{"id":3586,"date":"2025-11-17T08:32:00","date_gmt":"2025-11-17T01:32:00","guid":{"rendered":"https:\/\/productregistrationindonesia.com\/?p=3586"},"modified":"2025-12-10T22:12:11","modified_gmt":"2025-12-10T15:12:11","slug":"chinese-medical-device-registration-complete-guide-for-global-manufacturers","status":"publish","type":"post","link":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/chinese-medical-device-registration-complete-guide-for-global-manufacturers\/","title":{"rendered":"\u4e2d\u56fd\u533b\u7642\u6a5f\u5668\u767b\u9332\uff1a\u30b0\u30ed\u30fc\u30d0\u30eb\u30e1\u30fc\u30ab\u30fc\u5411\u3051\u5b8c\u5168\u30ac\u30a4\u30c9"},"content":{"rendered":"<p>\u4e2d\u56fd\u306e\u533b\u7642\u6a5f\u5668\u5e02\u5834\u306b\u53c2\u5165\u3059\u308b\u306b\u306f\u3001\u898f\u5236\u5f53\u5c40\u304c\u7ba1\u7406\u3059\u308b\u69cb\u9020\u5316\u3055\u308c\u305f\u898f\u5236\u67a0\u7d44\u307f\u306b\u6e96\u62e0\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002 <a href=\"https:\/\/www.easychinapprov.com\/NMPA\" target=\"_blank\" rel=\"noopener\">\u56fd\u5bb6\u533b\u85ac\u54c1\u5c40\uff08NMPA\uff09<\/a>. NMPA\u306f\u4e2d\u56fd\u306e\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b\u4e2d\u592e\u6a5f\u95a2\u3067\u3042\u308a\u3001\u5e02\u5834\u8a8d\u53ef\u3001\u5e02\u8ca9\u5f8c\u76e3\u8996\u3001\u56fd\u5bb6\u6280\u8853\u57fa\u6e96\u306e\u7dad\u6301\u306b\u8cac\u4efb\u3092\u8ca0\u3063\u3066\u3044\u307e\u3059\u3002\u305d\u306e\u6280\u8853\u8a55\u4fa1\u6a5f\u95a2\u3067\u3042\u308b\u533b\u7642\u6a5f\u5668\u8a55\u4fa1\u30bb\u30f3\u30bf\u30fc\uff08CMDE\uff09\u306f\u3001\u65b0\u898f\u767b\u9332\u3001\u66f4\u65b0\u767b\u9332\u3001\u5909\u66f4\u767b\u9332\u3092\u542b\u3080\u3059\u3079\u3066\u306e\u7533\u8acb\u306b\u3064\u3044\u3066\u79d1\u5b66\u7684\u5be9\u67fb\u3092\u884c\u3063\u3066\u3044\u307e\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u524d\u63d0\u6761\u4ef6\u3068\u5206\u985e<\/strong> \u4e2d\u56fd\u533b\u7642\u6a5f\u5668\u767b\u9332<\/h2>\n\n\n\n<p>\u4e2d\u56fd\u306b\u304a\u3051\u308b\u307b\u3068\u3093\u3069\u306e\u88fd\u54c1\u306e\u524d\u63d0\u6761\u4ef6\u306f\u3001\u6709\u52b9\u306a\u56fd\u5185\u5e02\u5834\u5411\u3051\u88fd\u54c1\u8a3c\u660e\u66f8\u3068\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\uff08\u591a\u304f\u306e\u5834\u5408 ISO 13485\uff09\u3092\u5099\u3048\u3066\u3044\u308b\u3053\u3068\u3067\u3059\u3002.<\/p>\n\n\n\n<p>\u533b\u7642\u6a5f\u5668\u767b\u9332\u3092\u7533\u8acb\u3059\u308b\u524d\u306b\u3001\u88fd\u9020\u696d\u8005\u306f NMPA \u898f\u5247\u306b\u5f93\u3063\u3066\u6a5f\u5668\u306e\u5206\u985e\u3068\u5bfe\u5fdc\u3059\u308b\u88fd\u54c1\u30b3\u30fc\u30c9\u3092\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<p>\u6a5f\u5668\u306f\u3001\u30ea\u30b9\u30af\u30ec\u30d9\u30eb\u3068\u4f7f\u7528\u76ee\u7684\u306b\u57fa\u3065\u304d\u3001\u30af\u30e9\u30b9I\u3001\u30af\u30e9\u30b9II\u3001\u30af\u30e9\u30b9III\u306b\u5206\u985e\u3055\u308c\u307e\u3059\u3002\u9069\u5207\u306a\u5206\u985e\u3092\u6c7a\u5b9a\u3059\u308b\u3053\u3068\u306f\u3001\u6280\u8853\u6587\u66f8\u306e\u8a73\u7d30\u306a\u5185\u5bb9\u3068\u81e8\u5e8a\u8981\u4ef6\u3092\u5b9a\u7fa9\u3059\u308b\u305f\u3081\u3001\u4e0d\u53ef\u6b20\u3067\u3059\u3002.<\/p>\n\n\n\n<p>\u305f\u3068\u3048\u3070\u3001\u30af\u30e9\u30b9 I \u30c7\u30d0\u30a4\u30b9\u306f\u8a18\u9332\u7533\u8acb\u30d7\u30ed\u30bb\u30b9\u3092\u901a\u3058\u3066\u7533\u8acb\u3067\u304d\u308b\u3053\u3068\u304c\u591a\u3044\u3067\u3059\u304c\u3001\u30af\u30e9\u30b9 II \u304a\u3088\u3073\u30af\u30e9\u30b9 III \u30c7\u30d0\u30a4\u30b9\u306b\u306f\u3001\u8a8d\u5b9a\u3055\u308c\u305f\u4e2d\u56fd\u306e\u7814\u7a76\u6240\u306b\u3088\u308b\u5b8c\u5168\u306a\u6280\u8853\u30ec\u30d3\u30e5\u30fc\u3068\u88fd\u54c1\u30c6\u30b9\u30c8\u304c\u5fc5\u8981\u3067\u3059\u3002.\u00a0<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u767b\u9332\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb: \u521d\u56de\u767b\u9332\u3001\u5909\u66f4\u3001\u66f4\u65b0<\/strong><\/h2>\n\n\n\n<p>NMPA\u306e\u767b\u9332\u30d7\u30ed\u30bb\u30b9\u306f\u3001\u5b8c\u5168\u306a\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306b\u5f93\u3063\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306b\u306f\u3001\u521d\u56de\u767b\u9332\u3001\u5909\u66f4\u767b\u9332\u3001\u305d\u3057\u30665\u5e74\u3054\u3068\u306e\u66f4\u65b0\uff08\u5ef6\u9577\u3068\u3082\u547c\u3070\u308c\u307e\u3059\uff09\u304c\u542b\u307e\u308c\u307e\u3059\u3002.<\/p>\n\n\n\n<p>\u521d\u56de\u767b\u9332\u306b\u306f\u3001NMPA\u96fb\u5b50\u30b7\u30b9\u30c6\u30e0\u306b\u3088\u308b\u66f8\u985e\u63d0\u51fa\u3001\u4e2d\u56fd\u306e\u8a8d\u5b9a\u8a66\u9a13\u6a5f\u95a2\u3067\u306e\u578b\u5f0f\u8a66\u9a13\u3001CMDE\u306b\u3088\u308b\u591a\u6bb5\u968e\u306e\u6280\u8853\u5be9\u67fb\u304c\u542b\u307e\u308c\u307e\u3059\u3002\u627f\u8a8d\u5f8c\u3001\u767b\u9332\u8a3c\u304c\u767a\u884c\u3055\u308c\u30015\u5e74\u9593\u6709\u52b9\u3068\u306a\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<p>\u88fd\u54c1\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u4e2d\u3001\u8a2d\u8a08\u3001\u66f8\u985e\u3001\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u3078\u306e\u5909\u66f4\u306f\u3001\u5909\u66f4\u767b\u9332\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3059\u304b\u3069\u3046\u304b\u3092\u5224\u65ad\u3059\u308b\u305f\u3081\u306b\u8a55\u4fa1\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002NMPA\u306e <a href=\"https:\/\/www.easychinapprov.com\/change-registration\" target=\"_blank\" rel=\"noopener\">\u767b\u9332\u8981\u4ef6\u306e\u5909\u66f4<\/a>, \u88fd\u54c1\u540d\u306e\u66f4\u65b0\u3084\u7ba1\u7406\u4e0a\u306e\u4fee\u6b63\u306a\u3069\u3001\u7279\u5b9a\u306e\u66f4\u65b0\u306f\u7ba1\u7406\u4e0a\u306e\u5909\u66f4\u3068\u3057\u3066\u63d0\u51fa\u3067\u304d\u307e\u3059\u3002\u305f\u3060\u3057\u3001\u91cd\u8981\u306a\u6280\u8853\u5909\u66f4\u3084\u8a2d\u8a08\u5909\u66f4\u306b\u3064\u3044\u3066\u306f\u3001\u6b63\u5f0f\u306a\u5909\u66f4\u5be9\u67fb\u3092\u53d7\u3051\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<p>\u300c\u91cd\u5927\u300d\u3068\u307f\u306a\u3055\u308c\u308b\u5909\u66f4\u306b\u306f\u3001\u610f\u56f3\u3055\u308c\u305f\u7528\u9014\u3001\u57fa\u672c\u7684\u306a\u8a2d\u8a08\u539f\u7406\u3001\u539f\u6750\u6599\u3001\u6ec5\u83cc\u65b9\u6cd5\u306e\u66f4\u65b0\u3001\u307e\u305f\u306f\u6a5f\u5668\u306e\u6027\u80fd\u3084\u5b89\u5168\u6027\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u5927\u5e45\u306a\u5909\u66f4\u304c\u542b\u307e\u308c\u307e\u3059\u3002\u3053\u306e\u3088\u3046\u306a\u5909\u66f4\u306b\u306f\u3001\u5fc5\u305aNMPA\u3078\u306e\u518d\u63d0\u51fa\u3068\u65b0\u3057\u3044\u578b\u5f0f\u8a66\u9a13\u7d50\u679c\u306e\u63d0\u51fa\u304c\u5fc5\u8981\u3067\u3059\u3002.<\/p>\n\n\n\n<p>\u8ca9\u58f2\u627f\u8a8d\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306b\u306f\u30015\u5e74\u3054\u3068\u306b\u66f4\u65b0\u304c\u5fc5\u9808\u3067\u3059\u3002\u66f4\u65b0\u7533\u8acb\u3067\u306f\u3001\u7d99\u7d9a\u7684\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3001\u6027\u80fd\u306e\u4e00\u8cab\u6027\u3001\u305d\u3057\u3066\u767b\u9332\u671f\u9593\u4e2d\u306b\u884c\u308f\u308c\u305f\u898f\u683c\u3084\u30e9\u30d9\u30eb\u306e\u66f4\u65b0\u3092\u8a3c\u660e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u30ec\u30d3\u30e5\u30fc\u306e\u6642\u9593\u3068\u30b3\u30b9\u30c8<\/strong> \u533b\u7642\u6a5f\u5668\u767b\u9332<\/h2>\n\n\n\n<p>\u5be9\u67fb\u6642\u9593\u3068\u6b63\u5f0f\u306a\u8cbb\u7528\u306f\u3001\u6a5f\u5668\u306e\u5206\u985e\u3068\u8a66\u9a13\u8981\u4ef6\u306b\u3088\u3063\u3066\u7570\u306a\u308a\u307e\u3059\u3002\u307b\u3068\u3093\u3069\u306e\u88fd\u54c1\u306e\u5834\u5408\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u30af\u30e9\u30b9II\u533b\u7642\u6a5f\u5668<\/strong> \u66f8\u985e\u306e\u6e96\u5099\u304b\u3089\u8a3c\u660e\u66f8\u306e\u767a\u884c\u307e\u3067\u7d0416\uff5e24\u304b\u6708\u304b\u304b\u308a\u307e\u3059\u3002.<\/li>\n\n\n\n<li><strong>\u30af\u30e9\u30b9III\u30c7\u30d0\u30a4\u30b9<\/strong>, \u3088\u308a\u8907\u96d1\u306a\u691c\u67fb\u3084\u5834\u5408\u306b\u3088\u3063\u3066\u306f\u81e8\u5e8a\u8a55\u4fa1\u3092\u53d7\u3051\u308b\u305f\u3081\u3001\u901a\u5e38\u306f 24 \uff5e 36 \u304b\u6708\u304b\u304b\u308a\u307e\u3059\u3002.<\/li>\n<\/ul>\n\n\n\n<p>\u516c\u5f0f\u5be9\u67fb\u6599\u91d1\u3001\u8a66\u9a13\u6599\u91d1\u3001\u7ffb\u8a33\u8cbb\u7528\u306f\u305d\u308c\u305e\u308c\u7570\u306a\u308a\u307e\u3059\u3002\u4e88\u60f3\u3055\u308c\u308b\u5be9\u67fb\u671f\u9593\u3001\u5be9\u67fb\u6bb5\u968e\u3001\u6a19\u6e96\u7684\u306a\u653f\u5e9c\u624b\u6570\u6599\u306e\u8a73\u7d30\u306a\u5185\u8a33\u306f\u3053\u3061\u3089\u3092\u3054\u89a7\u304f\u3060\u3055\u3044\u3002 <a href=\"https:\/\/www.easychinapprov.com\/time-and-cost\" target=\"_blank\" rel=\"noopener\">\u3053\u3053<\/a>.<\/p>\n\n\n\n<p>\u9069\u5207\u306b\u6e96\u5099\u3055\u308c\u305f\u6280\u8853\u6587\u66f8\u3068\u30c6\u30b9\u30c8\u6a5f\u95a2\u3068\u306e\u65e9\u671f\u306e\u9023\u643a\u306b\u3088\u308a\u3001\u30ec\u30d3\u30e5\u30fc\u6642\u9593\u3092\u5927\u5e45\u306b\u77ed\u7e2e\u3067\u304d\u307e\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u6280\u8853\u6587\u66f8\u3068\u578b\u5f0f\u8a66\u9a13<\/strong><\/h2>\n\n\n\n<p>\u6280\u8853\u66f8\u985e\uff08TD\uff09\u306f\u3001NMPA\u306e\u8981\u4ef6\u306b\u57fa\u3065\u304f\u63d0\u51fa\u66f8\u985e\u306e\u4e2d\u6838\u3068\u306a\u308b\u3082\u306e\u3067\u3059\u3002TD\u306f\u3001\u6a5f\u5668\u306e\u8aac\u660e\u3001\u4f7f\u7528\u76ee\u7684\u3001\u8a2d\u8a08\u691c\u8a3c\u3068\u59a5\u5f53\u6027\u78ba\u8a8d\u3001\u88fd\u9020\u60c5\u5831\u3001\u54c1\u8cea\u7ba1\u7406\u6587\u66f8\u3001\u30ea\u30b9\u30af\u7ba1\u7406\u3001\u81e8\u5e8a\u7684\u30a8\u30d3\u30c7\u30f3\u30b9\uff08\u307e\u305f\u306f\u514d\u9664\u306e\u6b63\u5f53\u6027\uff09\u3001\u30e9\u30d9\u30ea\u30f3\u30b0\u3001\u30a2\u30d5\u30bf\u30fc\u30b5\u30fc\u30d3\u30b9\u8a08\u753b\u3092\u542b\u3080\u6a19\u6e96\u5316\u3055\u308c\u305f\u69cb\u9020\u306b\u5f93\u3063\u3066\u3044\u307e\u3059\u3002.<\/p>\n\n\n\n<p>\u4e2d\u56fd\u306e\u767b\u9332\u306e\u30e6\u30cb\u30fc\u30af\u306a\u70b9\u306f\u3001 <a href=\"https:\/\/www.easychinapprov.com\/type-testing\" target=\"_blank\" rel=\"noopener\">\u578b\u30c6\u30b9\u30c8\u30d7\u30ed\u30bb\u30b9<\/a>. \u4ed6\u306e\u591a\u304f\u306e\u5e02\u5834\u3068\u306f\u7570\u306a\u308a\u3001\u4e2d\u56fd\u3067\u306f\u901a\u5e38\u3001\u3059\u3079\u3066\u306e\u30af\u30e9\u30b9II\u304a\u3088\u3073III\u6a5f\u5668\u306b\u3064\u3044\u3066\u3001\u4e2d\u56fd\u56fd\u5185\u306eNMPA\u8a8d\u5b9a\u8a66\u9a13\u6240\u3067\u306e\u8a66\u9a13\u304c\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u8a66\u9a13\u7d50\u679c\u306fTD\u306e\u4e00\u90e8\u3068\u306a\u308a\u3001\u627f\u8a8d\u3055\u308c\u305f\u88fd\u54c1\u6280\u8853\u8981\u4ef6\uff08PTR\uff09\uff08\u4e2d\u56fd\u56fa\u6709\u306e\u6027\u80fd\u6307\u6a19\u3068\u5b89\u5168\u7279\u6027\u306e\u8981\u7d04\uff09\u306b\u4e00\u81f4\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<p>TD\u306e\u69cb\u7bc9\u65b9\u6cd5\u3001PTR\u306e\u7d71\u5408\u65b9\u6cd5\u3001\u304a\u3088\u3073\u578b\u5f0f\u8a66\u9a13\u30b5\u30f3\u30d7\u30eb\u306e\u6e96\u5099\u65b9\u6cd5\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001\u4ee5\u4e0b\u3092\u53c2\u7167\u3057\u3066\u304f\u3060\u3055\u3044\u3002 <a href=\"https:\/\/www.easychinapprov.com\/chinese-TD\" target=\"_blank\" rel=\"noopener\">\u4e2d\u56fd\u8a9e\u306e\u6280\u8853\u6587\u66f8<\/a>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u7279\u5225\u30eb\u30fc\u30c8\uff1a\u30d5\u30a1\u30b9\u30c8\u30c8\u30e9\u30c3\u30af\u3068\u30d1\u30a4\u30ed\u30c3\u30c8\u30be\u30fc\u30f3<\/strong><\/h2>\n\n\n\n<p>\u4e2d\u56fd\u306f\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u3092\u4fc3\u9032\u3057\u3001\u5e02\u5834\u53c2\u5165\u3092\u52a0\u901f\u3055\u305b\u308b\u305f\u3081\u3001\u7279\u5b9a\u306e\u533b\u7642\u6a5f\u5668\u306b\u3064\u3044\u3066\u30d1\u30a4\u30ed\u30c3\u30c8\u30be\u30fc\u30f3\u3068\u30d5\u30a1\u30b9\u30c8\u30c8\u30e9\u30c3\u30af\u30d1\u30b9\u30a6\u30a7\u30a4\u3092\u8a2d\u3051\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u30eb\u30fc\u30c8\u306f\u3001\u9769\u65b0\u7684\u306a\u533b\u7642\u6a5f\u5668\u3001\u7dca\u6025\u306e\u81e8\u5e8a\u30cb\u30fc\u30ba\u3001\u3042\u308b\u3044\u306f\u898f\u5236\u30a4\u30f3\u30d5\u30e9\u304c\u6574\u5099\u3055\u308c\u305f\u7279\u5b9a\u306e\u5730\u57df\u306b\u8f38\u5165\u3055\u308c\u308b\u56fd\u969b\u88fd\u54c1\u3092\u5bfe\u8c61\u3068\u3057\u3066\u3044\u307e\u3059\u3002.<\/p>\n\n\n\n<p>\u57fa\u6e96\u3092\u6e80\u305f\u3059\u88fd\u9020\u696d\u8005\u306f\u3001\u512a\u5148\u8a55\u4fa1\u307e\u305f\u306f\u4e26\u884c\u8a66\u9a13\u30fb\u5be9\u67fb\u306e\u305f\u3081\u306e\u7279\u5225\u306a\u30d5\u30a1\u30b9\u30c8\u30c8\u30e9\u30c3\u30af\u30eb\u30fc\u30c8\u3092\u901a\u3058\u3066\u7533\u8acb\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u3001\u627f\u8a8d\u307e\u3067\u306e\u671f\u9593\u3092\u5927\u5e45\u306b\u77ed\u7e2e\u3067\u304d\u307e\u3059\u3002\u8a73\u7d30\u3068\u9069\u683c\u57fa\u6e96\u306b\u3064\u3044\u3066\u306f\u3001 <a href=\"https:\/\/www.easychinapprov.com\/fast-track-in-chinese-pilot-zone\" target=\"_blank\" rel=\"noopener\">\u4e2d\u56fd\u306e\u30d1\u30a4\u30ed\u30c3\u30c8\u30be\u30fc\u30f3\u30ac\u30a4\u30c9\u306e\u30d5\u30a1\u30b9\u30c8\u30c8\u30e9\u30c3\u30af<\/a>.<\/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=\"FhJW1hsaR7\"><a href=\"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/halal-certification-for-chinese-medical-device-companies-entering-indonesia-to-gain-trust-and-compliance\/\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u9032\u51fa\u3059\u308b\u4e2d\u56fd\u533b\u7642\u6a5f\u5668\u4f01\u696d\u3078\u306e\u30cf\u30e9\u30fc\u30eb\u8a8d\u8a3c\u53d6\u5f97\u3001\u4fe1\u983c\u3068\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u78ba\u4fdd\u3078<\/a><\/blockquote><iframe class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; visibility: hidden;\" title=\"\u201c\u300c\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u9032\u51fa\u3059\u308b\u4e2d\u56fd\u533b\u7642\u6a5f\u5668\u4f01\u696d\u306e\u305f\u3081\u306e\u30cf\u30e9\u30fc\u30eb\u8a8d\u8a3c\uff1a\u4fe1\u983c\u3068\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u7372\u5f97\u300d\u2014\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u88fd\u54c1\u767b\u9332\" src=\"https:\/\/stage-main-2025.productregistrationindonesia.com\/halal-certification-for-chinese-medical-device-companies-entering-indonesia-to-gain-trust-and-compliance\/embed\/#?secret=gBYmVTaHAL#?secret=FhJW1hsaR7\" data-secret=\"FhJW1hsaR7\" width=\"600\" height=\"338\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe>\n<\/div><\/figure>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>\u4e16\u754c\u7684\u306a\u898f\u5236\u7bc4\u56f2\u3092\u62e1\u5927\u3059\u308b\u305f\u3081\u306e\u30d1\u30fc\u30c8\u30ca\u30fc\u30b7\u30c3\u30d7<\/strong><\/h4>\n\n\n\n<p><a href=\"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u88fd\u54c1\u767b\u9332<\/a> \u3068\u5354\u529b\u4e2d <a href=\"https:\/\/www.easychinapprov.com\/\" target=\"_blank\" rel=\"noopener\">\u30a4\u30fc\u30b8\u30fc\u30c1\u30f3\u627f\u8a8dV<\/a>, \u533b\u7642\u6a5f\u5668\u767b\u9332\u306b\u95a2\u3059\u308b\u4e16\u754c\u7684\u306a\u898f\u5236\u30cd\u30c3\u30c8\u30ef\u30fc\u30af\u3092\u5f37\u5316\u3059\u308b\u305f\u3081\u3001\u30c9\u30a4\u30c4\u306b\u62e0\u70b9\u3092\u7f6e\u304f \u3092\u8a2d\u7acb\u3057\u307e\u3057\u305f\u3002.<\/p>\n\n\n\n<p>\u3053\u306e\u30d1\u30fc\u30c8\u30ca\u30fc\u30b7\u30c3\u30d7\u3092\u901a\u3058\u3066\u3001Product Registration Indonesia \u306f\u3001BPOM\u3001MoH\u3001\u30cf\u30e9\u30fc\u30eb\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u542b\u3080\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u8907\u96d1\u306a\u627f\u8a8d\u30d7\u30ed\u30bb\u30b9\u306b\u5bfe\u5fdc\u3059\u308b\u305f\u3081\u306e\u5b9f\u7e3e\u306e\u3042\u308b\u5c02\u9580\u77e5\u8b58\u3092\u63d0\u4f9b\u3057\u3001EasyChinApproV \u306f\u4e2d\u56fd\u306e NMPA \u767b\u9332\u30b7\u30b9\u30c6\u30e0\u306b\u95a2\u3059\u308b\u8a73\u7d30\u306a\u77e5\u8b58\u3068\u5b9f\u8df5\u7684\u306a\u7d4c\u9a13\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002.<\/p>\n\n\n\n<p>\u5f0a\u793e\u306f\u5354\u529b\u3057\u3066\u3001\u30e1\u30fc\u30ab\u30fc\u304c\u30a2\u30b8\u30a2\u3068\u30e8\u30fc\u30ed\u30c3\u30d1\u5168\u4f53\u3067\u30b7\u30fc\u30e0\u30ec\u30b9\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u6226\u7565\u3092\u69cb\u7bc9\u3057\u3001\u3088\u308a\u8fc5\u901f\u306a\u5e02\u5834\u30a2\u30af\u30bb\u30b9\u3001\u6587\u66f8\u306e\u76f8\u4e92\u627f\u8a8d\u3001\u305d\u3057\u3066\u771f\u306b\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u767b\u9332\u30ed\u30fc\u30c9\u30de\u30c3\u30d7\u3092\u78ba\u5b9f\u306b\u69cb\u7bc9\u3067\u304d\u308b\u3088\u3046\u652f\u63f4\u3057\u307e\u3059\u3002.<\/p>","protected":false},"excerpt":{"rendered":"<p>Entering the Chinese medical device market requires compliance with a structured regulatory framework managed by the National Medical Products Administration (NMPA). The NMPA is China\u2019s central authority for medical devices, responsible for market authorization, post-market supervision, and maintaining national technical standards. Its technical evaluation body, the Center for Medical Device Evaluation (CMDE), conducts scientific reviews of all submissions, including initial, renewal, and change registrations. Prerequisites &amp; Classification of Chinese Medical Device Registration The prerequisite for most products in China is to have a valid home market product certificate and quality management system, often ISO 13485. Before applying for medical device registration, manufacturers must confirm the device\u2019s classification and corresponding product [&hellip;]<\/p>\n","protected":false},"author":7,"featured_media":3590,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"country":[],"class_list":["post-3586","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"acf":[],"_links":{"self":[{"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/3586","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/comments?post=3586"}],"version-history":[{"count":2,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/3586\/revisions"}],"predecessor-version":[{"id":3591,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/3586\/revisions\/3591"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/media\/3590"}],"wp:attachment":[{"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/media?parent=3586"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/categories?post=3586"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/tags?post=3586"},{"taxonomy":"country","embeddable":true,"href":"https:\/\/stage-main-2025.productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/country?post=3586"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}