加拿大外贸
Can I have the EC certificate of full quality assurance system according to Annex IV, article 3.这是什么意思啊！详细点。。。谢谢
我是做血糖仪（glucose meter）的
[ 本帖最后由 a469653720 于 2010-9-3 17:38 编辑 ]
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啊，你是做什么行业的？讲全点，其他人易帮到你
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问客人能不能把这文章(Annex IV, article 3)发给你看,然后按照文章上的内容给客人做一个带有质量保证的EC证书。
仅供参考。
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我们做的是迷你药物冷藏箱， 应该属于小家电行业的
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欧盟生产医疗电子设备的认证，原文可查：
http://www.tecnologias-sanitarias.com/MD/DIR_MD_9342/d9342a4.htm
3. The manufacturer must undertake to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:
(i) any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;
(ii) any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.
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