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Produto: Aparelhos eletrônicos para fisioterapia e estética
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O Ponto Focal da Bulgária respondeu o seguinte sobre exportação de aparelhos eletrônicos para fisioterapia e estética:
The Bulgarian legislation in force for mechano-therapy appliances at the time being, is as follows:
- Ordinance on the essential requirements and conformity assessment of electrical equipment designed for use within certain voltage limits (published in State Gazette No.62/2001, last amendment State Gazette No.74/2003). Transposing Directive 73/23/EEC.
- Ordinance on the essential requirements and conformity assessment of electromagnetic compatibility (published in State Gazette No.78/2001, last
amendment State Gazette No.65/2004). Transposing Directive 89/336/EEC.
- Law of drugs and pharmacies in human medicine, (published in State Gazette No.36/18.04.1995, last amendment State Gazette issue 2/07.01.2003)
- Ordinance on the order and conditions for permission of use of medical products according to art. 3, par. 3 and par.5 from Law of drugs and pharmacies in human medicine, (published in State Gazette issue 76/15.09.2000)
- Ordinance ? 7 for obligatory data on the packaging and on the leaflets of drug products, and on the instructions for use of medical devices. (published in State Gazette No.54/2000, last amendment State Gazette No.17/2004).
A draft ordinance transposing the Directive on medical devices, 93/42/EEC, is in a process of implementation in the Bulgarian legislation.
For the matter concerning medical devices you could contact also the Bulgarian Drug Agency:
Tel.: +35929434046
Fax: +35929434487
E-mail:
bda@bda.bg
Web Site:
www.bda.bg
Utilize a base de informações do Ponto Focal para saber sobre novas notificações e inscreva-se no Alerta Exportador.
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