Search results
Results from the WOW.Com Content Network
Saudi Food and Drug Authority (SFDA) (Arabic: الهيئة العامة للغذاء والدواء) is an independent body for the Kingdom of Saudi Arabia that aims to ensure food and drug safety for the nation. The Authority was founded in August 29, 2003. [1]
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
Medical Devices regulations cover all the topics related to the laws, standards or submissions process, with which compliance is required by manifold national and international bodies to commercialize a medical device
The 1990 Safe Medical Device law originated after an eight-year U.S. congressional inquiry of the Medical Device Amendments of 1976. The 1976 legislation deviated the clarification and proper evaluation of competitive or "substantial equivalence" medical devices. [4]
Device Warning Letters (except those issued to IRBs, clinical investigators, sponsors, and monitors involved in clinical trials) include the notice, "Federal agencies are advised of all Warning Letters about devices so that they may take this information into account when considering the award of contracts."
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.
Pages in category "Medical device manufacturers" The following 57 pages are in this category, out of 57 total. This list may not reflect recent changes. A.