大家好
在下是在一家医疗器械公司工作,这次有幸拿到一个小订单,不想货被扣在了目的港机场,要被遣返。本来不应该有什么问题,客户要的文件都发了,可是客户说我们这个折叠拐的ce认证是根据mdd指令来的,没有用,问我们有没有除了根据mdd指令的其他ce认证。可是折叠拐就是医疗器械类的,貌似只能用93/42/eec指令额。下面是客户的原话,请大神们看一下,这问题到底是出在哪?有没有解决的法?在家感激不尽:
i need document according ce mark but holmogated withouth medical device directive 93/42/cee. if you he this product homologated in europe with ce mark but not according this directive 93/42/cee. there are some products which the manufacture could homologate two times one of this according this directive but also without according this directive. for example pill boxes, ear taps...do you understand me?
i explain you why we need this document, it is to oid pharmacist inspector in spanish custom because all goods according only this directive 93/42/cee must be checked for this people staff but if the product he ce mark but not according obbligatory with this directive 93/42/cee could be checked for another people different to introduce the goods in spain...[收起]