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我们工厂做的是眼镜设备, 有巴西客户要求我们提供以下的一些文件,还要经过大使馆认证, 可我打电话到大使馆, 他们又说要先找其他地方认证, 如贸促会等. 具我所知, 一般的认证都有个名称的, 如CE, 他这个又没有, 觉得是一堆零散的资料, 请问有没高手知道这个究竟怎么做呢? 下面是客户的信件, 请帮我看一下这些到底怎么做. 十分感谢
As Mario informed, please find below the list of documents necessary to register products at ANVISA (National Health Surveillance Agency) of the Brazilian Ministry of Health:
. Certificate of Free Sale (it needs to list all current models or product name). This
document must be notorized and authenticated by the Brazilian Embassy or Consulate.
. CE Certificate or FDA product registration
. Product name, complete description and specifications, presentation contents, type
of packaging internal, external and labelling.
. Indication of use
. Safety and Efficacy Studies (clinical studies/bibliographical references published in
scientific journals)
. Service and Operator manual
. Quality Assurance
. Catalogues/Brochures with illustration of the equipment
Notes:
. All documents which ARE NOT ORIGINALS must be an authenticated copy.
. Documents that are signed must be notorized and authenticated at the
Brazilian Embassy or Consulate.
[ 本帖最后由 江苏小林 于 2007-7-9 16:48 编辑 ]
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发表于 2007-7-5 12:03:00
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