Asia
The Philippines Food and Drug Administration (FDA) has published a circular implementing the interim guidelines describing the conduct of licensing inspections for radiation facilities. In the case of any discrepancies, the provisions of the new circular shall...
Saudi Arabia
The Saudi Food and Drug Authority (SFDA) of Saudi Arabia has published a guidance document dedicated to the rights and responsibilities of the authorized representatives of the foreign medical device manufacturers. The scope of the document covers both pre-license and...
United States
The Centers for Medical & Medicaid Services (CMS), a part of the US Department of Health and Human Services (HHS), has published a policy on Artificial Hearts and related devices, including Ventricular Assist Devices for Bridge-to-Transplant and Destination...
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...
#WednesdayWebinar Join us for our upcoming webinar Global Regulatory Changes to Expect in 2025 January 22, 2025 at 10 AM ET
Register Now
