![\"\"](\"http:\/\/kuno-cpa.co.jp\/vietnam_blog\/wp-content\/uploads\/2018\/12\/hiroki_kawamura.jpg\")
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\n\u524d\u56de\u306e\u30d6\u30ed\u30b0\u3067\u3001\u533b\u7642\u6a5f\u5668\u306e\u8f38\u51fa\u5165\u3092\u884c\u3046\u305f\u3081\u306b\u306f\u88fd\u54c1\u3092\u30d9\u30c8\u30ca\u30e0\u306e\u4fdd\u967a\u5c40\u306b\u7533\u8acb\u3001\u767b\u9332\u3092\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u65e8\u3054\u7d39\u4ecb\u3055\u305b\u3066\u3044\u305f\u3060\u304d\u307e\u3057\u305f\u3002
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\u653f\u4ee436\/2016, 169\/2018 \/ ND-CP\u306e\u7b2c17\u6761\u306b\u3088\u308a\u307e\u3059\u3068\u3001
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Article 17. Requirements for registration of medical devices
\n1. Any medical devices to be registered and placed on the market must satisfy the following requirements:
\na) Having an effective registration number or having obtained permission for import according to provisions of this Decree;
\nb) Having label or supplementary label containing sufficiently information specified in Article 54 of this Decree;
\nc) Having technical documents serving the repair and maintenance of medical devices, excluding disposable medical devices prescribed by its owner;
\nd) Having Vietnamese instruction of how to use the medical devices;
\ndd) Having information about warranty establishments, conditions and duration, unless the device is disposable as decided by its owner.<\/p>\n
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2. The information specified in points c, d and dd clause 1 of this Article, which is not enclosed with the device, must be provided in form of electronic information; guidelines for accessing to such information must be clearly stated on the label of the medical devices.<\/p>\n
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