Saudi Arabia
The Saudi Food and Drug Authority (SFDA) of Saudi Arabia has published guidance for importers and distributors. The document is intended to provide additional clarifications regarding the applicable rules and requirements the parties involved in operations with...
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...
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