{"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\/ja\/ivd-registration-indonesia\/","title":{"rendered":"\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\uff08IVD\uff09\u767b\u9332\uff1a\u30a2\u30e1\u30ea\u30ab\u304a\u3088\u3073\u30e8\u30fc\u30ed\u30c3\u30d1\u30d6\u30e9\u30f3\u30c9\u306e\u305f\u3081\u306e\u7a76\u6975\u30ac\u30a4\u30c9"},"content":{"rendered":"<p 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class=\"wp-block-paragraph\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u5e02\u5834\u306b\u8a3a\u65ad\u30ad\u30c3\u30c8\u3001\u8a66\u85ac\u3001\u307e\u305f\u306f\u5206\u6790\u88c5\u7f6e\u3092\u51fa\u8377\u3059\u308b\u30a2\u30e1\u30ea\u30ab\u307e\u305f\u306f\u30e8\u30fc\u30ed\u30c3\u30d1\u306e\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\uff08IVD\uff09\u306e\u767b\u9332\u306f\u3001\u7dbf\u5bc6\u306a\u6e96\u5099\u3001\u9069\u5207\u306a\u66f8\u985e\u4f5c\u6210\u3001\u305d\u3057\u3066\u4fe1\u983c\u3067\u304d\u308b\u73fe\u5730\u30d1\u30fc\u30c8\u30ca\u30fc\u3092\u5fc5\u8981\u3068\u3059\u308b\u3001\u8b72\u308b\u3053\u3068\u306e\u3067\u304d\u306a\u3044\u898f\u5236\u4e0a\u306e\u91cd\u8981\u306a\u30b9\u30c6\u30c3\u30d7\u3067\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u653f\u5e9c\u304c\u8a3a\u65ad\u30a4\u30f3\u30d5\u30e9\u306e\u5f37\u5316\u3092\u63a8\u9032\u3057\u3066\u304d\u305f\u3053\u3068\u3001\u7279\u306b\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u4ee5\u964d\u306f\u3001\u78ba\u7acb\u3055\u308c\u305f\u56fd\u969b\u5e02\u5834\u304b\u3089\u9ad8\u54c1\u8cea\u306e\u4f53\u5916\u8a3a\u65ad\u7528\u88fd\u54c1\u306b\u3068\u3063\u3066\u771f\u306e\u5546\u696d\u7684\u6a5f\u4f1a\u304c\u751f\u307e\u308c\u305f\u3002.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3057\u304b\u3057\u3001\u591a\u304f\u306e\u6d77\u5916\u30e1\u30fc\u30ab\u30fc\u306f\u6e96\u5099\u4e0d\u8db3\u306e\u307e\u307e\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u9032\u51fa\u3057\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u898f\u5236\u74b0\u5883\u304cEU\u3084\u7c73\u56fd\u3068\u3069\u308c\u307b\u3069\u7570\u306a\u308b\u304b\u3092\u904e\u5c0f\u8a55\u4fa1\u3057\u3066\u3044\u308b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u306e\u30ac\u30a4\u30c9\u3067\u306f\u3001\u5916\u56fd\u30d6\u30e9\u30f3\u30c9\u304c\u77e5\u3063\u3066\u304a\u304f\u3079\u304d\u3059\u3079\u3066\u306e\u4e8b\u9805\u3001\u3059\u306a\u308f\u3061\u30ea\u30b9\u30af\u5206\u985e\u3001\u30e9\u30dc\u8a66\u9a13\u8981\u4ef6\u3001\u6280\u8853\u6587\u66f8\uff08CSDT\uff09\u3001\u304a\u3088\u3073\u95a2\u9023\u3059\u308b\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u898f\u5236\u306b\u3064\u3044\u3066\u89e3\u8aac\u3057\u3066\u3044\u307e\u3059\u3002.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u304c\u4f53\u5916\u8a3a\u65ad\u85ac\u30d6\u30e9\u30f3\u30c9\u306b\u3068\u3063\u3066\u512a\u5148\u5e02\u5834\u3067\u3042\u308b\u7406\u7531\u3068\u306f\uff1f<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6771\u5357\u30a2\u30b8\u30a2\u6700\u5927\u306e\u7d4c\u6e08\u56fd\u306f\u3001\u533b\u7642\u5236\u5ea6\u3078\u306e\u6295\u8cc7\u3092\u7d99\u7d9a\u3057\u3066\u3044\u308b\u3002\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u653f\u5e9c\u306eJKN\uff08<a href=\"https:\/\/bpjs-kesehatan.go.id\/#\/\" target=\"_blank\" rel=\"noopener\">\u30b8\u30e3\u30df\u30ca\u30f3\u30fb\u30b1\u30bb\u30cf\u30bf\u30f3\u30fb\u30ca\u30b7\u30e7\u30ca\u30eb<\/a>\uff09\u56fd\u6c11\u7686\u4fdd\u967a\u5236\u5ea6\u306e\u666e\u53ca\u306b\u4f34\u3044\u3001\u75c5\u9662\u3068\u8a3a\u7642\u6240\u306e\u4e21\u65b9\u3067\u3001\u624b\u9803\u306a\u4fa1\u683c\u3067\u4fe1\u983c\u6027\u306e\u9ad8\u3044\u8a3a\u65ad\u30c4\u30fc\u30eb\u306e\u9700\u8981\u304c\u6025\u5897\u3057\u3066\u3044\u308b\u3002.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u308c\u306f\u3001\u5358\u7d14\u306a\u8840\u7cd6\u5024\u6e2c\u5b9a\u5668\u304b\u3089\u8907\u96d1\u306a\u5206\u5b50\u8a3a\u65ad\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u307e\u3067\u3001\u3042\u3089\u3086\u308b\u3082\u306e\u306e\u5927\u898f\u6a21\u306a\u8abf\u9054\u3092\u4fc3\u9032\u3057\u3066\u3044\u308b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u30a2\u30e1\u30ea\u30ab\u3068\u30e8\u30fc\u30ed\u30c3\u30d1\u306eIVD\u4f01\u696d\u306b\u3068\u3063\u3066\u3001\u3053\u306e\u9700\u8981\u30b7\u30b0\u30ca\u30eb\u306f\u9b45\u529b\u7684\u3060\u3002\u3057\u304b\u3057\u3001\u5e02\u5834\u306b\u30a2\u30af\u30bb\u30b9\u3059\u308b\u306b\u306f\u30012\u3064\u306e\u4e3b\u8981\u306a\u7701\u5e81\u306e\u6a29\u9650\u3092\u3046\u307e\u304f\u5229\u7528\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002\u4fdd\u5065\u7701\uff08Kementerian Kesehatan\u3001\u307e\u305f\u306f <a href=\"https:\/\/kemkes.go.id\/id\/home\" target=\"_blank\" rel=\"noopener\">\u30b1\u30e1\u30f3\u30b1\u30b9<\/a>\u533b\u7642\u6a5f\u5668\u767b\u9332\u30b7\u30b9\u30c6\u30e0\u3092\u76e3\u7763\u3059\u308b\u6a5f\u95a2\u3001\u304a\u3088\u3073\u533b\u85ac\u54c1\u98df\u54c1\u7ba1\u7406\u5e81\uff08Badan Pengawas Obat dan Makanan\u3001\u4e00\u822c\u306b\u77e5\u3089\u308c\u3066\u3044\u308b\uff09 <a href=\"https:\/\/www.pom.go.id\/\" target=\"_blank\" rel=\"noopener\">BPOM<\/a>\uff09\u3001\u7279\u306b\u8a66\u85ac\u5316\u5b66\u3084\u751f\u7269\u5b66\u7684\u7269\u8cea\u306b\u95a2\u308f\u308b\u5206\u91ce\u306b\u304a\u3044\u3066\u3001\u652f\u63f4\u7684\u306a\u76e3\u7763\u306e\u5f79\u5272\u3092\u679c\u305f\u3057\u3066\u3044\u308b\u3002.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>\u91cd\u8981\u306a\u898f\u5236\u306b\u95a2\u3059\u308b\u6ce8\u610f\u4e8b\u9805<\/strong>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u3067\u306f\u3001\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\uff08IVD\uff09\u3092\u542b\u3080\u3059\u3079\u3066\u306e\u533b\u7642\u6a5f\u5668\u306f\u3001KEMENKES\uff08\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u4fdd\u5065\u7701\uff09\u304c\u767a\u884c\u3059\u308b\u516c\u5f0f\u88fd\u54c1\u767b\u9332\u756a\u53f7\u3067\u3042\u308bNomor Izin Edar\uff08NIE\uff09\u3092\u53d6\u5f97\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u6cd5\u5f8b\u3067\u306f\u3001NIE\u304c\u306a\u3044\u5834\u5408\u3001IVD\u88fd\u54c1\u306e\u8f38\u5165\u307e\u305f\u306f\u8ca9\u58f2\u306f\u8a31\u53ef\u3055\u308c\u3066\u3044\u307e\u305b\u3093\u3002.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u7642\u6a5f\u5668\uff08IVD\uff09\u306e\u30ea\u30b9\u30af\u5206\u985e\uff1a\u30af\u30e9\u30b9A\uff5eD<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306f\u3001\u533b\u7642\u6a5f\u5668\u3068 IVD \u306e\u5206\u985e\u30b7\u30b9\u30c6\u30e0\u3092 ASEAN \u533b\u7642\u6a5f\u5668\u6307\u4ee4 (AMDD) \u304a\u3088\u3073 ASEAN \u8abf\u548c\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u5e45\u5e83\u304f\u5408\u308f\u305b\u3066\u3044\u307e\u3059\u3002 Peraturan Menteri Kesehatan Nomor 62 Tahun 2017 tentang Izin Edar Alat Kesehatan\u3001In-vitro Diagnostic\u3001dan Perbekalan Kesehatan Rumah Tangga \u306e\u4e0b\u3067\u306f\u3001IVD \u306f 4 \u3064\u306e\u30ea\u30b9\u30af \u30af\u30e9\u30b9\u306b\u5206\u985e\u3055\u308c\u3066\u304a\u308a\u3001\u305d\u308c\u305e\u308c\u306b\u7570\u306a\u308b\u898f\u5236\u8981\u4ef6\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u30af\u30e9\u30b9A\uff1a\u4f4e\u30ea\u30b9\u30af<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u30af\u30e9\u30b9A\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\uff08IVD\uff09\u306f\u3001\u500b\u4eba\u307e\u305f\u306f\u516c\u8846\u306b\u5bfe\u3059\u308b\u30ea\u30b9\u30af\u304c\u6700\u5c0f\u9650\u3067\u3059\u3002\u8840\u7cd6\u5024\u6e2c\u5b9a\u30b9\u30c8\u30ea\u30c3\u30d7\u3084\u4e00\u822c\u7684\u306a\u5c3f\u691c\u67fb\u30ad\u30c3\u30c8\u306a\u3069\u304c\u3053\u306e\u30ab\u30c6\u30b4\u30ea\u30fc\u306b\u5206\u985e\u3055\u308c\u307e\u3059\u3002\u30af\u30e9\u30b9A\u88fd\u54c1\u306e\u767b\u9332\u306f\u7c21\u7d20\u5316\u3055\u308c\u3066\u304a\u308a\u3001\u88fd\u9020\u696d\u8005\u306f\u81ea\u5df1\u7533\u544a\u5236\u5ea6\uff08Pernyataan Mandiri\uff09\u3092\u5229\u7528\u3067\u304d\u308b\u5834\u5408\u304c\u3042\u308a\u3001\u66f8\u985e\u4f5c\u6210\u306e\u624b\u9593\u3068\u6240\u8981\u6642\u9593\u3092\u5927\u5e45\u306b\u524a\u6e1b\u3067\u304d\u307e\u3059\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u30af\u30e9\u30b9B\uff1a\u4f4e\uff5e\u4e2d\u30ea\u30b9\u30af<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u8840\u6db2\u5206\u6790\u88c5\u7f6e\u3084\u6a19\u6e96\u7684\u306a\u751f\u5316\u5b66\u691c\u67fb\u30ad\u30c3\u30c8\u306a\u3069\u306e\u88fd\u54c1\u306f\u3001\u4e00\u822c\u7684\u306b\u30af\u30e9\u30b9B\u306b\u5206\u985e\u3055\u308c\u307e\u3059\u3002\u7c21\u7565\u5316\u3055\u308c\u305f\u7533\u8acb\u66f8\u985e\u304c\u5fc5\u8981\u3068\u306a\u308a\u3001KEMENKES\uff08\u30b1\u30e1\u30f3\u30b1\u30b9\u533b\u85ac\u54c1\u30fb\u533b\u7642\u6a5f\u5668\u898f\u5236\u5e81\uff09\u304c\u6b63\u5f0f\u306a\u5be9\u67fb\u3092\u884c\u3044\u307e\u3059\u3002\u88fd\u54c1\u306e\u7a2e\u985e\u3084\u7528\u9014\u306b\u3088\u3063\u3066\u306f\u3001\u81e8\u5e8a\u691c\u67fb\u304c\u5fc5\u8981\u3068\u306a\u308b\u5834\u5408\u3068\u305d\u3046\u3067\u306a\u3044\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u30af\u30e9\u30b9C\uff1a\u4e2d\uff5e\u9ad8\u30ea\u30b9\u30af<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u8840\u6db2\u30d0\u30f3\u30af\u306e\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u8a66\u85ac\u3001\u5206\u5b50\u8a3a\u65ad\u30d1\u30cd\u30eb\u3001\u6162\u6027\u75be\u60a3\u30de\u30fc\u30ab\u30fc\u3092\u691c\u51fa\u3059\u308b\u691c\u67fb\u306f\u3001\u591a\u304f\u306e\u5834\u5408\u30af\u30e9\u30b9C\u306b\u5206\u985e\u3055\u308c\u307e\u3059\u3002\u3053\u306e\u30af\u30e9\u30b9\u3067\u306f\u3001\u5206\u6790\u691c\u8a3c\u30c7\u30fc\u30bf\u3092\u542b\u3080\u6027\u80fd\u8a3c\u62e0\u3092\u6dfb\u3048\u305f\u5b8c\u5168\u306aCSDT\uff08\u5171\u901a\u63d0\u51fa\u66f8\u985e\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\uff09\u306e\u63d0\u51fa\u304c\u5fc5\u8981\u3067\u3059\u3002\u8a8d\u5b9a\u65bd\u8a2d\u3067\u306e\u691c\u67fb\u306f\u5fc5\u9808\u3067\u3059\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\u30af\u30e9\u30b9D\uff1a\u9ad8\u30ea\u30b9\u30af<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u30af\u30e9\u30b9D\u306f\u3001HIV\u3001B\u578b\u809d\u708e\u3001C\u578b\u809d\u708e\u306a\u3069\u306e\u751f\u547d\u3092\u8105\u304b\u3059\u611f\u67d3\u75c7\u306e\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u306b\u4f7f\u7528\u3055\u308c\u308b\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\uff08IVD\uff09\u3084\u3001\u8840\u6db2\u578b\u5224\u5b9a\u30b7\u30b9\u30c6\u30e0\u3092\u5bfe\u8c61\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u88fd\u54c1\u306f\u3001\u5b8c\u5168\u306aCSDT\uff08\u81e8\u5e8a\u30c7\u30fc\u30bf\u30b7\u30fc\u30c8\uff09\u306e\u63d0\u51fa\u3001\u4fe1\u983c\u6027\u306e\u9ad8\u3044\u81e8\u5e8a\u6027\u80fd\u30c7\u30fc\u30bf\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u56fd\u5bb6\u898f\u683c\uff08SNI\uff09\u307e\u305f\u306f\u540c\u7b49\u306eISO\u898f\u683c\u306b\u6e96\u62e0\u3057\u305f\u5fc5\u9808\u8a66\u9a13\u306a\u3069\u3001\u6700\u3082\u9ad8\u3044\u30ec\u30d9\u30eb\u306e\u8a3c\u62e0\u63d0\u51fa\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u3053\u306e\u627f\u8a8d\u30d7\u30ed\u30bb\u30b9\u306f\u901a\u5e38\u3001\u7533\u8acb\u304b\u3089\u627f\u8a8d\u307e\u306712\uff5e18\u30f6\u6708\u304b\u304b\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>IVD\u30ea\u30b9\u30af\u5206\u985e\u6bd4\u8f03\u306e\u6982\u8981<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4ee5\u4e0b\u306e\u8868\u306f\u3001IVD\uff08\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\uff09\u306e4\u3064\u306e\u30ea\u30b9\u30af\u30af\u30e9\u30b9\u3001\u305d\u308c\u305e\u308c\u306e\u4ee3\u8868\u7684\u306a\u88fd\u54c1\u30ab\u30c6\u30b4\u30ea\u30fc\u3001\u898f\u5236\u7d4c\u8def\u3001\u76ee\u5b89\u3068\u306a\u308b\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u3001\u304a\u3088\u3073\u691c\u67fb\u6a5f\u95a2\u3067\u306e\u691c\u67fb\u7fa9\u52d9\u3092\u307e\u3068\u3081\u305f\u3082\u306e\u3067\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u308c\u306f\u3001\u81ea\u793e\u88fd\u54c1\u304c\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\u306b\u95a2\u3059\u308b\u5b8c\u5168\u306aBPOM\u6587\u66f8\u3092\u5fc5\u8981\u3068\u3059\u308b\u306e\u304b\u3001\u305d\u308c\u3068\u3082\u3088\u308a\u7c21\u7565\u5316\u3055\u308c\u305f\u30a2\u30d7\u30ed\u30fc\u30c1\u3067\u6e08\u3080\u306e\u304b\u3092\u8a55\u4fa1\u3057\u3066\u3044\u308b\u30d6\u30e9\u30f3\u30c9\u306b\u3068\u3063\u3066\u7279\u306b\u91cd\u8981\u3067\u3059\u3002.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>\u30af\u30e9\u30b9<\/strong><\/td><td><strong>\u4f8b<\/strong><\/td><td><strong>\u767b\u9332\u624b\u9806<\/strong><\/td><td><strong>\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3<\/strong><\/td><td><strong>\u30e9\u30dc\u30c6\u30b9\u30c8<\/strong><\/td><\/tr><tr><td>A\uff08\u4f4e\u30ea\u30b9\u30af\uff09<\/td><td>\u500b\u4eba\u7528\u8840\u7cd6\u5024\u6e2c\u5b9a\u5668\u3001\u598a\u5a20\u691c\u67fb\u30ad\u30c3\u30c8<\/td><td>\u81ea\u5df1\u5ba3\u8a00 (\u30da\u30eb\u30cb\u30e3\u30bf\u30fc\u30f3 \u30de\u30f3\u30c7\u30a3\u30ea)<\/td><td>3\uff5e6\u30f6\u6708<\/td><td>\u5fc5\u9808\u3067\u306f\u3042\u308a\u307e\u305b\u3093<\/td><\/tr><tr><td>B\uff08\u4f4e\uff5e\u4e2d\u7a0b\u5ea6\uff09<\/td><td>\u8840\u6db2\u5206\u6790\u88c5\u7f6e\u3001\u4e00\u822c\u5316\u5b66\u691c\u67fb<\/td><td>\u7c21\u7d20\u5316\u3055\u308c\u305f\u66f8\u985e + BPOM \u30ec\u30d3\u30e5\u30fc<\/td><td>6\uff5e9\u30f6\u6708<\/td><td>\u5fc5\u8981\u306b\u5fdc\u3058\u3066<\/td><\/tr><tr><td>C\uff08\u4e2d\uff5e\u9ad8\uff09<\/td><td>\u8840\u6db2\u30d0\u30f3\u30af\u7528\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u8a66\u85ac\u3001\u5206\u5b50\u8a3a\u65ad<\/td><td>CSDT\u306b\u95a2\u3059\u308b\u5b8c\u5168\u306a\u66f8\u985e\u4e00\u5f0f\u3068\u691c\u67fb\u7d50\u679c<\/td><td>9\uff5e15\u30f6\u6708<\/td><td>\u5fc5\u9808<\/td><\/tr><tr><td>D\uff08\u9ad8\u30ea\u30b9\u30af\uff09<\/td><td>HIV\u3001\u809d\u708e\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u30ad\u30c3\u30c8\u3001\u8840\u6db2\u578b\u5224\u5b9a<\/td><td>\u5b8c\u5168\u306aCSDT + \u81e8\u5e8a\/\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u30c7\u30fc\u30bf<\/td><td>12\uff5e18\u30f6\u6708<\/td><td>\u5fc5\u9808\uff08SNI\/ISO\uff09<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\u6ce8\uff1a\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u671f\u9593\u306f\u76ee\u5b89\u3067\u3042\u308a\u3001KEMENKES\u306e\u696d\u52d9\u91cf\u3001\u63d0\u51fa\u66f8\u985e\u306e\u5b8c\u5168\u6027\u3001\u304a\u3088\u3073\u8ffd\u52a0\u30c7\u30fc\u30bf\u306e\u8981\u6c42\u306b\u3088\u3063\u3066\u5909\u66f4\u3055\u308c\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002\u73fe\u5730\u306e\u5c02\u9580\u30d1\u30fc\u30c8\u30ca\u30fc\u3068\u9023\u643a\u3059\u308b\u3053\u3068\u3067\u3001\u3053\u308c\u3089\u306e\u671f\u9593\u3092\u5927\u5e45\u306b\u77ed\u7e2e\u3067\u304d\u308b\u5834\u5408\u304c\u591a\u304f\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\u306e\u691c\u67fb\u8981\u4ef6<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u6700\u3082\u904e\u5c0f\u8a55\u4fa1\u3055\u308c\u3066\u3044\u308b\u30b9\u30c6\u30c3\u30d7\u306e 1 \u3064\u306f\u3001 <a href=\"https:\/\/productregistrationindonesia.com\/ja\/services\/medical-device-registration-indonesia\/\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\uff08IVD\uff09\u306e\u767b\u9332\u624b\u7d9a\u304d<\/a> \u81e8\u5e8a\u691c\u67fb\u3068\u306f\u3001\u81e8\u5e8a\u73fe\u5834\u3067\u884c\u308f\u308c\u308b\u691c\u67fb\u306e\u3053\u3068\u3067\u3059\u3002.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u7b2c\u4e09\u56fd\u306e\u81e8\u5e8a\u30c7\u30fc\u30bf\u3067\u5341\u5206\u306a\u5834\u5408\u3082\u3042\u308b\u4ed6\u306e\u5e02\u5834\u3068\u306f\u7570\u306a\u308a\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u898f\u5236\u5f53\u5c40\u306f\u3001\u73fe\u5730\u3067\u8a8d\u3081\u3089\u308c\u305f\u65bd\u8a2d\u3001\u307e\u305f\u306fISO 17025\u306e\u8a8d\u5b9a\u3092\u53d7\u3051\u305f\u65bd\u8a2d\u3067\u5b9f\u65bd\u3055\u308c\u305f\u6027\u80fd\u8a66\u9a13\u3092\u8981\u6c42\u3059\u308b\u3053\u3068\u304c\u591a\u3044\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u30af\u30e9\u30b9C\u304a\u3088\u3073\u30af\u30e9\u30b9D\u88fd\u54c1\u306e\u5834\u5408\u3001\u8a66\u9a13\u7bc4\u56f2\u306f\u901a\u5e38\u4ee5\u4e0b\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u30fb\u73fe\u5730\u6761\u4ef6\u4e0b\u306b\u304a\u3051\u308b\u5206\u6790\u611f\u5ea6\u3068\u7279\u7570\u6027<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u30fb\u5730\u57df\u306b\u95a2\u9023\u3059\u308b\u59a8\u5bb3\u7269\u8cea\u3068\u306e\u4ea4\u5dee\u53cd\u5fdc\u6027\u8a66\u9a13<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u30fb\u7cbe\u5ea6\u3068\u518d\u73fe\u6027\uff08\u540c\u4e00\u6e2c\u5b9a\u5185\u304a\u3088\u3073\u6e2c\u5b9a\u9593\uff09<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u30fb\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u6c17\u5019\u6761\u4ef6\uff08\u6c17\u6e29\u3001\u6e7f\u5ea6\uff09\u4e0b\u3067\u306e\u5b89\u5b9a\u6027\u8a66\u9a13<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u30fb\u78ba\u7acb\u3055\u308c\u305f\u30b4\u30fc\u30eb\u30c9\u30b9\u30bf\u30f3\u30c0\u30fc\u30c9\u6cd5\u3068\u306e\u6bd4\u8f03\u81e8\u5e8a\u6027\u80fd<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u88fd\u9020\u696d\u8005\u306f\u3001\u88fd\u9020\u5de5\u7a0b\u306e\u65e9\u3044\u6bb5\u968e\u3067\u691c\u67fb\u5ba4\u3067\u306e\u8a66\u9a13\u3092\u8a08\u753b\u3059\u3079\u304d\u3067\u3042\u308b\u3002\u81ea\u793e\u306e\u7279\u5b9a\u306e\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\uff08IVD\uff09\u30ab\u30c6\u30b4\u30ea\u30fc\u306b\u5bfe\u5fdc\u3067\u304d\u308b\u8a8d\u5b9a\u691c\u67fb\u6a5f\u95a2\u3092\u898b\u3064\u3051\u308b\u3053\u3068\u306f\u5fc5\u305a\u3057\u3082\u5bb9\u6613\u3067\u306f\u306a\u304f\u3001\u30ab\u30c6\u30b4\u30ea\u30fc\u306b\u3088\u3063\u3066\u306f\u5927\u5b66\u75c5\u9662\u3084\u56fd\u7acb\u57fa\u6e96\u691c\u67fb\u6a5f\u95a2\u3068\u306e\u9023\u643a\u304c\u5fc5\u8981\u3068\u306a\u308b\u5834\u5408\u3082\u3042\u308b\u3002.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>\u6d77\u5916\u30d6\u30e9\u30f3\u30c9\u5411\u3051\u306e\u5b9f\u8df5\u7684\u306a\u30d2\u30f3\u30c8<\/strong>\u7814\u7a76\u6240\u306e\u8a8d\u5b9a\u53d6\u5f97\u3068\u8a66\u9a13\u8a08\u753b\u306f\u3001\u7533\u8acb\u4e88\u5b9a\u65e5\u306e\u5c11\u306a\u304f\u3068\u30826\u30f6\u6708\u524d\u304b\u3089\u958b\u59cb\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u8a66\u9a13\u306e\u4e0d\u5408\u683c\u3084\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u4e0d\u4e00\u81f4\u306f\u3001\u767b\u9332\u9045\u5ef6\u306e\u4e3b\u306a\u539f\u56e0\u306e\u4e00\u3064\u3067\u3059\u3002\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u7814\u7a76\u6240\u306e\u8981\u4ef6\u306b\u7cbe\u901a\u3057\u305f\u73fe\u5730\u306e\u898f\u5236\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u306f\u3001\u3053\u306e\u3088\u3046\u306a\u5834\u5408\u306b\u975e\u5e38\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u6280\u8853\u6587\u66f8\u306e\u7406\u89e3\uff1aCSDT<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u5171\u901a\u63d0\u51fa\u66f8\u985e\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\uff08CSDT\uff09\u306f\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u30af\u30e9\u30b9C\u304a\u3088\u3073\u30af\u30e9\u30b9D\u306e\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u7642\u6a5f\u5668\uff08IVD\uff09\u306e\u63d0\u51fa\u306b\u5fc5\u8981\u306a\u3001ASEAN\u3067\u7d71\u4e00\u3055\u308c\u305f\u6280\u8853\u30d5\u30a1\u30a4\u30eb\u5f62\u5f0f\u3067\u3059\u3002.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">EU IVDR\u306e\u6280\u8853\u6587\u66f8\u3084FDA 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class=\"wp-block-paragraph\">IVD\uff08\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\uff09\u306e\u767b\u9332\u7533\u8acb\u3092\u958b\u59cb\u3059\u308b\u524d\u306b\u3001\u898f\u5236\u67a0\u7d44\u307f\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u304c\u4e0d\u53ef\u6b20\u3067\u3059\u3002\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308bIVD\u88fd\u54c1\u306e\u767b\u9332\u3001\u8f38\u5165\u3001\u304a\u3088\u3073\u6d41\u901a\u306f\u3001\u4ee5\u4e0b\u306e\u898f\u5236\u306b\u3088\u3063\u3066\u898f\u5b9a\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u30fb\u4fdd\u5065\u5927\u81e3\u898f\u5247\u7b2c62\u53f7\uff082017\u5e74\uff09\uff1a\u533b\u7642\u6a5f\u5668\u3001\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\u3001\u5bb6\u5ead\u7528\u885b\u751f\u7528\u54c1\u306e\u8ca9\u58f2\u627f\u8a8d\uff08Izin 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class=\"wp-block-paragraph\">\u30fbSNI\uff08\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u56fd\u5bb6\u898f\u683c\uff09\uff1a\u7279\u5b9a\u306e\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\uff08IVD\uff09\u30ab\u30c6\u30b4\u30ea\u30fc\u3001\u7279\u306b\u30af\u30e9\u30b9D\u88fd\u54c1\u306b\u9069\u7528\u3055\u308c\u308b\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u56fd\u5bb6\u898f\u683c\u3002\u691c\u67fb\u6a5f\u95a2\u3067\u306e\u8a66\u9a13\u304a\u3088\u3073\u88fd\u54c1\u8a8d\u8a3c\u306e\u4e00\u74b0\u3068\u3057\u3066\u3001\u3053\u306e\u898f\u683c\u3078\u306e\u6e96\u62e0\u304c\u6c42\u3081\u3089\u308c\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u6700\u5f8c\u306b\uff1a\u79c1\u305f\u3061\u3068\u5171\u306b\u6210\u529f\u3078\u306e\u9053\u3092\u5207\u308a\u62d3\u304d\u307e\u3057\u3087\u3046<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\uff08IVD\uff09\u306e\u767b\u9332\u6210\u529f\u3078\u306e\u9053\u306f\u3001\u6c7a\u3057\u3066\u4e00\u76f4\u7dda\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u4fdd\u5065\u7701\uff08KEMENKES\uff09\u306e\u8981\u4ef6\u306f\u5e38\u306b\u5909\u5316\u3057\u3001\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u3082\u5909\u52d5\u3059\u308b\u305f\u3081\u3001\u3053\u306e\u8907\u96d1\u306a\u72b6\u6cc1\u3092\u72ec\u81ea\u306b\u4e57\u308a\u5207\u308b\u3053\u3068\u306f\u3001\u56fd\u969b\u7684\u306a\u30d6\u30e9\u30f3\u30c9\u306b\u3068\u3063\u3066\u5927\u304d\u306a\u30ea\u30b9\u30af\u3092\u4f34\u3044\u307e\u3059\u3002\u5909\u5316\u306e\u6fc0\u3057\u3044\u8a3a\u65ad\u5e02\u5834\u306b\u304a\u3044\u3066\u3001\u8a08\u753b\u6bb5\u968e\u3067\u505c\u6ede\u3059\u308b\u56db\u534a\u671f\u306f\u3001\u7af6\u5408\u4ed6\u793e\u304c\u91cd\u8981\u306a\u8ca9\u58f2\u4ee3\u7406\u5e97\u30cd\u30c3\u30c8\u30ef\u30fc\u30af\u3084\u75c5\u9662\u3078\u306e\u63b2\u8f09\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306e\u7d76\u597d\u306e\u6a5f\u4f1a\u3068\u306a\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<p 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<strong>\u88fd\u54c1\u767b\u9332\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2<\/strong> 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class=\"wp-block-paragraph\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u5e02\u5834\u3078\u306e\u53c2\u5165\u6a5f\u4f1a\u306f\u5927\u304d\u304f\u958b\u304b\u308c\u3066\u3044\u307e\u3059\u3002\u4eca\u3059\u3050\u5f53\u793e\u3068\u63d0\u643a\u3057\u3066\u3001\u5fc5\u8981\u306a\u66f8\u985e\u3092\u6e96\u5099\u3057\u3001\u30ea\u30b9\u30af\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u3001\u30b9\u30e0\u30fc\u30ba\u306a\u5e02\u5834\u53c2\u5165\u3092\u5b9f\u73fe\u3057\u307e\u3057\u3087\u3046\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 milestone that demands careful preparation, the right documentation, and a trusted local partner. The government&#8217;s push to strengthen diagnostic infrastructure, particularly after the pandemic years, has created real commercial opportunities for high-quality in-vitro diagnostic products from established international markets.&nbsp; Yet many foreign manufacturers arrive underprepared, underestimating how different the Indonesian regulatory landscape is from the [&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\/ja\/wp-json\/wp\/v2\/posts\/5922","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/comments?post=5922"}],"version-history":[{"count":2,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/5922\/revisions"}],"predecessor-version":[{"id":6529,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/5922\/revisions\/6529"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/media\/5923"}],"wp:attachment":[{"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/media?parent=5922"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/categories?post=5922"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/tags?post=5922"},{"taxonomy":"country","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/country?post=5922"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}