{"id":5922,"date":"2026-05-05T10:11:00","date_gmt":"2026-05-05T03:11:00","guid":{"rendered":"https:\/\/productregistrationindonesia.com\/"},"modified":"2026-07-15T21:25:18","modified_gmt":"2026-07-15T14:25:18","slug":"ivd-registration-indonesia","status":"publish","type":"post","link":"https:\/\/productregistrationindonesia.com\/zh\/ivd-registration-indonesia\/","title":{"rendered":"\u5370\u5c3c\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u6ce8\u518c\uff1a\u6b27\u7f8e\u54c1\u724c\u7684\u7ec8\u6781\u6307\u5357"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u5370\u5c3c\u7684\u8bca\u65ad\u5e02\u573a\u6b63\u5728\u5feb\u901f\u589e\u957f\uff0c\u73b0\u5728\u8fdb\u5165\u8be5\u5e02\u573a\u7684\u5916\u56fd\u54c1\u724c\u6709\u671b\u5360\u636e\u91cd\u8981\u4efd\u989d\u3002\u4f46\u6253\u5165\u8fd9\u4e2a\u5e02\u573a\u5e76\u975e\u4ec5\u4ec5\u62e5\u6709\u4e16\u754c\u4e00\u6d41\u7684\u4ea7\u54c1\u5c31\u80fd\u5b9e\u73b0\u3002.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5bf9\u4e8e\u4efb\u4f55\u5411\u5370\u5c3c\u5e02\u573a\u51fa\u53e3\u8bca\u65ad\u8bd5\u5242\u76d2\u3001\u8bd5\u5242\u6216\u5206\u6790\u4eea\u7684\u7f8e\u56fd\u6216\u6b27\u6d32\u5236\u9020\u5546\u800c\u8a00\uff0c\u5728\u5370\u5c3c\u8fdb\u884c\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u6ce8\u518c\u662f\u4e00\u4e2a\u4e0d\u5bb9\u5546\u69b7\u7684\u76d1\u7ba1\u91cc\u7a0b\u7891\uff0c\u9700\u8981\u7cbe\u5fc3\u51c6\u5907\u3001\u6b63\u786e\u7684\u6587\u6863\u548c\u503c\u5f97\u4fe1\u8d56\u7684\u5f53\u5730\u5408\u4f5c\u4f19\u4f34\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u653f\u5e9c\u5927\u529b\u52a0\u5f3a\u8bca\u65ad\u57fa\u7840\u8bbe\u65bd\u5efa\u8bbe\uff0c\u5c24\u5176\u662f\u5728\u75ab\u60c5\u4e4b\u540e\uff0c\u4e3a\u6765\u81ea\u6210\u719f\u56fd\u9645\u5e02\u573a\u7684\u9ad8\u8d28\u91cf\u4f53\u5916\u8bca\u65ad\u4ea7\u54c1\u521b\u9020\u4e86\u771f\u6b63\u7684\u5546\u4e1a\u673a\u4f1a\u3002.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u7136\u800c\uff0c\u8bb8\u591a\u5916\u56fd\u5236\u9020\u5546\u51c6\u5907\u4e0d\u8db3\uff0c\u4f4e\u4f30\u4e86\u5370\u5c3c\u76d1\u7ba1\u73af\u5883\u4e0e\u6b27\u76df\u6216\u7f8e\u56fd\u4e4b\u95f4\u7684\u5dee\u5f02\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u672c\u6307\u5357\u8be6\u7ec6\u4ecb\u7ecd\u4e86\u5916\u56fd\u54c1\u724c\u9700\u8981\u4e86\u89e3\u7684\u4e00\u5207\uff1a\u98ce\u9669\u5206\u7c7b\u3001\u5b9e\u9a8c\u5ba4\u6d4b\u8bd5\u8981\u6c42\u3001\u6280\u672f\u6587\u6863 (CSDT) \u4ee5\u53ca\u76f8\u5173\u7684\u5370\u5c3c\u6cd5\u89c4\u3002.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u4e3a\u4ec0\u4e48\u5370\u5c3c\u662f\u4f53\u5916\u8bca\u65ad\u54c1\u724c\u7684\u4f18\u5148\u5e02\u573a\uff1f<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e1c\u5357\u4e9a\u6700\u5927\u7684\u7ecf\u6d4e\u4f53\u7ee7\u7eed\u5927\u529b\u6295\u8d44\u5176\u533b\u7597\u4fdd\u5065\u7cfb\u7edf\u3002\u5728\u5370\u5c3c\u653f\u5e9c\u7684JKN\uff08\u5168\u6c11\u533b\u7597\u4fdd\u5065\u8ba1\u5212\uff09\u4e0b\uff0c<a href=\"https:\/\/bpjs-kesehatan.go.id\/#\/\" target=\"_blank\" rel=\"noopener\">\u56fd\u6c11\u5065\u5eb7\u5c40<\/a>\u5728\u5168\u6c11\u5065\u5eb7\u8986\u76d6\u8ba1\u5212\u4e0b\uff0c\u533b\u9662\u548c\u57fa\u5c42\u8bca\u6240\u5bf9\u4ef7\u683c\u5408\u7406\u3001\u53ef\u9760\u7684\u8bca\u65ad\u5de5\u5177\u7684\u9700\u6c42\u6fc0\u589e\u3002.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8fd9\u63a8\u52a8\u4e86\u4ece\u7b80\u5355\u7684\u8840\u7cd6\u4eea\u5230\u590d\u6742\u7684\u5206\u5b50\u8bca\u65ad\u5e73\u53f0\u7b49\u5404\u7c7b\u4ea7\u54c1\u7684\u5e7f\u6cdb\u91c7\u8d2d\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5bf9\u4e8e\u6b27\u7f8e\u4f53\u5916\u8bca\u65ad\uff08IVD\uff09\u516c\u53f8\u800c\u8a00\uff0c\u8fd9\u79cd\u9700\u6c42\u4fe1\u53f7\u6781\u5177\u5438\u5f15\u529b\u3002\u4f46\u8981\u8fdb\u5165\u8be5\u5e02\u573a\uff0c\u9700\u8981\u4e0e\u4e24\u4e2a\u5173\u952e\u90e8\u95e8\u6253\u4ea4\u9053\uff1a\u536b\u751f\u90e8\uff08Kementerian Kesehatan\uff0c\u6216\u79f0\u653f\u5e9c\u90e8\u95e8\u6216\u673a\u6784\uff09\u3002 <a href=\"https:\/\/kemkes.go.id\/id\/home\" target=\"_blank\" rel=\"noopener\">\u51ef\u95e8\u514b\u65af<\/a>\uff09\uff0c\u8d1f\u8d23\u76d1\u7ba1\u533b\u7597\u5668\u68b0\u6ce8\u518c\u7cfb\u7edf\uff0c\u4ee5\u53ca\u56fd\u5bb6\u836f\u54c1\u548c\u98df\u54c1\u63a7\u5236\u5c40\uff08Badan Pengawas Obat dan Makanan\uff0c\u901a\u5e38\u79f0\u4e3a <a href=\"https:\/\/www.pom.go.id\/\" target=\"_blank\" rel=\"noopener\">\u4e1a\u52a1\u6d41\u7a0b\u5bf9\u8c61\u6a21\u578b<\/a>\uff09\uff0c\u5b83\u53d1\u6325\u7740\u8f85\u52a9\u76d1\u7763\u4f5c\u7528\uff0c\u5c24\u5176\u662f\u5728\u6d89\u53ca\u8bd5\u5242\u5316\u5b66\u548c\u751f\u7269\u7269\u8d28\u7684\u9886\u57df\u3002.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>\u91cd\u8981\u76d1\u7ba1\u8bf4\u660e<\/strong>\u5728\u5370\u5ea6\u5c3c\u897f\u4e9a\uff0c\u6240\u6709\u533b\u7597\u5668\u68b0\uff0c\u5305\u62ec\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\uff08IVD\uff09\uff0c\u90fd\u5fc5\u987b\u83b7\u5f97\u7531\u5370\u5c3c\u536b\u751f\u3001\u80fd\u6e90\u548c\u6d88\u8d39\u54c1\u90e8\uff08KEMENKES\uff09\u9881\u53d1\u7684\u5b98\u65b9\u4ea7\u54c1\u6ce8\u518c\u53f7\uff08NIE\uff09\u3002\u6839\u636e\u5370\u5c3c\u6cd5\u5f8b\uff0c\u6ca1\u6709NIE\uff0c\u8fdb\u53e3\u6216\u5206\u9500\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u4ea7\u54c1\u662f\u8fdd\u6cd5\u7684\u3002.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u5370\u5c3c\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u98ce\u9669\u5206\u7c7b\uff1aA\u81f3D\u7ea7<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u5370\u5ea6\u5c3c\u897f\u4e9a\u5c06\u5176\u533b\u7597\u5668\u68b0\u548c IVD \u5206\u7c7b\u7cfb\u7edf\u5e7f\u6cdb\u5730\u4e0e\u4e1c\u76df\u533b\u7597\u5668\u68b0\u6307\u4ee4 (AMDD) \u548c\u4e1c\u76df\u534f\u8c03\u6307\u5357\u4fdd\u6301\u4e00\u81f4\u3002\u6839\u636e Peraturan Menteri Kesehatan Nomor 62 Tahun 2017 tentang Izin Edar Alat Kesehatan\u3001\u4f53\u5916\u8bca\u65ad\u548c Perbekalan Kesehatan Rumah Tangga\uff0cIVD \u5206\u4e3a\u56db\u4e2a\u98ce\u9669\u7c7b\u522b\uff0c\u6bcf\u4e2a\u98ce\u9669\u7c7b\u522b\u90fd\u6709\u4e0d\u540c\u7684\u76d1\u7ba1\u8981\u6c42\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>A\u7c7b\uff1a\u4f4e\u98ce\u9669<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">A\u7c7b\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u5bf9\u4e2a\u4eba\u6216\u516c\u4f17\u7684\u98ce\u9669\u6781\u4f4e\u3002\u4f8b\u5982\uff0c\u7b80\u6613\u8840\u7cd6\u8bd5\u7eb8\u548c\u901a\u7528\u5c3f\u6db2\u68c0\u6d4b\u8bd5\u5242\u76d2\u7b49\u4ea7\u54c1\u5c31\u5c5e\u4e8e\u6b64\u7c7b\u3002A\u7c7b\u4ea7\u54c1\u7684\u6ce8\u518c\u6d41\u7a0b\u8f83\u4e3a\u7b80\u5316\uff1a\u5236\u9020\u5546\u53ef\u80fd\u7b26\u5408\u81ea\u6211\u58f0\u660e\u9014\u5f84\uff08Pernyataan Mandiri\uff09\u7684\u6761\u4ef6\uff0c\u8fd9\u53ef\u4ee5\u663e\u8457\u51cf\u5c11\u6587\u4ef6\u8d1f\u62c5\u548c\u65f6\u95f4\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>B\u7c7b\uff1a\u4f4e\u81f3\u4e2d\u7b49\u98ce\u9669<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u8840\u6db2\u5206\u6790\u4eea\u548c\u6807\u51c6\u751f\u5316\u68c0\u6d4b\u8bd5\u5242\u76d2\u7b49\u4ea7\u54c1\u901a\u5e38\u5c5e\u4e8eB\u7c7b\u4ea7\u54c1\u3002\u6b64\u7c7b\u4ea7\u54c1\u9700\u8981\u63d0\u4ea4\u7b80\u5316\u7684\u8d44\u6599\uff0c\u5e76\u7531\u82ac\u5170\u56fd\u5bb6\u836f\u54c1\u548c\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u5c40\uff08KEMENKES\uff09\u8fdb\u884c\u6b63\u5f0f\u5ba1\u6838\u3002\u662f\u5426\u9700\u8981\u8fdb\u884c\u5b9e\u9a8c\u5ba4\u68c0\u6d4b\u53d6\u51b3\u4e8e\u5177\u4f53\u4ea7\u54c1\u53ca\u5176\u9884\u671f\u7528\u9014\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>C\u7ea7\uff1a\u4e2d\u9ad8\u98ce\u9669<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u8840\u5e93\u7b5b\u67e5\u8bd5\u5242\u3001\u5206\u5b50\u8bca\u65ad\u8bd5\u5242\u76d2\u548c\u6162\u6027\u75c5\u6807\u5fd7\u7269\u68c0\u6d4b\u901a\u5e38\u5c5e\u4e8eC\u7c7b\u3002\u6b64\u7c7b\u4ea7\u54c1\u9700\u8981\u63d0\u4ea4\u5b8c\u6574\u7684CSDT\uff08\u901a\u7528\u7533\u62a5\u8d44\u6599\u6a21\u677f\uff09\uff0c\u5e76\u63d0\u4f9b\u6027\u80fd\u8bc1\u660e\uff0c\u5305\u62ec\u5206\u6790\u9a8c\u8bc1\u6570\u636e\u3002\u5fc5\u987b\u5728\u7ecf\u8ba4\u8bc1\u7684\u5b9e\u9a8c\u5ba4\u8fdb\u884c\u68c0\u6d4b\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>D\u7c7b\uff1a\u9ad8\u98ce\u9669<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">D\u7c7b\u4ea7\u54c1\u6db5\u76d6\u7528\u4e8e\u7b5b\u67e5\u5371\u53ca\u751f\u547d\u7684\u4f20\u67d3\u75c5\uff08\u5305\u62ec\u827e\u6ecb\u75c5\u6bd2\u3001\u4e59\u578b\u809d\u708e\u548c\u4e19\u578b\u809d\u708e\u4ee5\u53ca\u8840\u578b\u7cfb\u7edf\uff09\u7684\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u3002\u8fd9\u7c7b\u4ea7\u54c1\u9700\u6ee1\u8db3\u6700\u9ad8\u7684\u8bc1\u636e\u8981\u6c42\uff1a\u5b8c\u6574\u7684CSDT\u6863\u6848\u3001\u53ef\u9760\u7684\u4e34\u5e8a\u6027\u80fd\u6570\u636e\uff0c\u4ee5\u53ca\u5fc5\u987b\u6309\u7167\u5370\u5c3c\u56fd\u5bb6\u6807\u51c6\uff08SNI\uff09\u6216\u540c\u7b49ISO\u6807\u51c6\u8fdb\u884c\u7684\u5f3a\u5236\u6027\u6d4b\u8bd5\u3002\u4ece\u63d0\u4ea4\u7533\u8bf7\u5230\u83b7\u5f97\u6279\u51c6\uff0c\u901a\u5e38\u9700\u898112-18\u4e2a\u6708\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u98ce\u9669\u7b49\u7ea7\u5bf9\u6bd4\u6982\u89c8<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e0b\u8868\u603b\u7ed3\u4e86 IVD \u7684\u56db\u4e2a\u98ce\u9669\u7b49\u7ea7\u3001\u5176\u4ee3\u8868\u6027\u4ea7\u54c1\u7c7b\u522b\u3001\u76d1\u7ba1\u9014\u5f84\u3001\u6307\u793a\u6027\u65f6\u95f4\u8868\u548c\u5b9e\u9a8c\u5ba4\u6d4b\u8bd5\u4e49\u52a1\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5bf9\u4e8e\u6b63\u5728\u8bc4\u4f30\u5176\u4ea7\u54c1\u662f\u5426\u9700\u8981\u5b8c\u6574\u7684\u4f53\u5916\u8bca\u65ad BPOM \u6587\u4ef6\u6216\u91c7\u7528\u66f4\u7b80\u4fbf\u65b9\u6cd5\u7684\u54c1\u724c\u6765\u8bf4\uff0c\u8fd9\u4e00\u70b9\u5c24\u5176\u91cd\u8981\u3002.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>\u73ed\u7ea7<\/strong><\/td><td><strong>\u793a\u4f8b<\/strong><\/td><td><strong>\u6ce8\u518c\u8def\u5f84<\/strong><\/td><td><strong>\u65f6\u95f4\u7ebf<\/strong><\/td><td><strong>\u5b9e\u9a8c\u5ba4\u6d4b\u8bd5<\/strong><\/td><\/tr><tr><td>A\uff08\u4f4e\u98ce\u9669\uff09<\/td><td>\u4e2a\u4eba\u8840\u7cd6\u4eea\u3001\u9a8c\u5b55\u68d2<\/td><td>\u81ea\u6211\u58f0\u660e (Pernyataan Mandiri)<\/td><td>3-6\u4e2a\u6708<\/td><td>\u65e0\u9700<\/td><\/tr><tr><td>B\uff08\u4f4e-\u4e2d\uff09<\/td><td>\u8840\u6db2\u5206\u6790\u4eea\u3001\u666e\u901a\u5316\u5b66\u6d4b\u8bd5<\/td><td>\u7b80\u5316\u6863\u6848 + BPOM \u5ba1\u6838<\/td><td>6-9\u4e2a\u6708<\/td><td>\u6709\u65f6\u9700\u8981<\/td><\/tr><tr><td>C\uff08\u4e2d\u9ad8\uff09<\/td><td>\u8840\u5e93\u7b5b\u67e5\u8bd5\u5242\u3001\u5206\u5b50\u8bca\u65ad<\/td><td>\u5b8c\u6574\u7684CSDT\u6863\u6848+\u5b9e\u9a8c\u5ba4\u8bc1\u636e<\/td><td>9-15\u4e2a\u6708<\/td><td>\u5fc5\u9700\u7684<\/td><\/tr><tr><td>D\uff08\u9ad8\u98ce\u9669\uff09<\/td><td>\u827e\u6ecb\u75c5\u6bd2\u3001\u809d\u708e\u7b5b\u67e5\u8bd5\u5242\u76d2\u3001\u8840\u578b\u9274\u5b9a<\/td><td>\u5b8c\u6574\u7684CSDT + \u4e34\u5e8a\/\u6027\u80fd\u6570\u636e<\/td><td>12-18\u4e2a\u6708<\/td><td>\u5f3a\u5236\u6027\uff08SNI\/ISO\uff09<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\u6ce8\uff1a\u65f6\u95f4\u5b89\u6392\u4ec5\u4f9b\u53c2\u8003\uff0c\u5b9e\u9645\u65f6\u95f4\u53ef\u80fd\u56e0\u80af\u5c3c\u4e9a\u6559\u80b2\u3001\u7a0e\u52a1\u548c\u6280\u80fd\u90e8 (KEMENKES) \u7684\u5de5\u4f5c\u91cf\u3001\u63d0\u4ea4\u6750\u6599\u7684\u5b8c\u6574\u6027\u4ee5\u53ca\u4efb\u4f55\u5176\u4ed6\u6570\u636e\u8981\u6c42\u800c\u6709\u6240\u4e0d\u540c\u3002\u8058\u8bf7\u4e13\u4e1a\u7684\u672c\u5730\u5408\u4f5c\u4f19\u4f34\u901a\u5e38\u53ef\u4ee5\u663e\u8457\u7f29\u77ed\u65f6\u95f4\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u4f53\u5916\u8bca\u65ad\u4ea7\u54c1\u7684\u5b9e\u9a8c\u5ba4\u68c0\u6d4b\u8981\u6c42<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u5728\u4ee5\u4e0b\u73af\u8282\u4e2d\uff0c\u6700\u5e38\u88ab\u4f4e\u4f30\u7684\u6b65\u9aa4\u4e4b\u4e00\u662f\uff1a <a href=\"https:\/\/productregistrationindonesia.com\/zh\/services\/medical-device-registration-indonesia\/\">\u5370\u5c3c\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u6ce8\u518c\u6d41\u7a0b<\/a> \u662f\u5b9e\u9a8c\u5ba4\u68c0\u6d4b\u3002.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e0e\u5176\u4ed6\u4e00\u4e9b\u5e02\u573a\u53ea\u9700\u7b2c\u4e09\u56fd\u4e34\u5e8a\u6570\u636e\u5373\u53ef\uff0c\u5370\u5c3c\u76d1\u7ba1\u673a\u6784\u901a\u5e38\u8981\u6c42\u5728\u5f53\u5730\u8ba4\u53ef\u6216\u83b7\u5f97 ISO 17025 \u8ba4\u8bc1\u7684\u673a\u6784\u8fdb\u884c\u6027\u80fd\u6d4b\u8bd5\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5bf9\u4e8eC\u7c7b\u548cD\u7c7b\u4ea7\u54c1\uff0c\u6d4b\u8bd5\u8303\u56f4\u901a\u5e38\u5305\u62ec\uff1a<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u5f53\u5730\u6761\u4ef6\u4e0b\u7684\u5206\u6790\u7075\u654f\u5ea6\u548c\u7279\u5f02\u6027<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u4e0e\u5f53\u5730\u76f8\u5173\u5e72\u6270\u7269\u8d28\u8fdb\u884c\u4ea4\u53c9\u53cd\u5e94\u6027\u6d4b\u8bd5<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u7cbe\u786e\u5ea6\u548c\u53ef\u91cd\u590d\u6027\uff08\u6279\u5185\u548c\u6279\u95f4\uff09<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u5728\u5370\u5c3c\u6c14\u5019\u6761\u4ef6\uff08\u6e29\u5ea6\u3001\u6e7f\u5ea6\uff09\u4e0b\u7684\u7a33\u5b9a\u6027\u6d4b\u8bd5<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u4e0e\u5df2\u5efa\u7acb\u7684\u91d1\u6807\u51c6\u65b9\u6cd5\u8fdb\u884c\u6bd4\u8f83\u7684\u4e34\u5e8a\u6027\u80fd<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5236\u9020\u5546\u5e94\u5728\u751f\u4ea7\u6d41\u7a0b\u65e9\u671f\u5c31\u89c4\u5212\u597d\u5b9e\u9a8c\u5ba4\u68c0\u6d4b\u4e8b\u5b9c\u3002\u627e\u5230\u4e00\u5bb6\u80fd\u591f\u5904\u7406\u5176\u7279\u5b9a\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u7c7b\u522b\u7684\u8ba4\u8bc1\u5b9e\u9a8c\u5ba4\u5e76\u975e\u6613\u4e8b\uff0c\u67d0\u4e9b\u7c7b\u522b\u7684\u68c0\u6d4b\u8fd8\u9700\u8981\u4e0e\u6559\u5b66\u533b\u9662\u6216\u56fd\u5bb6\u7ea7\u53c2\u8003\u5b9e\u9a8c\u5ba4\u534f\u8c03\u5408\u4f5c\u3002.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>\u7ed9\u5916\u56fd\u54c1\u724c\u7684\u5b9e\u7528\u5efa\u8bae<\/strong>\u5b9e\u9a8c\u5ba4\u8ba4\u8bc1\u548c\u6d4b\u8bd5\u8ba1\u5212\u5e94\u81f3\u5c11\u5728\u8ba1\u5212\u63d0\u4ea4\u65e5\u671f\u524d\u516d\u4e2a\u6708\u5f00\u59cb\u3002\u6d4b\u8bd5\u5931\u8d25\u6216\u65b9\u6848\u4e0d\u7b26\u662f\u5bfc\u81f4\u6ce8\u518c\u5ef6\u8bef\u7684\u4e3b\u8981\u539f\u56e0\u4e4b\u4e00\u3002\u4e00\u4f4d\u719f\u6089\u5370\u5c3c\u5b9e\u9a8c\u5ba4\u8981\u6c42\u7684\u5f53\u5730\u76d1\u7ba1\u987e\u95ee\u5728\u6b64\u81f3\u5173\u91cd\u8981\u3002.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u7406\u89e3\u6280\u672f\u6587\u6863\uff1aCSDT<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u901a\u7528\u63d0\u4ea4\u6587\u4ef6\u6a21\u677f (CSDT) \u662f\u4e1c\u76df\u7edf\u4e00\u7684\u6280\u672f\u6587\u4ef6\u683c\u5f0f\uff0c\u9002\u7528\u4e8e\u5370\u5ea6\u5c3c\u897f\u4e9a\u7684 C \u7c7b\u548c D \u7c7b\u4f53\u5916\u8bca\u65ad\u533b\u7597\u5668\u68b0 (IVD) \u63d0\u4ea4\u3002.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e60\u60ef\u4e8e\u6b27\u76df IVDR \u6280\u672f\u6587\u4ef6\u6216 FDA 510(k) \u7533\u62a5\u7684\u7f8e\u56fd\u548c\u6b27\u6d32\u5236\u9020\u5546\u4f1a\u53d1\u73b0 CSDT \u7ed3\u6784\u6709\u4e9b\u719f\u6089\uff0c\u4f46\u4e5f\u5b58\u5728\u91cd\u8981\u7684\u533a\u57df\u5dee\u5f02\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5370\u5c3c\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u6ce8\u518c\u7684\u5b8c\u6574CSDT\u5305\u62ec\u4ee5\u4e0b\u6838\u5fc3\u90e8\u5206\uff1a<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u7b2c\u4e00\u90e8\u5206\uff1a\u8bbe\u5907\u63cf\u8ff0\u548c\u89c4\u683c\uff08\u5305\u62ec\u9884\u671f\u7528\u9014\u3001\u5de5\u4f5c\u539f\u7406\u548c\u6807\u7b7e\uff09<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u7b2c\u4e8c\u90e8\u5206\uff1a\u8bbe\u8ba1\u9a8c\u8bc1\u548c\u786e\u8ba4\uff08\u5305\u62ec\u8bbe\u8ba1\u5386\u53f2\u3001\u6d4b\u8bd5\u89c4\u7a0b\u548c\u9a8c\u8bc1\u8bc1\u636e\uff09<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u7b2c 3 \u90e8\u5206\uff1a\u751f\u4ea7\u4fe1\u606f\uff08\u8bbe\u65bd\u8be6\u60c5\u3001\u8d28\u91cf\u4f53\u7cfb\u8ba4\u8bc1\u3001ISO 13485 \u8303\u56f4\uff09<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u7b2c 4 \u90e8\u5206\uff1a\u4e34\u5e8a\/\u6027\u80fd\u8bc1\u636e\uff08\u5206\u6790\u6570\u636e\uff0c\u4ee5\u53ca D \u7c7b\u836f\u7269\u7684\u4e34\u5e8a\u6027\u80fd\u6570\u636e\uff09<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u7b2c 5 \u90e8\u5206\uff1a\u98ce\u9669\u7ba1\u7406\uff08ISO 14971 \u98ce\u9669\u7ba1\u7406\u6587\u4ef6\u6458\u8981\uff09<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u7b2c 6 \u90e8\u5206\uff1a\u4e0a\u5e02\u540e\u76d1\u6d4b\u8ba1\u5212\uff08\u8b66\u6212\u7cfb\u7edf\u548c\u4e0d\u826f\u4e8b\u4ef6\u62a5\u544a\u89c4\u7a0b\uff09<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5bf9\u4e8e\u5916\u56fd\u54c1\u724c\u6765\u8bf4\uff0c\u4e00\u4e2a\u5173\u952e\u7684\u533a\u522b\u662f\uff1a\u63d0\u4ea4\u7ed9 KEMENKES \u7684\u6240\u6709\u6587\u4ef6\u5fc5\u987b\u4f7f\u7528\u5370\u5c3c\u8bed\uff0c\u6216\u8005\u9644\u6709\u7ecf\u8ba4\u8bc1\u7684\u7ffb\u8bd1\u4ef6\u3002.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6b64\u9879\u8981\u6c42\u6db5\u76d6\u6807\u7b7e\u3001\u4f7f\u7528\u8bf4\u660e (IFU) \u548c\u5173\u952e\u6280\u672f\u7ae0\u8282\u3002\u672a\u80fd\u63d0\u4f9b\u7b26\u5408\u8981\u6c42\u7684\u7ffb\u8bd1\u662f\u7533\u8bf7\u88ab\u62d2\u7684\u5e38\u89c1\u539f\u56e0\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u5370\u5c3c\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u6ce8\u518c\u7684\u5173\u952e\u6cd5\u89c4<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u5728\u63d0\u4ea4\u4efb\u4f55\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\uff08IVD\uff09\u6ce8\u518c\u7533\u8bf7\u4e4b\u524d\uff0c\u4e86\u89e3\u76d1\u7ba1\u6846\u67b6\u81f3\u5173\u91cd\u8981\u3002\u4ee5\u4e0b\u6cd5\u89c4\u7ba1\u8f96\u5370\u5ea6\u5c3c\u897f\u4e9a\u7684\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u6ce8\u518c\u3001\u8fdb\u53e3\u548c\u5206\u9500\uff1a<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 2017 \u5e74\u7b2c 62 \u53f7\u536b\u751f\u90e8\u957f\u6761\u4f8b\uff1a\u8be5\u6761\u4f8b\u662f\u533b\u7597\u5668\u68b0\u3001\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u548c\u5bb6\u7528\u4fdd\u5065\u7528\u54c1\u4e0a\u5e02\u8bb8\u53ef\uff08Izin Edar\uff09\u9881\u53d1\u7684\u4e3b\u8981\u6cd5\u89c4\u3002\u8be5\u6761\u4f8b\u89c4\u5b9a\u4e86\u5206\u7c7b\u4f53\u7cfb\u3001\u7533\u8bf7\u7a0b\u5e8f\u548c\u4e0a\u5e02\u540e\u4e49\u52a1\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 Peraturan Menteri Kesehatan No. 26 Tahun 2018: \u7ba1\u7406\u533b\u7597\u5668\u68b0\u5206\u9500\u5546 (IPAK)\u3001\u8fdb\u53e3\u5546\u548c\u5236\u9020\u5546\u7684\u8bb8\u53ef\uff0c\u786e\u7acb\u4e86\u8c01\u53ef\u4ee5\u63d0\u4ea4\u7533\u8bf7\u7684\u6cd5\u5f8b\u6846\u67b6\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 2021 \u5e74\u7b2c 14 \u53f7\u536b\u751f\u90e8\u957f\u6761\u4f8b\uff1a\u89c4\u5b9a\u4e86\u7535\u5b50\u63d0\u4ea4\u7a0b\u5e8f\uff08\u7535\u5b50\u6ce8\u518c\uff09\uff0c\u7b80\u5316\u4e86\u6ce8\u518c\u4ea7\u54c1\u7533\u8bf7\u6d41\u7a0b\u7684\u90e8\u5206\u5185\u5bb9\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 2017 \u5e74\u7b2c 24 \u53f7 BPOM \u6761\u4f8b\uff1a\u4e0e\u4f53\u5916\u8bca\u65ad BPOM \u76d1\u7ba1\u76f8\u5173\uff0c\u7279\u522b\u662f\u4e0e\u836f\u54c1\u76f8\u5173\u7684\u751f\u7269\u8bd5\u5242\u548c\u8bca\u65ad\u8bd5\u5242\u76d2\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 SNI\uff08\u5370\u5c3c\u56fd\u5bb6\u6807\u51c6\uff09\uff1a\u9002\u7528\u4e8e\u7279\u5b9a\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u7c7b\u522b\uff08\u5c24\u5176\u662fD\u7c7b\u4ea7\u54c1\uff09\u7684\u5370\u5c3c\u56fd\u5bb6\u6807\u51c6\u3002\u5b9e\u9a8c\u5ba4\u68c0\u6d4b\u548c\u4ea7\u54c1\u8ba4\u8bc1\u53ef\u80fd\u9700\u8981\u7b26\u5408\u8fd9\u4e9b\u6807\u51c6\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u7ed3\u8bed\uff1a\u4e0e\u6211\u4eec\u4e00\u8d77\u63a2\u7d22\u60a8\u7684\u6210\u529f\u4e4b\u8def<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5728\u5370\u5c3c\u6210\u529f\u83b7\u5f97\u4f53\u5916\u8bca\u65ad\u8bd5\u5242 (IVD) \u6ce8\u518c\u5e76\u975e\u6613\u4e8b\u3002\u968f\u7740\u5370\u5c3c\u536b\u751f\u90e8 (KEMENKES) \u8981\u6c42\u7684\u4e0d\u65ad\u53d8\u5316\u548c\u65f6\u95f4\u8868\u7684\u8c03\u6574\uff0c\u56fd\u9645\u54c1\u724c\u82e5\u60f3\u72ec\u81ea\u5e94\u5bf9\u8fd9\u4e00\u590d\u6742\u7684\u5c40\u9762\uff0c\u5c06\u9762\u4e34\u5de8\u5927\u7684\u98ce\u9669\u3002\u5728\u77ac\u606f\u4e07\u53d8\u7684\u8bca\u65ad\u5e02\u573a\u4e2d\uff0c\u89c4\u5212\u9636\u6bb5\u6bcf\u505c\u6ede\u4e00\u4e2a\u5b63\u5ea6\uff0c\u5c31\u610f\u5473\u7740\u7ade\u4e89\u5bf9\u624b\u6709\u673a\u4f1a\u62a2\u5360\u91cd\u8981\u7684\u5206\u9500\u7f51\u7edc\u548c\u533b\u9662\u540d\u5f55\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5f52\u6839\u7ed3\u5e95\uff0c\u533a\u5206\u90a3\u4e9b\u8fc5\u901f\u6210\u529f\u7684\u54c1\u724c\u548c\u90a3\u4e9b\u82e6\u82e6\u6323\u624e\u7684\u54c1\u724c\u7684\u5173\u952e\u4e0d\u5728\u4e8e\u4ea7\u54c1\u8d28\u91cf\uff0c\u800c\u5728\u4e8e\u51c6\u5907\u5de5\u4f5c\u548c\u5408\u4f5c\u4f19\u4f34\u5173\u7cfb\u3002\u4e0e\u4e13\u4e1a\u516c\u53f8\u5408\u4f5c\u53ef\u4ee5\u5f25\u5408\u8fd9\u4e00\u5dee\u8ddd\uff0c\u4ed6\u4eec\u4f1a\u8d1f\u8d23\u4ece\u6700\u521d\u7684\u4ea7\u54c1\u5206\u7c7b\u548cCSDT\u51c6\u5907\u5230NIE\u7b7e\u53d1\u7684\u6240\u6709\u73af\u8282\uff0c\u8ba9\u60a8\u53ef\u4ee5\u4e13\u6ce8\u4e8e\u5546\u4e1a\u589e\u957f\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4f5c\u4e3a\u60a8\u4e13\u5c5e\u7684\u76d1\u7ba1\u5408\u4f5c\u4f19\u4f34\uff0c, <strong>\u4ea7\u54c1\u6ce8\u518c\u5370\u5ea6\u5c3c\u897f\u4e9a<\/strong> \u6211\u4eec\u5df2\u505a\u597d\u5145\u5206\u51c6\u5907\uff0c\u52a9\u60a8\u7b80\u5316\u8fdb\u5165\u5370\u5c3c\u5e02\u573a\u7684\u6d41\u7a0b\u3002\u6211\u4eec\u62e5\u6709\u6df1\u539a\u7684\u672c\u5730\u4e13\u4e1a\u77e5\u8bc6\u3001\u6210\u719f\u7684\u4eba\u8109\u5173\u7cfb\u4ee5\u53ca\u5728\u4f53\u5916\u8bca\u65ad (IVD) \u5404\u4e2a\u9886\u57df\u7684\u5b9e\u8df5\u7ecf\u9a8c\uff0c\u80fd\u591f\u5e2e\u52a9\u56fd\u9645\u54c1\u724c\u9ad8\u6548\u3001\u51c6\u786e\u5730\u5b8c\u6210\u6ce8\u518c\u6d41\u7a0b\u3002\u4ece\u5b9e\u9a8c\u5ba4\u534f\u8c03\u5230\u7533\u62a5\u7ba1\u7406\uff0c\u6211\u4eec\u7684\u56e2\u961f\u786e\u4fdd\u60a8\u7684\u5408\u89c4\u7b56\u7565\u4e07\u65e0\u4e00\u5931\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5370\u5c3c\u5e02\u573a\u6b63\u655e\u5f00\u5927\u95e8\u3002\u7acb\u5373\u4e0e\u6211\u4eec\u5408\u4f5c\uff0c\u786e\u4fdd\u60a8\u7684\u6587\u4ef6\u51c6\u5907\u9f50\u5168\uff0c\u98ce\u9669\u964d\u81f3\u6700\u4f4e\uff0c\u52a9\u60a8\u987a\u5229\u8fdb\u5165\u5e02\u573a\u3002.<\/p>","protected":false},"excerpt":{"rendered":"<p>Indonesia&#8217;s diagnostics market is growing fast, and foreign brands that move now stand to capture serious ground. But breaking into this market is not simply a matter of having a world-class product.&nbsp; For any American or European manufacturer shipping diagnostic kits, reagents, or analyzers into the Indonesian market, IVD registration Indonesia is a non-negotiable regulatory [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":5923,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[45],"tags":[],"country":[],"class_list":["post-5922","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\/5922","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\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/comments?post=5922"}],"version-history":[{"count":2,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts\/5922\/revisions"}],"predecessor-version":[{"id":6529,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/posts\/5922\/revisions\/6529"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/media\/5923"}],"wp:attachment":[{"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/media?parent=5922"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/categories?post=5922"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/tags?post=5922"},{"taxonomy":"country","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/zh\/wp-json\/wp\/v2\/country?post=5922"}],"curies":[{"name":"\u53ef\u6e7f\u6027\u7c89\u5242","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}