United States
The Association for the Advancement of Medical Instrumentation (AAMI) has published a Consensus Report intended to provide guidance regarding the safety-related aspects to be considered by the medical device manufacturers in the context of the Emergency Use...
EU MDR/IVDR
The European Commission (EC), a union-wide authority responsible for medical devices regulations, has announced the launch of the first of six EUDAMED modules – the Actor registration module. Intended Purpose According to the official announcement published by...
Saudi Arabia
The Saudi Food and Drug Authority (SFDA) of Saudi Arabia has published guidance for overseas manufacturers, intended to provide foreign medical device manufacturers interested in placing their products on the market of the Kingdom of Saudi Arabia (KSA) with additional...
FDA
The US Food and Drug Administration (FDA) has issued a guidance dedicated to the benefit-risk factors to be considered in the context of product availability, compliance, and enforcement decisions with regard to the medical devices. Notes The document describes the...
FDA
The Food and Drug Administration (FDA) has published guidance on certificates of confidentiality. The document is intended to provide additional clarifications to study sponsors, investigators, researchers, and other industry representatives. All interested parties...
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