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The Brazilian Health Regulatory Agency (Portuguese: Agência Nacional de Vigilância Sanitária, Anvisa, literally National Health Surveillance Agency) is a regulatory body of the Brazilian government, created in 1999 during President Fernando Henrique Cardoso's term of office.
The Brazilian Controlled Drugs and Substances Act (Portuguese: Regulamento Técnico sobre substâncias e medicamentos sujeitos a controle especial), officially Portaria nº 344/1998, [1] is Brazil's federal drug control statute, issued by the Ministry of Health through its National Health Surveillance Agency (Anvisa).
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.
EU legislation requires that each Member State operates to the same rules and requirements regarding the authorisation and monitoring of medicines. [ 20 ] Within the EU, EudraLex maintains the collection of rules and regulations governing medicinal products in the European Union, and the European Medicines Agency acts to regulate many of these ...
The Global Harmonization Task Force (GHTF) was “a voluntary group of representatives from national medical device regulatory authorities (such as the U.S. Food and Drug Administration (FDA)) and the members of the medical device industry” [1] whose goal was the standardization of medical device regulation across the world.
In 1970, the study committee recommended a classification for medical devices based on comparative risk. [5] In 1976, the Dalkon Shield intrauterine device injured at least 900,000 women in the United States, [ 6 ] which aided the emphasis for regulatory oversight and therapeutic requirements provided by the U.S. legislation P.L. 94-295.
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
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.