Philippines
The Philippines Food and Drug Administration (FDA), the country’s regulating authority in the sphere of medical devices, has published for public comments and feedback draft guidance on the use of the official portal for applying for licenses required to conduct...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has developed a guidance document dedicated to Pre-Requests for Designation (Pre-RFD). The document describes the approach to be applied by...
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 or the Agency), the US regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document describing how to write a Request for Designation (RFD). The document is intended to...
Australia and Oceania
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of medical devices and other healthcare products, has published a checklist intended to assist medical device manufacturers and other parties involved in conducting a...
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