies imposed by premarket approval application orders. The...
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...
Canada
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...
Uncategorized
The Saudi Food and Drug Authority (SFDA), the country’s regulating authority in the sphere of medical devices, has published guidance dedicated to the labeling requirements medical devices should comply with in order to be allowed for marketing and use. Regulatory...
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