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
Thailand’s Medical Device Control Division has published guidelines on medical device product recalls. The document is intended to assist medical device manufacturers and other parties involved in operations with medical devices in ensuring compliance with the...
FDA
The Food and Drug Administration (FDA) has developed a guidance document dedicated to the benefit-risk factors to be considered when determining substantial equivalence in premarket notifications (510(k)) with different technological characteristics. The document is...
EU MDR/IVDR
The Health Products Regulatory Authority (HPRA), the Irish regulating authority in the sphere of medicines and medical devices, has published a draft guidance document dedicated to new applications for wholesale distribution authorizations (WDAs), as well as...
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