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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).
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.
There are seven classification rules that are given in Annex VIII. MDCG guidance 2020-16 provides clarification of the classification rules and gives classification examples. [1] Only devices in the lowest risk class, class A, are excluded from the requirement of notified body oversight.
This category includes devices similar to medical devices, as listed in Annex XVI. The classification rules of Annex VIII of the MDR have been expanded, compared to the MDD, to now 22 rules. Classification changes relate to software (rule 11), nanomaterials (rule 19), and substance-based medical devices (rule 21).
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 rules and regulations. Amongst these rules and regulations are: Directive 65/65/EEC1, requires prior approval for marketing of proprietary medicinal products
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.
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