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Produto: Equipamento Médico-odontológico
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O Ponto Focal de Israel respondeu o seguinte sobre exportação de equipamento médico-odontológico:
The relevant articles are as detailed below:
The Regulatory Affairs Journal (Devices), 1998,Volume 6 (1) and 6 (4).
The Regulatory Affairs Journal (Devices), 1999, Vol. 7 (3), 256-258
As for importation guidelines:
A minimal amount of devices may be imported into Israel without being registered, on condition that these devices are approved for use by health authorities we recognize, such as the USA, Canada, Australia, and Europe (CE Marked). Please note we do not accept US approvals for use overseas only.
If interested in continuous export into Israel, one must register their product at our unit. In case so-and-so decides to register their product, we have detailed additional information they may need:
Only a local representative may submit an application for registration of a medical device in Israel, and the approval will be in his name. The application must be made in Hebrew. However, additional documentation submitted as part of the application form (certification documents etc.) do not need to be translated if it is in English.
The registration coordinator of Medical Devices contact:
Medical Device Department
Bldg. 130, Sheba Medical Center
Tel-Hashomer, 52621
Tel: 972 3 5303291/2
Fax: 972 3 5344552
Medical Equipment, Pharmaceuticals - Chamber of Commerce:
84 Ha'hashmona'im Street
Tel Aviv, 67132
Tel: 972-3-5631012, Fax: 972-3-5621245
Israeli ministry of health Internet site: http://www.health.gov.il
Utilize a base de informações do Ponto Focal para saber sobre novas notificações e inscreva-se no Alerta Exportador!
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