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Produto: Equipamento Medico-odontológico
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O Ponto Focal da França respondeu o seguinte sobre exportação de equipamento medico-odontológico:
Further to your request regarding medical devices, please note that you will find all the necessary information on standards and rules on the following web site:
http://www.newapproach.org/Directives/DirectiveList.asp
Medical devices have become an increasingly important health care area in relation to their impact on health and health care expenditure. The sector covers some 8000 types of products, ranging from simple bandages and spectacles, through life maintaining implantable devices, equipment to screen and diagnose disease and health conditions, to the most sophisticated diagnostic imaging and minimal invasive surgery equipment.
There are 3 European directives about medical devices:
90/385/EEC Medical devices: Active implantable
93/42/EEC Medical devices: General
98/79/EC Medical devices: In vitro diagnostic
You will find all the information about the harmonised standards of each of these directive on the above website.
Useful links:
French legal texts can be found on the following website:
www.legifrance.gouv.fr
European legal texts:
http://eur-lex.europa.eu/fr/index.htm
http://midipy.sante.gouv.fr/santehom/vsv/vigilanc/materio/maint_dm.htm
Utilize a base de informações do Ponto Focal para saber sobre novas notificações e inscreva-se no Alerta Exportador!
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