FDA
The Food and Drugs Administration (FDA) has published guidance on glucose monitoring systems intended to be used in healthcare facilities (point-care-use). The document constitutes a final version of the guidance issued previously by the Agency in November 2018. It is...
Asia
The Taiwan Food and Drug Administration (FDA) has published several draft guidance documents dedicated to the post-market activities related to medical devices marketed in Taiwan. In particular, the documents are covering the aspects related to the adverse events...
FDA
The Food and Drug Administration (FDA) has published a guidance document dedicated to the basic safety and essential performance of medical electrical equipment, medical electrical systems, and laboratory medical equipment. The document provides the standards-specific...
Saudi Arabia
The Saudi Food and Drug Authority (SFDA), the country’s regulating authority, has published a guidance document dedicated to the requirements for electronic instructions for use (eIFU) of medical devices. The document was initially published on August 22, 2019, for...
Poland
The Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products (URPL), the Polish regulating authority in the sphere of medical devices, published a detailed overview of the current regulatory framework in order to assist medical device...
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