FDA
The Food And Drug Administration (FDA), the US regulating authority in the sphere of medical devices, has published guidance on micro-needling products. Notes The present document constitutes a final version of the draft guidance issued previously in September 2017....
FDA
The Food and Drug Administration (FDA), the US regulating authority, has updated the information materials dedicated to importing and exporting medical devices. Importing and Exporting: the Basics According to the general rule, the entity involved in the...
FDA
The Saudi Food and Drug Administration (SFDA) issued updated guidance requirements for medical device listing and marketing authorization. The document is intended to provide medical device manufacturers, their authorized representatives, distributors, and other...
FDA
The European Commission issued a Question and Answer document in order to provide medical device manufacturers with the information regarding the way the new Manufacturer Incident Report (MIR) Form shall be implemented. New Manufacturer Incident Report Form in Brief...
FDA
The Food and Drug Administration (FDA) issued guidance dedicated to the digital health devices used to treat psychiatric disorders in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus “SARS-CoV-2” or the “novel coronavirus” and...
