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...
FDA
The Taiwan Food and Drug Administration (FDA) has published technical guidelines for medical device software inspection and registration of Artificial Intelligence and Machine Learning technology. The new approach is based on the regulations adopted in the United...
FDA
The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical devices and other healthcare products, announced the new improvements and amendments to the Software Precertification Pilot Program. FDA Pre-Cert Pilot Program in Brief...
COVID-19
The Saudi Food & Drug Authority (SFDA), the regulating authority in the sphere of medical devices in Saudi Arabia, has published a guidance document dedicated to the requirements for unique device identification (UDI) for medical devices. The present document...
FDA
The Food and Drugs Administration (FDA), the US authority responsible for medical device regulation, has published a guidance document dedicated to the annual reports for Pre-market Approval Applications (PMA) that have been approved. Regulatory Background According...
Gartner® Market Guide for Life Science Regulatory Information Management Solutions
Download NowGartner® Market Guide for Regulatory Intelligence Solutions
Download Now
