{"id":2436,"date":"2025-09-22T16:40:14","date_gmt":"2025-09-22T09:40:14","guid":{"rendered":"https:\/\/productregistrationindonesia.com\/?p=2436"},"modified":"2025-12-10T22:12:14","modified_gmt":"2025-12-10T15:12:14","slug":"indonesia-medical-device-registration-process-with-asean-csdt-cheat-sheet","status":"publish","type":"post","link":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/indonesia-medical-device-registration-process-with-asean-csdt-cheat-sheet\/","title":{"rendered":"\u4f7f\u7528\u4e1c\u76df CSDT \u5907\u5fd8\u5355\u638c\u63e1\u5370\u5ea6\u5c3c\u897f\u4e9a\u533b\u7597\u5668\u68b0\u6ce8\u518c\u6d41\u7a0b\uff1a\u7b80\u5316\u6863\u6848\u7f16\u5236\u5e76\u5c06\u5ba1\u6279\u65f6\u95f4\u7f29\u77ed\u6570\u5468"},"content":{"rendered":"<p>\u4e3a\u4e86\u534f\u8c03\u4e1c\u76df\u7684\u7533\u62a5\u5e76\u51cf\u5c11\u91cd\u590d\u5de5\u4f5c\uff0c\u4e1c\u76df\u533b\u7597\u5668\u68b0\u6307\u4ee4\u5f15\u5165\u4e86\u901a\u7528\u63d0\u4ea4\u6863\u6848\u6a21\u677f\uff08CSDT\uff09<strong>. <\/strong>\u5370\u5ea6\u5c3c\u897f\u4e9a\u536b\u751f\u90e8\u73b0\u5728\u63a5\u53d7\u5e76\u503e\u5411\u4e8e\u4f7f\u7528 CSDT \u5e03\u5c40\uff0c\u4f7f\u5176\u6210\u4e3a\u533b\u7597\u5668\u68b0\u6ce8\u518c\u8fc7\u7a0b\u4e2d\u6700\u5feb\u83b7\u5f97\u6863\u6848\u63a5\u53d7\u7684\u9014\u5f84\u3002<\/p>\n\n\n\n<p>\u901a\u8fc7\u4e0e CSDT 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\u662f\u9996\u9009\u683c\u5f0f\uff0c\u524d\u63d0\u662f\u60a8\u8865\u5145\u4efb\u4f55\u5370\u5ea6\u5c3c\u897f\u4e9a\u7279\u6709\u7684\u9879\u76ee\uff0c\u4f8b\u5982\u5f53\u5730\u6807\u7b7e\u8981\u6c42\u6216\u5370\u5c3c\u8bed\u7ffb\u8bd1\uff08<a href=\"https:\/\/regalkes.kemkes.go.id\/informasi_alkes\/Regulasi%20Lisensi%20Produk.pdf\" target=\"_blank\" rel=\"noopener\">Regalkes Kemenkes PDF<\/a>).<\/p>\n\n\n\n<p><strong>\u4ee5\u4e0b\u662f\u6709\u6548\u4f7f\u7528 CSDT \u7684\u65b9\u6cd5\uff1a<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>\u7ba1\u7406\u6570\u636e\n<ul class=\"wp-block-list\">\n<li>\u586b\u5199\u536b\u751f\u90e8\u6c42\u804c\u4fe1\u6a21\u677f\uff08\u4e0b\u8f7d\u5730\u5740\uff1a <a href=\"https:\/\/regalkes.kemkes.go.id\/\" target=\"_blank\" rel=\"noopener\">\u96f7\u52a0\u5c14\u514b\u65af<\/a> \u5730\u70b9\uff09\u3002<\/li>\n\n\n\n<li>\u4f7f\u7528 CSDT 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class=\"wp-block-list\">\n<li>\u5c06\u53f0\u67b6\u8bd5\u9a8c\u548c\u751f\u7269\u76f8\u5bb9\u6027\u8bd5\u9a8c\u6574\u7406\u5728\u4e00\u4e2a\u9644\u4ef6\u4e0b\u3002<\/li>\n\n\n\n<li>\u5c06\u5173\u952e\u5b89\u5168\u58f0\u660e\u7ffb\u8bd1\u6210\u5370\u5ea6\u5c3c\u897f\u4e9a\u8bed\u3002<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>\u6807\u7b7e\u548c\u4f7f\u7528\u8bf4\u660e\n<ul class=\"wp-block-list\">\n<li>\u6cd5\u89c4\u68c0\u67e5\uff1a\u786e\u4fdd\u60a8\u7684\u4ea7\u54c1\u6807\u7b7e\u7b26\u5408\u536b\u751f\u90e8\u6240\u6709\u73b0\u884c\u8981\u6c42\u3002\u8fd9\u5305\u62ec\u6240\u6709\u65b0\u89c4\uff0c\u4f8b\u5982\u6e05\u771f\u6807\u8bc6\uff08\u5982\u9002\u7528\u4e8e\u60a8\u7684\u5668\u68b0\u6750\u6599\uff09\u4ee5\u53ca\u6807\u7b7e\u4e0a\u7684\u7ecf\u9500\u5546\u4fe1\u606f\u3002\u5982\u679c\u7f3a\u5c11\u8fd9\u4e9b\u8be6\u7ec6\u4fe1\u606f\uff0c\u53ef\u80fd\u4f1a\u5bfc\u81f4\u8bc4\u4f30\u8fc7\u7a0b\u4e2d\u51fa\u73b0\u6700\u540e\u4e00\u523b\u7684\u66f4\u6b63\u6216\u88ab\u62d2\u7edd\u7684\u60c5\u51b5\u3002<\/li>\n\n\n\n<li>\u786e\u4fdd IFU \u5305\u542b\u5f53\u5730\u8bed\u8a00\u7684\u8bf4\u660e\u548c\u5904\u7f6e\u4fe1\u606f\u3002<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n\n\n\n<p>\u5c06\u5907\u5fd8\u5355\u6e05\u5355\u76f4\u63a5\u96c6\u6210\u5230 CSDT 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class=\"wp-block-list\">\n<li><strong>\u63d0\u4ea4\u524d\u5ba1\u6838\uff1a<\/strong> \u5728\u65b0\u52a0\u5761\uff0c\u5236\u9020\u5546\u4f1a\u8fdb\u884c\u5185\u90e8\u201c\u6a21\u62df\u5ba1\u67e5\u201d\uff0c\u4ee5\u4fbf\u53ca\u65e9\u53d1\u73b0\u5dee\u8ddd\u3002\u5728\u5370\u5ea6\u5c3c\u897f\u4e9a\u4e5f\u5e94\u91c7\u53d6\u540c\u6837\u7684\u63aa\u65bd\u2014\u2014\u786e\u8ba4\u60a8\u7684\u6863\u6848\u6309\u7167 CSDT \u7684\u51c6\u786e\u987a\u5e8f\u7f16\u5236\uff0c\u5e76\u4e14\u6240\u6709\u5fc5\u9700\u90e8\u5206\u5747\u5df2\u5305\u542b\u3002\u63d0\u4ea4\u524d\uff0c\u8bf7\u68c0\u67e5\u662f\u5426\u5b58\u5728\u4efb\u4f55\u4e0d\u4e00\u81f4\u6216\u7f3a\u5931\u7684\u5185\u5bb9\uff08\u4f8b\u5982\uff0c\u672a\u7ffb\u8bd1\u7684\u6587\u672c\u3001\u8fc7\u65f6\u7684\u6d4b\u8bd5\u6570\u636e\uff09\u3002<\/li>\n\n\n\n<li><strong>\u5e73\u884c\u7ffb\u8bd1\uff1a<\/strong> \u9a6c\u6765\u897f\u4e9a\u51fa\u53e3\u5546\u5728\u8d77\u8349\u82f1\u6587\u6587\u4ef6\u7684\u540c\u65f6\uff0c\u8fd8\u5c06\u6587\u4ef6\u7ffb\u8bd1\u6210\u9a6c\u6765\u8bed\uff0c\u5bf9\u9a6c\u6765\u8bed\u4e5f\u91c7\u53d6\u540c\u6837\u7684\u65b9\u6cd5\u3002<\/li>\n\n\n\n<li><strong>\u4e13\u804c\u534f\u8c03\u5458\uff1a<\/strong> \u6cf0\u56fd\u9876\u7ea7\u516c\u53f8\u6307\u6d3e\u4e00\u540d\u4e13\u5bb6\u6765\u7ba1\u7406\u7248\u672c\u63a7\u5236\uff0c\u9632\u6b62\u66f4\u65b0\u51b2\u7a81\u3002<\/li>\n<\/ul>\n\n\n\n<p>\u901a\u8fc7\u91c7\u7528\u8fd9\u4e9b\u65b9\u6cd5\uff0c\u60a8\u53ef\u4ee5\u6700\u5927\u9650\u5ea6\u5730\u51cf\u5c11\u5ba1\u7a3f\u4eba\u7684\u95ee\u9898\uff0c\u907f\u514d\u540e\u671f\u4fee\u6539\uff0c\u5e76\u8fbe\u5230 <a href=\"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/medical-device-registration-in-indonesia-nie-risk-classes-regulatory-strategy\/\">NIE \u6279\u51c6<\/a> \u53ea\u9700\u51e0\u5468\u800c\u4e0d\u662f\u51e0\u4e2a\u6708\u7684\u65f6\u95f4\u3002<\/p>\n\n\n\n<p>\u5370\u5c3c\u7684\u76d1\u7ba1\u683c\u5c40\u77ac\u606f\u4e07\u53d8\uff0c\u800c CSDT \u662f\u60a8\u4fdd\u6301\u9886\u5148\u7684\u79d8\u8bc0\u3002\u56f4\u7ed5 CSDT \u6784\u5efa\u60a8\u7684\u6863\u6848\uff0c\u4e0d\u4ec5\u53ef\u4ee5\u4e0e\u4e1c\u76df\u540c\u884c\u534f\u8c03\u4e00\u81f4\uff0c\u8fd8\u80fd\u5927\u5e45\u7f29\u77ed\u5ba1\u6838\u5468\u671f\u548c\u53cd\u590d\u6c9f\u901a\u3002<\/p>\n\n\n\n<p>\u901a\u8fc7\u4e0e <a href=\"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\"><strong>ProductRegistrationIndonesia.com<\/strong>,<\/a> \u6211\u4eec\u53ef\u4ee5\u5e2e\u52a9\u60a8\u4f7f\u7528\u6700\u65b0\u7684 CSDT \u6307\u5357\u4ee5\u53ca\u5370\u5ea6\u5c3c\u897f\u4e9a\u7279\u5b9a\u7684\u9644\u5f55\uff0c\u5305\u62ec\u63d0\u4f9b\u5370\u5c3c\u8bed\u6587\u4ef6\uff0c\u4ee5\u907f\u514d\u8bef\u89e3\uff0c\u5e76\u7531\u6211\u4eec\u7684\u4e13\u5bb6\u56e2\u961f\u63d0\u4f9b OSS \u95e8\u6237\u652f\u6301\u3002<\/p>\n\n\n\n<p>\u4fdd\u6301\u5bf9\u6587\u4ef6\u8d28\u91cf\u7684\u8b66\u60d5\u2014\u2014\u4ece\u6709\u6548\u7684\u8bc1\u4e66\u5230\u51c6\u786e\u7684\u7ffb\u8bd1\u2014\u2014\u4e0e\u9075\u5faa CSDT \u683c\u5f0f\u540c\u6837\u91cd\u8981\u3002\u901a\u8fc7\u6b63\u786e\u7684\u51c6\u5907\u548c\u4e13\u5bb6\u6307\u5bfc\uff0c\u60a8\u53ef\u4ee5\u907f\u514d\u5e38\u89c1\u7684\u9677\u9631\uff0c\u5e76\u66f4\u5feb\u5730\u83b7\u5f97\u5ba1\u6279\u3002<\/p>","protected":false},"excerpt":{"rendered":"<p>To harmonize ASEAN filings and reduce redundant work, the ASEAN Medical Device Directive introduced the Common Submission Dossier Template (CSDT). Indonesia\u2019s Ministry of Health now accepts and prefers the CSDT layout, making it your fastest route to dossier acceptance in the medical device registration process. By aligning with the CSDT, you speak the same regulatory [&hellip;]<\/p>\n","protected":false},"author":7,"featured_media":2437,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[45],"tags":[],"country":[],"class_list":["post-2436","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-device-articles"],"acf":[],"_links":{"self":[{"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts\/2436","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/comments?post=2436"}],"version-history":[{"count":3,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts\/2436\/revisions"}],"predecessor-version":[{"id":4099,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts\/2436\/revisions\/4099"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/media\/2437"}],"wp:attachment":[{"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/media?parent=2436"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/categories?post=2436"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/tags?post=2436"},{"taxonomy":"country","embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/country?post=2436"}],"curies":[{"name":"\u53ef\u6e7f\u6027\u7c89\u5242","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}