阿根廷医疗器械注册

阿根廷注册主管当局是Direccion de Tecnologia Medica, Administracion National de Medicamentos, Alimentos y Tecnologia Médico (ANMAT) 国家药品、食品和医疗技术管理局,网址 http://www.anmat.gov.ar/principal.asp 阿根廷器械分类 1-4 如下表:

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一类医疗器械只需要提交一些相对简单的文件即可。二类、三类和四类需要提交产品分类信息、生产商信息、标签、使用说明和产品符合技术规范的技术文件。AMNAT还必须提交一个自由销售证明,需要来自国家(澳大利亚,加拿大,日本,美国,欧洲),需要任命一名负责注册程序的当地授权代表作为注册人,由这个注册人提交文件到ANMAT,所有文件和标签必须翻译成西班牙文,以便完成注册持证。

阿根廷注册流程如下:

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注册所需文件资料:

1. If device does not have CFS from recognized country then a Good Manufacturing Practices (GMP), which is similar to ISO 13485 and QSR certificate will be required.

2. A distributor or third-party company must be appointed to obtain GMP.

3. If company selects distributor as registration holder, it is extremely difficult to switch distributors without full cooperation. It is therefore recommended that companies choose a representative that is not involved in device sale.

4.Protocol Analysis or Certificate of Analysis. This document is authored by the manufacturer’s quality control division or technical staff, which may be a physician, engineer, biochemist, or other designer, depending on the nature of the product.

5 .Operation Manual. Instructions for use must be specific for each model.

6. Catalogs must provide technical specifications, and accessories lists, wherever applicable.

7. Labeling

8. certificate issued by the original


本文由作者转载,原文信息如下:

原文标题:阿根廷医疗器械注册

原文作者:赵旭刚

原文地址:https://www.linkedin.com/pulse/阿根廷医疗器械注册-旭刚-赵?articleId=6559998735814889472

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