{"id":3639,"date":"2025-11-30T09:29:00","date_gmt":"2025-11-30T02:29:00","guid":{"rendered":"https:\/\/productregistrationindonesia.com\/?p=3639"},"modified":"2025-12-10T22:12:10","modified_gmt":"2025-12-10T15:12:10","slug":"risk-and-regulation-why-chinese-medical-device-manufacturer-information-must-be-hyper-detailed-for-indonesian-registration","status":"publish","type":"post","link":"https:\/\/productregistrationindonesia.com\/zh\/risk-and-regulation-why-chinese-medical-device-manufacturer-information-must-be-hyper-detailed-for-indonesian-registration\/","title":{"rendered":"\u98ce\u9669\u4e0e\u76d1\u7ba1\uff1a\u4e3a\u4ec0\u4e48\u4e2d\u56fd\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u7684\u4fe1\u606f\u5fc5\u987b\u975e\u5e38\u8be6\u7ec6\u624d\u80fd\u5728\u5370\u5ea6\u5c3c\u897f\u4e9a\u6ce8\u518c\uff1f"},"content":{"rendered":"<p>\u5168\u7403\u533b\u7597\u5668\u68b0\u884c\u4e1a\u4e25\u91cd\u4f9d\u8d56\u6e90\u81ea\u4e2d\u56fd\u7684\u4f9b\u5e94\u94fe\u3002\u7136\u800c\uff0c\u5bf9\u4e8e\u5370\u5c3c\u7684\u5206\u9500\u5546\u548c\u8fdb\u53e3\u5546\u800c\u8a00\uff0c\u529e\u7406\u4ece\u4e2d\u56fd\u8fdb\u53e3\u533b\u7597\u5668\u68b0\u7684\u4e0a\u5e02\u8bb8\u53ef\u9700\u8981\u6781\u5176\u7cbe\u51c6\u7684\u6d41\u7a0b\uff0c\u5c24\u5176\u662f\u5728\u5236\u9020\u5546\u7684\u8eab\u4efd\u548c\u5730\u5740\u65b9\u9762\u3002.<\/p>\n\n\n\n<p>\u8bb8\u591a\u4e2d\u56fd\u4f01\u4e1a\u4f7f\u7528\u4ee3\u5de5\u5382\uff08CM\uff09\u7684\u505a\u6cd5\u5f15\u53d1\u4e86\u666e\u904d\u62c5\u5fe7\uff0c\u4fc3\u4f7f\u5370\u5c3c\u548c\u4e2d\u56fd\u7684\u76d1\u7ba1\u673a\u6784\u90fd\u8981\u6c42\u4e25\u683c\u9075\u5b88\u5730\u5740\u900f\u660e\u5ea6\u89c4\u5b9a\u3002\u672c\u6587\u5c06\u6df1\u5165\u63a2\u8ba8\u76d1\u7ba1\u4f9d\u636e\uff0c\u5e76\u89e3\u91ca\u4e3a\u4ec0\u4e48\u5730\u5740\u8be6\u60c5\u662f\u81f3\u5173\u91cd\u8981\u4e14\u4e0d\u5bb9\u59a5\u534f\u7684\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u5173\u952e\u70b9\uff1a\u4ee3\u5de5\u5236\u9020\uff08CM\uff09\u73b0\u8c61<\/h2>\n\n\n\n<p>\u8bb8\u591a\u4e2d\u56fd\u533b\u7597\u5668\u68b0\u516c\u53f8\uff0c\u4f5c\u4e3a <em>\u5408\u6cd5\u5236\u9020\u5546<\/em> \u6216\u8005\u54c1\u724c\u6240\u6709\u8005\uff0c\u5e76\u4e0d\u603b\u662f\u5728\u81ea\u5df1\u7684\u5de5\u5382\u751f\u4ea7\u8bbe\u5907\u3002\u4ed6\u4eec\u7ecf\u5e38\u5229\u7528\u5408\u540c\u5236\u9020\u5546 (CM) \u7684\u670d\u52a1\u6216\u4ece\u4e8b\u5176\u4ed6\u76f8\u5173\u5de5\u4f5c\u3002 <em>\u59d4\u6258\u751f\u4ea7<\/em>.<\/p>\n\n\n\n<p><strong>\u76f8\u5173\u98ce\u9669\uff1a<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u8d28\u91cf\u53ef\u8ffd\u6eaf\u6027\uff1a<\/strong> \u5982\u679c\u6ca1\u6709\u660e\u786e\u7684\u6807\u8bc6\u548c\u5730\u5740\uff0c\u4e00\u65e6\u51fa\u73b0\u8d28\u91cf\u95ee\u9898\uff08\u4ea7\u54c1\u53ec\u56de\u6216\u4e0d\u826f\u4e8b\u4ef6\uff09\uff0c\u76d1\u7ba1\u673a\u6784\u5f88\u96be\u8ffd\u8e2a\u5b9e\u9645\u7684\u751f\u4ea7\u5730\u70b9\u3002.<\/li>\n\n\n\n<li><strong>\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u5dee\u5f02\uff1a<\/strong> Kemenkes \u5ba1\u6838\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb (QMS)\uff08\u4f8b\u5982 ISO 13485\uff09\u5fc5\u987b\u7531\u5b9e\u9645\u751f\u4ea7\u573a\u6240\u6301\u6709\uff0c\u800c\u4e0d\u4ec5\u4ec5\u662f\u59d4\u6258\u65b9\u7684\u9500\u552e\u6216\u5e02\u573a\u8425\u9500\u529e\u516c\u5ba4\u3002.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">\u5370\u5ea6\u5c3c\u897f\u4e9a\u76d1\u7ba1\u8981\u6c42 (Kemenkes RI)<\/h2>\n\n\n\n<p>\u5370\u5c3c\u653f\u5e9c\u901a\u8fc7\u536b\u751f\u90e8\uff08Kemenkes\uff09\u91c7\u7528\u975e\u5e38\u5177\u4f53\u7684\u767b\u8bb0\u673a\u5236\u6765\u660e\u786e\u751f\u4ea7\u94fe\uff1a<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">A. \u6388\u6743\u4e66\u4e2d\u7684\u8be6\u7ec6\u5206\u7c7b<\/h3>\n\n\n\n<p>Kemenkes\u8981\u6c42\u901a\u8fc7\u59d4\u6258\u4eba\/\u5236\u9020\u5546\u7b7e\u7f72\u7684\u6388\u6743\u4e66\uff08LoA\uff09\u8fdb\u884c\u6f84\u6e05\u3002\u6388\u6743\u4e66\u4e2d\u5236\u9020\u5546\u540d\u79f0\u7684\u58f0\u660e\u683c\u5f0f\u5fc5\u987b\u901a\u8fc7e-Regalkes\u7cfb\u7edf\u63d0\u4ea4\uff0c\u5e76\u4e14\u5fc5\u987b\u53cd\u6620\u751f\u4ea7\u60c5\u51b5\uff0c\u5c24\u5176\u662f\u5728CM\uff08\u5408\u540c\u5236\u9020\uff09\u6848\u4f8b\u4e2d\uff1a<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th><strong>\u751f\u4ea7\u573a\u666f<\/strong><\/th><th><strong>Kemenkes \u63a5\u53d7\u7684\u683c\u5f0f\uff08\u793a\u4f8b\uff09<\/strong><\/th><th><strong>\u542b\u4e49<\/strong><\/th><\/tr><\/thead><tbody><tr><td><strong>\u81ea\u6211\u751f\u4ea7<\/strong><\/td><td>A\u5de5\u5382<\/td><td>\u5730\u5740 A \u4e3a\u5b9e\u9645\u751f\u4ea7\u5730\u70b9\u3002.<\/td><\/tr><tr><td><strong>\u6821\u957f\u4efb\u547dCM\u5de5\u5382<\/strong><\/td><td>A\u5de5\u5382\u4e3aB\u5de5\u5382<\/td><td>B \u662f\u8d1f\u8d23\u4eba\/\u54c1\u724c\u6240\u6709\u8005\uff1bA \u662f\u5b9e\u9645\u751f\u4ea7\u5730\u70b9\/CM\u3002.<\/td><\/tr><tr><td><strong>\u901a\u8fc7\u5408\u6cd5\u5236\u9020\u5546<\/strong><\/td><td>A\u81f3C\u5de5\u5382<\/td><td>C \u662f\u6cd5\u5b9a\u8d23\u4efb\u4eba <em>\u5408\u6cd5\u5236\u9020\u5546<\/em>; A \u662f\u5b9e\u9645\u751f\u4ea7\u73b0\u573a\/CM\u3002.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>\u5173\u952e\u89c1\u89e3\uff1a<\/strong> \u5370\u5c3c\u76d1\u7ba1\u673a\u6784\u8981\u6c42\u8fdb\u53e3\u5546\u660e\u786e\u58f0\u660e\u5b9e\u9645\u751f\u4ea7\u5730\u70b9\uff08A\uff09\uff0c\u6838\u5b9e\u8be5\u5de5\u5382\u5730\u5740\uff0c\u5e76\u786e\u4fdd\u8d28\u91cf\u6587\u4ef6\uff08\u5982 ISO 13485\uff09\u4ee5\u8be5\u7279\u5b9a\u751f\u4ea7\u5730\u5740\u7684\u540d\u4e49\u7b7e\u53d1\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">B. \u5f3a\u5236\u5ba3\u8a93\u7ffb\u8bd1<\/h3>\n\n\n\n<p>\u6240\u6709\u6e90\u81ea\u4e2d\u56fd\u7684\u6cd5\u5f8b\u6587\u4ef6\uff08\u4f8b\u5982\u91c7\u8d2d\u8ba2\u5355\u3001\u81ea\u7531\u9500\u552e\u8bc1\u660e\u3001\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\/ISO 13485\u8ba4\u8bc1\u6587\u4ef6\uff09\u5747\u987b\u9644\u6709\u5ba3\u8a93\u7ffb\u8bd1\u5458\u7684\u7ffb\u8bd1\u4ef6\u3002\u8fd9\u5bf9\u4e8e\u786e\u4fdd\u6240\u5217\u8eab\u4efd\u548c\u5730\u5740\u4fe1\u606f\u51c6\u786e\u65e0\u8bef\u81f3\u5173\u91cd\u8981\u3002.<\/p>\n\n\n\n<figure class=\"wp-block-embed is-type-wp-embed is-provider-product-registration-indonesia wp-block-embed-product-registration-indonesia\"><div class=\"wp-block-embed__wrapper\">\n<blockquote class=\"wp-embedded-content\" data-secret=\"P5KCWhRjW2\"><a href=\"https:\/\/productregistrationindonesia.com\/zh\/chinese-medical-device-registration-complete-guide-for-global-manufacturers\/\">\u4e2d\u56fd\u533b\u7597\u5668\u68b0\u6ce8\u518c\uff1a\u5168\u7403\u5236\u9020\u5546\u5b8c\u6574\u6307\u5357<\/a><\/blockquote><iframe class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; visibility: hidden;\" title=\"\u201c\u300a\u4e2d\u56fd\u533b\u7597\u5668\u68b0\u6ce8\u518c\uff1a\u5168\u7403\u5236\u9020\u5546\u5b8c\u6574\u6307\u5357\u300b\u2014\u2014\u5370\u5c3c\u4ea7\u54c1\u6ce8\u518c\" src=\"https:\/\/productregistrationindonesia.com\/chinese-medical-device-registration-complete-guide-for-global-manufacturers\/embed\/#?secret=h6hkjjXDtb#?secret=P5KCWhRjW2\" data-secret=\"P5KCWhRjW2\" width=\"600\" height=\"338\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe>\n<\/div><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">\u652f\u6301\u4e2d\u56fd\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u5173\u4e8eCMs\u7684\u76d1\u7ba1<\/h2>\n\n\n\n<p>\u4e2d\u56fd\u56fd\u5185\u7531\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u7ba1\u7406\u7684\u6cd5\u89c4\uff0c\u73b0\u5728\u652f\u6301\u6781\u5ea6\u900f\u660e\u7684\u5fc5\u8981\u6027\uff1a<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u52a0\u5f3a\u5bf9\u4ee3\u5de5\u751f\u4ea7\u7684\u76d1\u7ba1\uff1a<\/strong> \u56fd\u5bb6\u836f\u54c1\u7ba1\u7406\u5c40\u52a0\u5f3a\u4e86\u5bf9\u2026\u2026\u7684\u76d1\u7ba1 <em>\u53d7\u6258\u5236\u9020<\/em>. \u5c06\u751f\u4ea7\u5916\u5305\u7684\u516c\u53f8\u73b0\u5728\u5fc5\u987b\u5bf9\u5176\u5408\u540c\u5236\u9020\u5546\u7684\u80fd\u529b\u548c\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb (QMS) \u5408\u89c4\u6027\u8fdb\u884c\u6df1\u5165\u8bc4\u4f30\u3002.<\/li>\n\n\n\n<li><strong>\u6807\u7b7e\u900f\u660e\u5ea6\uff1a<\/strong> \u5bf9\u4e8e\u901a\u8fc7 CM \u5236\u9020\u7684\u8bbe\u5907\uff0c\u53cc\u65b9\u7684\u540d\u79f0\u548c\u5730\u5740\u2014\u2014 <em>\u5408\u6cd5\u5236\u9020\u5546<\/em> \uff08\u54c1\u724c\u6240\u6709\u8005\uff09\u548c <em>\u5408\u540c\u5236\u9020\u5546<\/em> \uff08\u5b9e\u9645\u751f\u4ea7\u5730\u70b9\uff09\u2014\u2014\u5fc5\u987b\u5728\u4ea7\u54c1\u6807\u7b7e\u3001\u8bf4\u660e\u4e66\u6216\u5305\u88c5\u4e0a\u6ce8\u660e\u3002.<\/li>\n<\/ol>\n\n\n\n<p>\u8fd9\u9879\u5f3a\u5236\u6027\u7684\u53cc\u6807\u7b7e\u8981\u6c42\u76f4\u63a5\u9a8c\u8bc1\u4e86\u83b7\u53d6\u9ad8\u5ea6\u51c6\u786e\u7684\u5730\u5740\u8be6\u7ec6\u4fe1\u606f\u4ee5\u8fdb\u884c\u6ce8\u518c\u7684\u5fc5\u8981\u6027\u3002.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p>\u5bf9\u4e8e\u5370\u5ea6\u5c3c\u897f\u4e9a\u7684\u5206\u9500\u5546\u548c\u8fdb\u53e3\u5546\u800c\u8a00\uff0c\u4ece\u4e2d\u56fd\u6ce8\u518c\u533b\u7597\u5668\u68b0\u7684\u7cbe\u786e\u6027\u4e0d\u4ec5\u5173\u4e4e\u5408\u89c4\u6027\uff0c\u66f4\u5173\u4e4e\u98ce\u9669\u7f13\u89e3\u3002.<\/p>\n\n\n\n<p>\u672a\u80fd\u51c6\u786e\u3001\u5b8c\u6574\u5730\u8bf4\u660e\u5b9e\u9645\u751f\u4ea7\u5730\u70b9\uff08\u5982\u9002\u7528\uff0c\u5305\u62ec\u5b8c\u6574\u7684CM\u5730\u5740\uff09\u53ef\u80fd\u5bfc\u81f4\u4ee5\u4e0b\u540e\u679c\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Kemenkes \u9a73\u56de\u4e86\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\u3002.<\/li>\n\n\n\n<li>\u5982\u679c\u6587\u4ef6\u4e0a\u7684\u5730\u5740\u4e0e\u5b9e\u9645\u751f\u4ea7\u5730\u70b9\u4e0d\u7b26\uff0c\u5219\u5ba1\u6838\u4e0d\u5408\u683c\u3002.<\/li>\n\n\n\n<li>\u672a\u6765\u4ea7\u54c1\u53ec\u56de\u98ce\u9669\u3002.<\/li>\n<\/ul>\n\n\n\n<p>\u56e0\u6b64\uff0c\u52a1\u5fc5\u5411\u60a8\u7684\u4e2d\u56fd\u59d4\u6258\u4eba\u5f7b\u5e95\u4e86\u89e3\u5b9e\u9645\u751f\u4ea7\u5730\u70b9\uff0c\u5e76\u6838\u5b9e\u6240\u6709\u6cd5\u5f8b\u6587\u4ef6\u662f\u5426\u53cd\u6620\u8be5\u5177\u4f53\u5730\u5740\u3002.<\/p>","protected":false},"excerpt":{"rendered":"<p>The global medical device industry heavily relies on the supply chain originating from China. However, for distributors and importers in Indonesia, processing the Marketing Authorization for imported medical devices from China requires extreme precision, especially concerning the manufacturer&#8217;s identity and address. The common concern that many Chinese companies use Contract Manufacturers (CMs) has prompted regulators, [&hellip;]<\/p>\n","protected":false},"author":7,"featured_media":3641,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[45],"tags":[],"country":[],"class_list":["post-3639","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-device-articles"],"acf":[],"_links":{"self":[{"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts\/3639","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/comments?post=3639"}],"version-history":[{"count":0,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts\/3639\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/media\/3641"}],"wp:attachment":[{"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/media?parent=3639"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/categories?post=3639"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/tags?post=3639"},{"taxonomy":"country","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/country?post=3639"}],"curies":[{"name":"\u53ef\u6e7f\u6027\u7c89\u5242","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}