{"id":3143,"date":"2025-05-26T05:53:16","date_gmt":"2025-05-26T05:53:16","guid":{"rendered":"https:\/\/hanheng.easiwin.com\/?p=3143"},"modified":"2025-04-08T06:20:44","modified_gmt":"2025-04-08T06:20:44","slug":"medical-swab20250520","status":"publish","type":"post","link":"https:\/\/hanheng-medical.com\/ja\/blog\/medical-swab20250520\/","title":{"rendered":"\u533b\u7642\u7528\u7dbf\u68d2\u30e1\u30fc\u30ab\u30fc\u306f\u3069\u306e\u3088\u3046\u306a\u8a8d\u8a3c\u3092\u53d6\u5f97\u3059\u3079\u304d\u304b\uff1f"},"content":{"rendered":"<h2 class=\"wp-block-heading\" id=\"1-introduction-the-importance-of-certifications-in-medical-swab-manufacturing\">1.\u306f\u3058\u3081\u306b\u533b\u7642\u7528\u7dbf\u68d2\u88fd\u9020\u306b\u304a\u3051\u308b\u8a8d\u8a3c\u306e\u91cd\u8981\u6027<\/h2>\n\n\n\n<p>\u9ad8\u5ea6\u306b\u898f\u5236\u3055\u308c\u305f\u533b\u7642\u696d\u754c\u3067\u306f\u3001\u54c1\u8cea\u3001\u5b89\u5168\u6027\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306f\u8b72\u308c\u307e\u305b\u3093\u3002\u7279\u306b\u3001\u8a3a\u65ad\u691c\u67fb\u3001\u30b5\u30f3\u30d7\u30eb\u63a1\u53d6\u3001\u75c5\u6c17\u306e\u691c\u51fa\u306b\u4f7f\u7528\u3055\u308c\u308b\u533b\u7642\u7528\u7dbf\u68d2\u306b\u95a2\u3057\u3066\u306f\u306a\u304a\u3055\u3089\u3067\u3059\u3002\u75c5\u9662\u306e\u8abf\u9054\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u3001\u8a3a\u65ad\u30e9\u30dc\u306e\u30b9\u30da\u30b7\u30e3\u30ea\u30b9\u30c8\u3001\u533b\u7642\u7528\u7dbf\u68d2\u306e\u5378\u58f2\u3092\u304a\u8003\u3048\u306e\u30c7\u30a3\u30b9\u30c8\u30ea\u30d3\u30e5\u30fc\u30bf\u30fc\u306e\u3044\u305a\u308c\u306b\u3068\u3063\u3066\u3082\u3001\u8a8d\u5b9a\u533b\u7642\u7528\u7dbf\u68d2\u30e1\u30fc\u30ab\u30fc\u3092\u9078\u3076\u3053\u3068\u306f\u975e\u5e38\u306b\u91cd\u8981\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u533b\u7642\u7528\u7dbf\u68d2\u306f\u3001COVID-19\u3092\u542b\u3080\u611f\u67d3\u75c7\u3092\u691c\u51fa\u3059\u308b\u6700\u524d\u7dda\u306e\u30c4\u30fc\u30eb\u3067\u3042\u308b\u3001 <a href=\"https:\/\/en.wikipedia.org\/wiki\/Influenza\" target=\"_blank\" rel=\"noopener\">\u30a4\u30f3\u30d5\u30eb\u30a8\u30f3\u30b6<\/a>\u304a\u3088\u3073\u547c\u5438\u5668\u611f\u67d3\u75c7\u306e\u691c\u67fb\u306b\u4f7f\u7528\u3055\u308c\u308b\u3002\u3053\u308c\u3089\u306e\u30c4\u30fc\u30eb\u306f\u3001\u6b63\u78ba\u306a\u691c\u67fb\u7d50\u679c\u3068\u60a3\u8005\u306e\u5b89\u5168\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u3001\u53b3\u3057\u3044\u885b\u751f\u3001\u7121\u83cc\u3001\u6750\u6599\u5b89\u5168\u57fa\u6e96\u3092\u6e80\u305f\u3055\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u8a8d\u8a3c\u306f\u3001\u3053\u308c\u3089\u306e\u57fa\u6e96\u306b\u5bfe\u3059\u308b\u30e1\u30fc\u30ab\u30fc\u306e\u30b3\u30df\u30c3\u30c8\u30e1\u30f3\u30c8\u3092\u691c\u8a3c\u3059\u308b\u3001\u4e16\u754c\u7684\u306b\u8a8d\u3081\u3089\u308c\u305f\u30d9\u30f3\u30c1\u30de\u30fc\u30af\u3067\u3059\u3002<\/p>\n\n\n\n<p>B2B\u306e\u30d0\u30a4\u30e4\u30fc\u3084\u8abf\u9054\u62c5\u5f53\u8005\u306b\u3068\u3063\u3066\u3001\u533b\u7642\u7528\u7dbf\u68d2\u306e\u5378\u58f2\u696d\u8005\u304b\u3089\u8abf\u9054\u3059\u308b\u969b\u306b\u3001\u3069\u306e\u3088\u3046\u306a\u8a8d\u8a3c\u306b\u6ce8\u76ee\u3059\u3079\u304d\u304b\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u3067\u3001\u30ea\u30b9\u30af\u3092\u5927\u5e45\u306b\u8efd\u6e1b\u3057\u3001\u88fd\u54c1\u306e\u4fe1\u983c\u6027\u3092\u78ba\u4fdd\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002\u3053\u306e\u8a18\u4e8b\u3067\u306f\u3001\u533b\u7642\u7528\u7dbf\u68d2\u30e1\u30fc\u30ab\u30fc\u304c\u4fdd\u6709\u3059\u3079\u304d\u5fc5\u9808\u306e\u8a8d\u8a3c\u3068\u3001\u4f01\u696d\u304c\u305d\u308c\u3092\u78ba\u8a8d\u3059\u308b\u65b9\u6cd5\u3092\u63a2\u308b\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"why-certifications-matter-in-b2b-procurement\">B2B\u8abf\u9054\u306b\u304a\u3044\u3066\u8a8d\u8a3c\u304c\u91cd\u8981\u306a\u7406\u7531<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u88fd\u54c1\u306e\u4e00\u8cab\u6027\u3092\u78ba\u4fdd\u3059\u308b\uff1a<\/strong> \u8a8d\u8a3c\u30e1\u30fc\u30ab\u30fc\u306f\u6a19\u6e96\u5316\u3055\u308c\u305f\u624b\u9806\u306b\u5f93\u3044\u3001\u3070\u3089\u3064\u304d\u3092\u6291\u3048\u3066\u3044\u308b\u3002<\/li>\n\n\n\n<li><strong>\u898f\u5236\u9075\u5b88\u3092\u4fdd\u8a3c\uff1a<\/strong> \u4f01\u696d\u304c\u5730\u57df\u304a\u3088\u3073\u56fd\u969b\u7684\u306a\u898f\u5236\u8981\u4ef6\u3092\u6e80\u305f\u3059\u306e\u3092\u652f\u63f4\u3059\u308b\u3002<\/li>\n\n\n\n<li><strong>\u30d0\u30a4\u30e4\u30fc\u306e\u4fe1\u983c\u3092\u9ad8\u3081\u308b\uff1a<\/strong> 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class=\"wp-block-heading\" id=\"2-understanding-the-regulatory-landscape-for-medical-consumables\">2.\u533b\u7642\u6d88\u8017\u54c1\u306e\u898f\u5236\u72b6\u6cc1\u306e\u7406\u89e3<\/h2>\n\n\n\n<p>\u533b\u7642\u7528\u7dbf\u68d2\u306f\u3001\u305d\u306e\u7528\u9014\u306b\u3088\u3063\u3066\u30af\u30e9\u30b9I\u307e\u305f\u306f\u30af\u30e9\u30b9II\u306e\u533b\u7642\u6a5f\u5668\u306b\u5206\u985e\u3055\u308c\u307e\u3059\u3002\u4eba\u9593\u306e\u7d44\u7e54\u3084\u4f53\u6db2\u306b\u76f4\u63a5\u89e6\u308c\u308b\u3082\u306e\u3067\u3042\u308b\u305f\u3081\u3001\u6c5a\u67d3\u3084\u4ea4\u5dee\u611f\u67d3\u3001\u4e0d\u6b63\u78ba\u306a\u30b5\u30f3\u30d7\u30eb\u7d50\u679c\u3092\u9632\u3050\u305f\u3081\u306b\u3001\u53b3\u683c\u306a\u57fa\u6e96\u3092\u9075\u5b88\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"key-regulatory-bodies-overseeing-medical-swab-manufacturing\">\u533b\u7642\u7528\u7dbf\u68d2\u88fd\u9020\u3092\u76e3\u7763\u3059\u308b\u4e3b\u306a\u898f\u5236\u6a5f\u95a2<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u898f\u5236\u6a5f\u95a2<\/th><th>\u5730\u57df<\/th><th>\u6a5f\u80fd<\/th><\/tr><\/thead><tbody><tr><td><strong>\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09<\/strong><\/td><td>\u7c73\u56fd<\/td><td>\u30b9\u30ef\u30d6\u3092\u542b\u3080\u533b\u7642\u6a5f\u5668\u306e\u627f\u8a8d\u3068\u898f\u5236<\/td><\/tr><tr><td><strong>\u6b27\u5dde\u533b\u85ac\u54c1\u5e81\uff08EMA\uff09<\/strong> \/ CE\u30de\u30fc\u30ad\u30f3\u30b0<\/td><td>\u6b27\u5dde\u9023\u5408<\/td><td>EU\u306e\u5065\u5eb7\u3001\u5b89\u5168\u3001\u74b0\u5883\u57fa\u6e96\u3078\u306e\u9069\u5408\u3092\u4fdd\u8a3c\u3059\u308b\u3002<\/td><\/tr><tr><td><strong>\u56fd\u5bb6\u533b\u85ac\u54c1\u5c40\uff08NMPA\uff09<\/strong><\/td><td>\u4e2d\u56fd<\/td><td>\u4e2d\u56fd\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u304a\u3088\u3073\u6d88\u8017\u54c1\u306e\u898f\u5236<\/td><\/tr><tr><td><strong>\u56fd\u969b\u6a19\u6e96\u5316\u6a5f\u69cb\uff08ISO\uff09<\/strong><\/td><td>\u30b0\u30ed\u30fc\u30d0\u30eb<\/td><td>\u533b\u7642\u6a5f\u5668\u88fd\u9020\u306e\u305f\u3081\u306e\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u898f\u683c\u3092\u63d0\u4f9b<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"classification-of-medical-swabs\">\u533b\u7642\u7528\u7dbf\u68d2\u306e\u5206\u985e<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u7dbf\u68d2\u30bf\u30a4\u30d7<\/th><th>\u5206\u985e<\/th><th>\u898f\u5236\u3078\u306e\u5f71\u97ff<\/th><\/tr><\/thead><tbody><tr><td>\u6c4e\u7528\u6ec5\u83cc\u7dbf\u68d2<\/td><td>\u30af\u30e9\u30b9I<\/td><td>\u5b89\u5168\u6027\u3068\u6e05\u6f54\u3055\u306e\u57fa\u672c\u8981\u4ef6<\/td><\/tr><tr><td>\u9f3b\u54bd\u982d\u30b9\u30ef\u30d6\uff08COVID-19\u7528\u306a\u3069\uff09<\/td><td>\u30af\u30e9\u30b9II<\/td><td>\u53b3\u683c\u306a\u8a66\u9a13\u3001\u691c\u8a3c\u3001\u8a8d\u8a3c\u304c\u5fc5\u8981<\/td><\/tr><tr><td>\u5b50\u5bae\u9838\u90e8\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\u30d6\u30e9\u30b7<\/td><td>\u30af\u30e9\u30b9II<\/td><td>\u751f\u4f53\u9069\u5408\u6027\u8a66\u9a13\u3068\u6ec5\u83cc\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u304c\u5fc5\u8981<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"regulatory-requirements-for-manufacturers\">\u88fd\u9020\u696d\u8005\u306b\u5bfe\u3059\u308b\u898f\u5236\u8981\u4ef6<\/h3>\n\n\n\n<p>\u533b\u7642\u7528\u7dbf\u68d2\u30e1\u30fc\u30ab\u30fc\u306f\u305d\u3046\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u751f\u7523\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u306b\u308f\u305f\u3063\u3066\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3092\u7dad\u6301\u3059\u308b\u3002<\/li>\n\n\n\n<li>\u751f\u4f53\u9069\u5408\u6027\u304c\u3042\u308a\u3001\u6ec5\u83cc\u53ef\u80fd\u306a\u6750\u6599\u3092\u4f7f\u7528\u3059\u308b\u3002<\/li>\n\n\n\n<li>\u30ea\u30b9\u30af\u5206\u6790\u3001\u81e8\u5e8a\u8a55\u4fa1\u3001\u30d0\u30c3\u30c1\u30c6\u30b9\u30c8\u306b\u95a2\u3059\u308b\u6587\u66f8\u3092\u63d0\u4f9b\u3059\u308b\u3002<\/li>\n\n\n\n<li>\u898f\u5236\u6a5f\u95a2\u306b\u3088\u308b\u76e3\u67fb\u3068\u691c\u67fb\u3092\u8a31\u53ef\u3059\u308b\u3002<\/li>\n<\/ul>\n\n\n\n<p>\u30b0\u30ed\u30fc\u30d0\u30eb\u306aB2B\u30d0\u30a4\u30e4\u30fc\u306b\u3068\u3063\u3066\u3001\u3053\u308c\u3089\u306e\u5206\u985e\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u306f\u3001\u73fe\u5730\u306e\u8f38\u5165\u898f\u5236\u3068\u6574\u5408\u3055\u305b\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u9045\u308c\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u306e\u306b\u5f79\u7acb\u3064\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<figure class=\"wp-block-gallery has-nested-images columns-default is-cropped wp-block-gallery-1 is-layout-flex wp-block-gallery-is-layout-flex\">\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"800\" data-id=\"2965\" src=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Dry-Transport-SwabFlocked-Nasopharyngeal-Swab-NP-Specimen-Collection-Self-Sampling-and-TransportationC-01-3.jpg\" alt=\"\" class=\"wp-image-2965\" title=\"\" srcset=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Dry-Transport-SwabFlocked-Nasopharyngeal-Swab-NP-Specimen-Collection-Self-Sampling-and-TransportationC-01-3.jpg 800w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Dry-Transport-SwabFlocked-Nasopharyngeal-Swab-NP-Specimen-Collection-Self-Sampling-and-TransportationC-01-3-300x300.jpg 300w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Dry-Transport-SwabFlocked-Nasopharyngeal-Swab-NP-Specimen-Collection-Self-Sampling-and-TransportationC-01-3-150x150.jpg 150w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Dry-Transport-SwabFlocked-Nasopharyngeal-Swab-NP-Specimen-Collection-Self-Sampling-and-TransportationC-01-3-768x768.jpg 768w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"800\" data-id=\"2956\" src=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Cotton-Tipped-Swab-Plastic-ShaftSpecimen-CollectionCleaningMedicine-Applying-F-2.jpg\" alt=\"\" class=\"wp-image-2956\" title=\"\" srcset=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Cotton-Tipped-Swab-Plastic-ShaftSpecimen-CollectionCleaningMedicine-Applying-F-2.jpg 800w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Cotton-Tipped-Swab-Plastic-ShaftSpecimen-CollectionCleaningMedicine-Applying-F-2-300x300.jpg 300w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Cotton-Tipped-Swab-Plastic-ShaftSpecimen-CollectionCleaningMedicine-Applying-F-2-150x150.jpg 150w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Cotton-Tipped-Swab-Plastic-ShaftSpecimen-CollectionCleaningMedicine-Applying-F-2-768x768.jpg 768w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"800\" data-id=\"2958\" src=\"\u7c73\u56fd\u3067\u5378\u58f2\u9f3b\u54bd\u982d\u30b9\u30ef\u30d6\u3092\u898b\u3064\u3051\u308b\u5834\u6240\uff1aB2B\u30d0\u30a4\u30e4\u30fc\u5411\u3051\u30ac\u30a4\u30c9 - Hanheng Medical\" alt=\"\" class=\"wp-image-2958\" title=\"\" srcset=\"\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" data-srcset=\"\" \/><\/figure>\n<\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"3-top-international-certifications-for-medical-swab-manufacturers\">3.\u533b\u7642\u7528\u7dbf\u68d2\u30e1\u30fc\u30ab\u30fc\u306e\u305f\u3081\u306e\u30c8\u30c3\u30d7\u56fd\u969b\u8a8d\u8a3c<\/h2>\n\n\n\n<p>\u533b\u7642\u7528\u7dbf\u68d2\u306e\u5378\u58f2\u308a\u3084\u6d41\u901a\u306e\u305f\u3081\u306b\u6f5c\u5728\u7684\u306a\u533b\u7642\u7528\u7dbf\u68d2\u30e1\u30fc\u30ab\u30fc\u3092\u8a55\u4fa1\u3059\u308b\u969b\u3001\u30d0\u30a4\u30e4\u30fc\u306f\u56fd\u969b\u7684\u306b\u8a8d\u77e5\u3055\u308c\u305f\u8a8d\u8a3c\u3092\u6301\u3064\u4f01\u696d\u3092\u512a\u5148\u3059\u3079\u304d\u3067\u3059\u3002\u3053\u308c\u3089\u306e\u8a8d\u8a3c\u306f\u5358\u306a\u308b\u30d0\u30c3\u30b8\u3067\u306f\u306a\u304f\u3001\u30b0\u30ed\u30fc\u30d0\u30eb\u30b9\u30bf\u30f3\u30c0\u30fc\u30c9\u306b\u9069\u5408\u3057\u305f\u533b\u7642\u6d88\u8017\u54c1\u3092\u88fd\u9020\u3059\u308b\u30e1\u30fc\u30ab\u30fc\u306e\u80fd\u529b\u3092\u793a\u3059\u3082\u306e\u3067\u3042\u308b\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"essential-certifications-for-medical-swab-manufacturers\">\u533b\u7642\u7528\u7dbf\u68d2\u30e1\u30fc\u30ab\u30fc\u306b\u4e0d\u53ef\u6b20\u306a\u8a8d\u8a3c<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u8a8d\u8a3c<\/th><th>\u767a\u884c\u6a5f\u95a2<\/th><th>\u76ee\u7684<\/th><th>\u5fc5\u9808<\/th><\/tr><\/thead><tbody><tr><td><strong>ISO 13485<\/strong><\/td><td>ISO\uff08\u56fd\u969b\u6a19\u6e96\u5316\u6a5f\u69cb\uff09<\/td><td>\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0<\/td><td>\u4e16\u754c\u8cbf\u6613<\/td><\/tr><tr><td><strong>ISO 9001<\/strong><\/td><td>\u56fd\u969b\u6a19\u6e96\u5316\u6a5f\u69cb<\/td><td>\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\uff08\u5168\u822c\uff09<\/td><td>ISO13485\u306e\u88dc\u8db3<\/td><\/tr><tr><td><strong>CE\u30de\u30fc\u30ad\u30f3\u30b0<\/strong><\/td><td>\u6b27\u5dde\u59d4\u54e1\u4f1a<\/td><td>EU\u306e\u5065\u5eb7\u3001\u5b89\u5168\u3001\u74b0\u5883\u4fdd\u8b77\u57fa\u6e96\u306e\u9075\u5b88<\/td><td>EU\u5e02\u5834<\/td><\/tr><tr><td><strong>FDA 510(k)\u30af\u30ea\u30a2\u30e9\u30f3\u30b9<\/strong><\/td><td>\u7c73\u56fdFDA<\/td><td>\u30af\u30e9\u30b9II\u6a5f\u5668\u306e\u5e02\u8ca9\u524d\u5c4a\u51fa<\/td><td>\u7c73\u56fd\u5e02\u5834<\/td><\/tr><tr><td><strong>GMP\uff08\u9069\u6b63\u88fd\u9020\u898f\u7bc4\uff09<\/strong><\/td><td>WHO\/FDA\/\u73fe\u5730\u898f\u5236\u6a5f\u95a2<\/td><td>\u88fd\u54c1\u306e\u4e00\u8cab\u6027\u3068\u54c1\u8cea\u306e\u78ba\u4fdd<\/td><td>\u4e16\u754c\u306e\u88fd\u9020\u696d<\/td><\/tr><tr><td><strong>NMPA\u767b\u9332<\/strong><\/td><td>\u4e2d\u56fd\u306e\u76e3\u7763\u5b98\u5e81<\/td><td>\u56fd\u5185\u6d41\u901a\u8a8d\u8a3c<\/td><td>\u4e2d\u56fd<\/td><\/tr><tr><td><strong>\u751f\u4f53\u9069\u5408\u6027\u8a66\u9a13 (ISO 10993)<\/strong><\/td><td>\u30b5\u30fc\u30c9\u30d1\u30fc\u30c6\u30a3\u306e\u30e9\u30dc<\/td><td>\u30d2\u30c8\u7d44\u7e54\u3068\u306e\u5b89\u5168\u306a\u76f8\u4e92\u4f5c\u7528\u3092\u78ba\u8a8d<\/td><td>\u30b0\u30ed\u30fc\u30d0\u30eb\u30d0\u30a4\u30e4\u30fc<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"what-each-certification-covers\">\u5404\u8a8d\u5b9a\u8cc7\u683c\u306e\u5185\u5bb9<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>ISO13485\uff1a<\/strong> \u30ea\u30b9\u30af\u7ba1\u7406\u3001\u6587\u66f8\u7ba1\u7406\u3001\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u306b\u91cd\u70b9\u3092\u7f6e\u3044\u3066\u3044\u308b\u3002<\/li>\n\n\n\n<li><strong>CE\u30de\u30fc\u30ad\u30f3\u30b0\uff1a<\/strong> \u88fd\u54c1\u304cEU\u57df\u5185\u3067\u5b89\u5168\u306b\u4f7f\u7528\u3067\u304d\u3001\u74b0\u5883\u30fb\u885b\u751f\u57fa\u6e96\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3002<\/li>\n\n\n\n<li><strong>FDA 510(k)\uff1a<\/strong> \u88fd\u54c1\u304c\u3059\u3067\u306b\u627f\u8a8d\u3055\u308c\u305f\u6a5f\u5668\u3068\u5b9f\u8cea\u7684\u306b\u540c\u7b49\u3067\u3042\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u3002<\/li>\n\n\n\n<li><strong>GMP\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\uff1a<\/strong> \u88fd\u9020\u5de5\u7a0b\u304c\u4e00\u8cab\u3057\u3066\u54c1\u8cea\u57fa\u6e96\u3092\u6e80\u305f\u3059\u88fd\u54c1\u3092\u751f\u7523\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u691c\u8a3c\u3059\u308b\u3002<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"why-b2b-buyers-should-insist-on-certified-suppliers\">B2B\u30d0\u30a4\u30e4\u30fc\u304c\u8a8d\u5b9a\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3092\u4e3b\u5f35\u3059\u3079\u304d\u7406\u7531<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u8cac\u4efb\u306e\u8efd\u6e1b\uff1a<\/strong> \u898f\u683c\u5916\u88fd\u54c1\u306b\u8d77\u56e0\u3059\u308b\u6cd5\u7684\u554f\u984c\u3084\u5065\u5eb7\u554f\u984c\u3092\u56de\u907f\u3059\u308b\u3002<\/li>\n\n\n\n<li><strong>\u30a4\u30f3\u30dd\u30fc\u30c8\u30d7\u30ed\u30bb\u30b9\u306e\u5408\u7406\u5316\uff1a<\/strong> \u8a8d\u8a3c\u3055\u308c\u305f\u88fd\u54c1\u306f\u3001\u7a0e\u95a2\u3084\u898f\u5236\u5f53\u5c40\u306e\u30c1\u30a7\u30c3\u30af\u3092\u3088\u308a\u65e9\u304f\u901a\u904e\u3059\u308b\u3002<\/li>\n\n\n\n<li><strong>\u533b\u7642\u5f93\u4e8b\u8005\u304b\u3089\u306e\u4fe1\u983c<\/strong> \u75c5\u9662\u3084\u7814\u7a76\u6240\u306f\u3001\u81e8\u5e8a\u7528\u3068\u3057\u3066\u8a8d\u8a3c\u3055\u308c\u305f\u88fd\u54c1\u3092\u597d\u3080\u3002<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"4-why-iso-13485-is-essential-for-medical-swab-suppliers\">4.\u533b\u7642\u7528\u7dbf\u68d2\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306b\u3068\u3063\u3066ISO 13485\u304c\u4e0d\u53ef\u6b20\u306a\u7406\u7531<\/h2>\n\n\n\n<p>ISO 13485\u306f\u3001\u8a3a\u65ad\u3084\u81e8\u5e8a\u73fe\u5834\u3067\u4f7f\u7528\u3055\u308c\u308b\u7dbf\u68d2\u3092\u542b\u3080\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u5411\u3051\u306b\u7279\u5225\u306b\u8a2d\u8a08\u3055\u308c\u305f\u3001\u6700\u3082\u91cd\u8981\u306a\u56fd\u969b\u898f\u683c\u3067\u3059\u3002B2B\u30d0\u30a4\u30e4\u30fc\u3001\u7279\u306b\u75c5\u9662\u3001\u8a3a\u65ad\u30e9\u30dc\u3001\u6d41\u901a\u30cd\u30c3\u30c8\u30ef\u30fc\u30af\u5411\u3051\u306b\u5378\u58f2\u308a\u6570\u91cf\u3092\u8abf\u9054\u3059\u308b\u30d0\u30a4\u30e4\u30fc\u306b\u3068\u3063\u3066\u3001ISO 13485\u8a8d\u5b9a\u30e1\u30fc\u30ab\u30fc\u3068\u306e\u53d6\u5f15\u306f\u3001\u3088\u308a\u9ad8\u3044\u30ec\u30d9\u30eb\u306e\u5b89\u5168\u6027\u3001\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3001\u898f\u5236\u9075\u5b88\u3092\u4fdd\u8a3c\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"what-is-iso-13485\">ISO13485\u3068\u306f\uff1f<\/h3>\n\n\n\n<p>ISO13485:2016\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u3001\u958b\u767a\u3001\u88fd\u9020\u3001\u8ca9\u58f2\u306b\u95a2\u3059\u308b\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\uff08QMS\uff09\u898f\u683c\u3068\u3057\u3066\u56fd\u969b\u7684\u306b\u8a8d\u77e5\u3055\u308c\u3066\u3044\u308b\u3002ISO9001\u306b\u306f\u306a\u3044\u533b\u7642\u6a5f\u5668\u7279\u6709\u306e\u8981\u6c42\u4e8b\u9805\u304c\u76db\u308a\u8fbc\u307e\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"key-iso-13485-features-for-medical-swab-manufacturers\">\u533b\u7642\u7528\u7dbf\u68d2\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u306eISO 13485\u306e\u4e3b\u306a\u7279\u5fb4<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u7279\u5fb4<\/th><th>\u8aac\u660e<\/th><\/tr><\/thead><tbody><tr><td><strong>\u30ea\u30b9\u30af\u7ba1\u7406<\/strong><\/td><td>\u88fd\u9020\u306e\u5404\u6bb5\u968e\u3067\u30ea\u30b9\u30af\u5206\u6790\u3092\u7fa9\u52d9\u4ed8\u3051\u308b\u3002<\/td><\/tr><tr><td><strong>\u88fd\u54c1\u306e\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3<\/strong><\/td><td>\u30ea\u30b3\u30fc\u30eb\u3084\u76e3\u67fb\u306b\u4e0d\u53ef\u6b20\u306a\u5b8c\u5168\u306a\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u306e\u305f\u3081\u306e\u30d0\u30c3\u30c1\u30ec\u30d9\u30eb\u306e\u6587\u66f8\u5316\u3002<\/td><\/tr><tr><td><strong>\u8a2d\u8a08\u691c\u8a3c\u3068\u59a5\u5f53\u6027\u78ba\u8a8d<\/strong><\/td><td>\u5404\u88fd\u54c1\u304c\u6a5f\u80fd\u6027\u3068\u5b89\u5168\u6027\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3002<\/td><\/tr><tr><td><strong>\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u7ba1\u7406<\/strong><\/td><td>\u88fd\u9020\u696d\u8005\u306b\u5bfe\u3057\u3001\u3059\u3079\u3066\u306e\u90e8\u54c1\u4f9b\u7d66\u696d\u8005\u3092\u78ba\u8a8d\u3057\u3001\u9069\u683c\u6027\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u3092\u7fa9\u52d9\u4ed8\u3051\u308b\u3002<\/td><\/tr><tr><td><strong>\u6ec5\u83cc\u30d7\u30ed\u30bb\u30b9\u7ba1\u7406<\/strong><\/td><td>EO\u3001\u30ac\u30f3\u30de\u7dda\u306a\u3069\u306e\u6709\u52b9\u306a\u6ec5\u83cc\u65b9\u6cd5\u306e\u30d7\u30ed\u30c8\u30b3\u30eb\u3002<\/td><\/tr><tr><td><strong>\u82e6\u60c5\u51e6\u7406\u3068CAPA<\/strong><\/td><td>\u662f\u6b63\u63aa\u7f6e\u304a\u3088\u3073\u4e88\u9632\u63aa\u7f6e\u306e\u305f\u3081\u306e\u30b7\u30b9\u30c6\u30e0\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"benefits-of-iso-13485-for-b2b-buyers\">B2B\u30d0\u30a4\u30e4\u30fc\u306b\u3068\u3063\u3066\u306eISO 13485\u306e\u30e1\u30ea\u30c3\u30c8<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u4fe1\u983c\u3067\u304d\u308b\u54c1\u8cea\u4fdd\u8a3c\uff1a<\/strong> \u88fd\u54c1\u306e\u6b20\u9665\u3084\u4e0d\u6574\u5408\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u307e\u3059\u3002<\/li>\n\n\n\n<li><strong>\u898f\u5236\u306e\u6e96\u5099\uff1a<\/strong> FDA\u304a\u3088\u3073EU MDR\u3092\u542b\u3080\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u898f\u5236\u8981\u4ef6\u306b\u9069\u5408\u3002<\/li>\n\n\n\n<li><strong>\u3088\u308a\u826f\u3044\u30c9\u30ad\u30e5\u30e1\u30f3\u30c6\u30fc\u30b7\u30e7\u30f3\uff1a<\/strong> \u76e3\u67fb\u3084\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30fb\u30ec\u30d3\u30e5\u30fc\u3092\u5186\u6ed1\u306b\u9032\u3081\u308b\u3002<\/li>\n\n\n\n<li><strong>\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u30fb\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u6539\u5584\uff1a<\/strong> \u8a8d\u8a3c\u3092\u53d7\u3051\u305f\u88fd\u9020\u696d\u8005\u306f\u3001\u539f\u6750\u6599\u4f9b\u7d66\u696d\u8005\u3082\u76e3\u67fb\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"example-jiangsu-hanheng-medical-technology-co-ltd\">\u4f8b\u6c5f\u8607\u6f22\u6052\u533b\u7642\u6280\u8853\u6709\u9650\u516c\u53f8<\/h3>\n\n\n\n<p>\u6c5f\u8607\u6f22\u6052\u306fISO13485\u8a8d\u8a3c\u3092\u53d6\u5f97\u3057\u3001\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u8f38\u51fa\u6226\u7565\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u8a8d\u8a3c\u306f\u3001Hanheng\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u3059\u3079\u3066\u306e\u88fd\u9020\u6bb5\u968e\u306b\u304a\u3044\u3066\u53b3\u683c\u306a\u54c1\u8cea\u7ba1\u7406\u3092\u7dad\u6301\u3059\u308b\u3002<\/li>\n\n\n\n<li>\u88fd\u54c1\u30e9\u30a4\u30f3\uff08\u30b9\u30ef\u30d6\u3001\u5b50\u5bae\u9838\u90e8\u30d6\u30e9\u30b7\u3001\u30b5\u30f3\u30d7\u30eb\u30b3\u30ec\u30af\u30bf\u30fc\u306a\u3069\uff09\u3067\u4e00\u8cab\u3057\u305f\u88fd\u54c1\u54c1\u8cea\u3092\u78ba\u4fdd\u3059\u308b\u3002<\/li>\n\n\n\n<li>\u5404\u30d0\u30c3\u30c1\u306e\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30fb\u30b7\u30b9\u30c6\u30e0\u304c\u3042\u308a\u3001\u6d41\u901a\u696d\u8005\u3084\u30d0\u30a4\u30e4\u30fc\u306e\u6587\u66f8\u5316\u3084\u54c1\u8cea\u7ba1\u7406\u306b\u5f79\u7acb\u3063\u3066\u3044\u308b\u3002<\/li>\n<\/ul>\n\n\n\n<p>\u3053\u306e\u305f\u3081Hanheng\u306f\u3001\u4fe1\u983c\u3067\u304d\u308b\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306b\u6e96\u62e0\u3057\u305f\u4e2d\u56fd\u304b\u3089\u306e\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3092\u6c42\u3081\u308b\u533b\u7642\u8ca9\u58f2\u696d\u8005\u3084\u8a3a\u65ad\u30e9\u30dc\u306b\u3068\u3063\u3066\u7406\u60f3\u7684\u306a\u30d1\u30fc\u30c8\u30ca\u30fc\u3068\u306a\u3063\u3066\u3044\u308b\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<figure class=\"wp-block-embed aligncenter is-type-wp-embed is-provider-hanheng-medical wp-block-embed-hanheng-medical\"><div class=\"wp-block-embed__wrapper\">\n<blockquote class=\"wp-embedded-content\" data-secret=\"drMjNAqPW5\"><a href=\"https:\/\/hanheng-medical.com\/ja\/product\/nylon-flocked-swab-nasal-specimen-collection-various-samping-site-a-010\/\">\u30ca\u30a4\u30ed\u30f3\u30d5\u30ed\u30c3\u30af\u30b9\u30ef\u30d6\/\u9f3b\u8154\u691c\u4f53\u63a1\u53d6\/\u5404\u7a2e\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\u90e8\u4f4d A-010<\/a><\/blockquote><iframe loading=\"lazy\" class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; visibility: hidden;\" title=\"\u300c\u30ca\u30a4\u30ed\u30f3\u30d5\u30ed\u30c3\u30af\u30b9\u30ef\u30d6\/\u9f3b\u8154\u691c\u4f53\u63a1\u53d6\/\u5404\u7a2e\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\u30b5\u30a4\u30c8 A-010&quot; - Hanheng Medical\" src=\"https:\/\/hanheng-medical.com\/product\/nylon-flocked-swab-nasal-specimen-collection-various-samping-site-a-010\/embed\/#?secret=JIuEIFAfsG#?secret=drMjNAqPW5\" data-secret=\"drMjNAqPW5\" 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\" id=\"5-fda-and-ce-marking-critical-certifications-for-global-distribution\">5.FDA\u3068CE\u30de\u30fc\u30ad\u30f3\u30b0\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u6d41\u901a\u306b\u4e0d\u53ef\u6b20\u306a\u8a8d\u8a3c<\/h2>\n\n\n\n<p>\u7c73\u56fd\u3084\u6b27\u5dde\u9023\u5408\uff08EU\uff09\u306e\u5e02\u5834\u3092\u30bf\u30fc\u30b2\u30c3\u30c8\u3068\u3059\u308b\u533b\u7642\u7528\u7dbf\u68d2\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u3001FDA\u8a8d\u53ef\u3084CE\u30de\u30fc\u30ad\u30f3\u30b0\u306e\u53d6\u5f97\u306f\u6709\u76ca\u3067\u3042\u308b\u3060\u3051\u3067\u306a\u304f\u3001\u5fc5\u8981\u4e0d\u53ef\u6b20\u3067\u3059\u3002\u3053\u308c\u3089\u306e\u8a8d\u8a3c\u306f\u3001\u88fd\u54c1\u306e\u5b89\u5168\u6027\u3001\u6709\u52b9\u6027\u3001\u898f\u5236\u3078\u306e\u9069\u5408\u6027\u3092\u8a3c\u660e\u3059\u308b\u3082\u306e\u3067\u3042\u308a\u3001\u3053\u308c\u3089\u306e\u5730\u57df\u3067\u306e\u5408\u6cd5\u7684\u306a\u8ca9\u58f2\u3068\u6d41\u901a\u3092\u53ef\u80fd\u306b\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"fda-510-k-clearance-for-medical-swabs\">\u533b\u7642\u7528\u7dbf\u68d2\u306eFDA 510(k)\u30af\u30ea\u30a2\u30e9\u30f3\u30b9<\/h3>\n\n\n\n<p>\u7c73\u56fd\u3067\u306f\u3001\u8a3a\u65ad\u7528\u7dbf\u68d2\u306e\u307b\u3068\u3093\u3069\u304c\u30af\u30e9\u30b9I\u307e\u305f\u306f\u30af\u30e9\u30b9II\u306e\u533b\u7642\u6a5f\u5668\u306b\u8a72\u5f53\u3059\u308b\u3002\u30af\u30e9\u30b9II\u533b\u7642\u6a5f\u5668\u306e\u5834\u5408\u3001\u88fd\u9020\u696d\u8005\u306fFDA\u306b510(k)\u5e02\u8ca9\u524d\u5c4a\u51fa\u3092\u63d0\u51fa\u3057\u3001\u305d\u306e\u88fd\u54c1\u304c\u6cd5\u7684\u306b\u5e02\u8ca9\u3055\u308c\u3066\u3044\u308b\u533b\u7642\u6a5f\u5668\u3068\u300c\u5b9f\u8cea\u7684\u306b\u540c\u7b49\u300d\u3067\u3042\u308b\u3053\u3068\u3092\u8a3c\u660e\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"what-fda-510-k-involves\">FDA 510(k)\u306e\u5185\u5bb9<\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u30c6\u30b9\u30c8\uff1a<\/strong> \u5438\u53ce\u6027\u3001\u30c1\u30c3\u30d7\u306e\u5f37\u5ea6\u3001\u691c\u67fb\u8a66\u85ac\u3068\u306e\u9069\u5408\u6027\u3092\u542b\u3080\u3002<\/li>\n\n\n\n<li><strong>\u7121\u83cc\u6027\u306e\u691c\u8a3c\uff1a<\/strong> \u7dbf\u68d2\u306b\u751f\u5b58\u53ef\u80fd\u306a\u5fae\u751f\u7269\u304c\u3044\u306a\u3044\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3002<\/li>\n\n\n\n<li><strong>\u751f\u4f53\u9069\u5408\u6027\u8a66\u9a13\uff1a<\/strong> \u7d30\u80de\u6bd2\u6027\u3001\u611f\u4f5c\u6027\u3001\u523a\u6fc0\u6027\u3092\u8a55\u4fa1\u3059\u308b\u3002<\/li>\n\n\n\n<li><strong>\u30e9\u30d9\u30ea\u30f3\u30b0\u306e\u898b\u76f4\u3057\uff1a<\/strong> FDA\u306f\u3001\u9069\u5207\u306a\u8aac\u660e\u66f8\u3068\u4f7f\u7528\u76ee\u7684\u306e\u8a18\u8ff0\u3092\u30c1\u30a7\u30c3\u30af\u3059\u308b\u3002<\/li>\n\n\n\n<li><strong>\u88fd\u9020\u691c\u67fb\uff1a<\/strong> FDA\u306fGMP\u9075\u5b88\u306e\u305f\u3081\u306b\u751f\u7523\u65bd\u8a2d\u3092\u67fb\u5bdf\u3059\u308b\u3053\u3068\u304c\u3042\u308b\u3002<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"ce-marking-for-european-market-access\">\u6b27\u5dde\u5e02\u5834\u53c2\u5165\u306e\u305f\u3081\u306eCE\u30de\u30fc\u30ad\u30f3\u30b0<\/h3>\n\n\n\n<p>CE\u30de\u30fc\u30ad\u30f3\u30b0\u306f\u3001\u6b27\u5dde\u7d4c\u6e08\u5730\u57df\uff08EEA\uff09\u3067\u8ca9\u58f2\u3055\u308c\u308b\u88fd\u54c1\u306b\u5bfe\u3057\u3066\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u308b\u9069\u5408\u30de\u30fc\u30af\u3067\u3059\u3002\u533b\u7642\u6a5f\u5668\u304cEU\u306e\u5b89\u5168\u3001\u885b\u751f\u3001\u74b0\u5883\u4fdd\u8b77\u306b\u95a2\u3059\u308b\u8981\u6c42\u4e8b\u9805\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u3059\u3082\u306e\u3067\u3059\u3002<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"key-requirements-for-ce-marking\">CE\u30de\u30fc\u30ad\u30f3\u30b0\u306e\u4e3b\u306a\u8981\u4ef6<\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u6280\u8853\u6587\u66f8\uff1a<\/strong> \u88fd\u54c1\u4ed5\u69d8\u66f8\u3001\u30ea\u30b9\u30af\u5206\u6790\u3001\u8a66\u9a13\u5831\u544a\u66f8\u3002<\/li>\n\n\n\n<li><strong>\u81e8\u5e8a\u8a55\u4fa1\uff1a<\/strong> \u30b9\u30ef\u30d6\u304c\u610f\u56f3\u3055\u308c\u305f\u7528\u9014\u306b\u304a\u3044\u3066\u52b9\u679c\u7684\u306b\u6a5f\u80fd\u3059\u308b\u3053\u3068\u3092\u793a\u3059\u8a3c\u62e0\u3002<\/li>\n\n\n\n<li><strong>\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u76e3\u67fb\uff1a<\/strong> \u901a\u5e38\u3001\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30fb\u30dc\u30c7\u30a3\u304cISO 13485\u3078\u306e\u9069\u5408\u6027\u3092\u691c\u8a3c\u3059\u308b\u3002<\/li>\n\n\n\n<li><strong>\u9069\u5408\u5ba3\u8a00\uff1a<\/strong> \u88fd\u54c1\u304c\u95a2\u9023\u3059\u308bEU\u6307\u4ee4\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u3059\u88fd\u9020\u8005\u306e\u7f72\u540d\u5165\u308a\u6587\u66f8\u3002<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"why-these-certifications-matter-for-b2b-buyers\">B2B\u30d0\u30a4\u30e4\u30fc\u306b\u3068\u3063\u3066\u3053\u308c\u3089\u306e\u8a8d\u8a3c\u304c\u91cd\u8981\u306a\u7406\u7531<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8<\/th><th>FDA\u30af\u30ea\u30a2\u30e9\u30f3\u30b9<\/th><th>CE\u30de\u30fc\u30ad\u30f3\u30b0<\/th><\/tr><\/thead><tbody><tr><td><strong>\u6cd5\u7684\u6d41\u901a<\/strong><\/td><td>\u7c73\u56fd\u3067\u306f\u5fc5\u9808<\/td><td>EU\u3067\u5fc5\u8981<\/td><\/tr><tr><td><strong>\u5e02\u5834\u30a2\u30af\u30bb\u30b9<\/strong><\/td><td>\u6a5f\u95a2\u8cfc\u8cb7\u3092\u53ef\u80fd\u306b\u3059\u308b<\/td><td>\u653f\u5e9c\u306e\u5165\u672d\u3092\u53ef\u80fd\u306b\u3059\u308b<\/td><\/tr><tr><td><strong>\u30ea\u30b9\u30af\u306e\u4f4e\u6e1b<\/strong><\/td><td>\u9023\u90a6\u898f\u5236\u306e\u9075\u5b88\u306e\u78ba\u4fdd<\/td><td>EU MDR\u306b\u6e96\u62e0<\/td><\/tr><tr><td><strong>\u30d6\u30e9\u30f3\u30c9\u306e\u4fe1\u983c\u6027<\/strong><\/td><td>\u7c73\u56fd\u306e\u75c5\u9662\u3084\u7814\u7a76\u6240\u304b\u3089\u4fe1\u983c\u3055\u308c\u3066\u3044\u308b<\/td><td>EU\u306e\u533b\u7642\u5236\u5ea6\u3067\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u308b<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"hanheng-s-compliance-with-fda-and-ce\">\u30cf\u30f3\u30d8\u30f3\u306eFDA\u304a\u3088\u3073CE\u3078\u306e\u6e96\u62e0<\/h3>\n\n\n\n<p>Jiangsu Hanheng Medical Technology Co., Ltd.\u306f\u3001\u533b\u7642\u7528\u7dbf\u68d2\u304a\u3088\u3073\u8a3a\u65ad\u7528\u6d88\u8017\u54c1\u306e\u88fd\u54c1\u30e9\u30a4\u30f3\u306b\u3064\u3044\u3066CE\u304a\u3088\u3073FDA\u306e\u4e21\u8a8d\u8a3c\u3092\u53d6\u5f97\u3057\u3066\u304a\u308a\u3001\u30b0\u30ed\u30fc\u30d0\u30eb\u30d0\u30a4\u30e4\u30fc\u306b\u3068\u3063\u3066\u4fe1\u983c\u3067\u304d\u308b\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u4e8c\u91cd\u8a8d\u8a3c\u306b\u3088\u308a\u3001\u4ee5\u4e0b\u306e\u3053\u3068\u304c\u4fdd\u8a3c\u3055\u308c\u307e\u3059\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u6b27\u7c73\u5e02\u5834\u3078\u306e\u4e0d\u65ad\u306e\u30a2\u30af\u30bb\u30b9\u3002<\/strong><\/li>\n\n\n\n<li><strong>\u7a0e\u95a2\u3084\u898f\u5236\u5f53\u5c40\u306e\u76e3\u67fb\u306b\u5229\u7528\u53ef\u80fd\u306a\u898f\u5236\u6587\u66f8\u3002<\/strong><\/li>\n\n\n\n<li><strong>\u4e16\u754c\u4e2d\u306e\u75c5\u9662\u3001\u8a3a\u65ad\u30bb\u30f3\u30bf\u30fc\u3001\u516c\u8846\u885b\u751f\u6a5f\u95a2\u306b\u53d7\u3051\u5165\u308c\u3089\u308c\u3066\u3044\u308b\u88fd\u54c1\u3002<\/strong><\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"6-how-certified-manufacturers-ensure-quality-and-safety\">6.\u8a8d\u5b9a\u30e1\u30fc\u30ab\u30fc\u304c\u54c1\u8cea\u3068\u5b89\u5168\u6027\u3092\u78ba\u4fdd\u3059\u308b\u65b9\u6cd5<\/h2>\n\n\n\n<p>\u4e00\u6d41\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u5358\u306b\u8a8d\u8a3c\u3092\u53d6\u5f97\u3059\u308b\u3060\u3051\u3067\u306a\u304f\u3001\u54c1\u8cea\u3068\u5b89\u5168\u6027\u3092\u696d\u52d9\u306e\u3042\u3089\u3086\u308b\u5074\u9762\u306b\u7d44\u307f\u8fbc\u3093\u3067\u3044\u307e\u3059\u3002ISO 13485\u3001FDA\u8a8d\u53ef\u3001CE\u30de\u30fc\u30ad\u30f3\u30b0\u306a\u3069\u306e\u8a8d\u8a3c\u306f\u3001\u4e00\u5ea6\u3060\u3051\u306e\u76e3\u67fb\u3067\u306f\u306a\u304f\u3001\u7d99\u7d9a\u7684\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u8981\u6c42\u3057\u307e\u3059\u3002\u3064\u307e\u308a\u3001\u539f\u6750\u6599\u306e\u8abf\u9054\u304b\u3089\u6700\u7d42\u5305\u88c5\u306b\u81f3\u308b\u307e\u3067\u3001\u88fd\u9020\u30a8\u30b3\u30b7\u30b9\u30c6\u30e0\u5168\u4f53\u304c\u53b3\u3057\u3044\u56fd\u969b\u57fa\u6e96\u3092\u6e80\u305f\u3059\u3088\u3046\u306b\u8a2d\u8a08\u3055\u308c\u3066\u3044\u308b\u306e\u3067\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"key-quality-control-practices-used-by-certified-manufacturers\">\u8a8d\u5b9a\u30e1\u30fc\u30ab\u30fc\u304c\u63a1\u7528\u3057\u3066\u3044\u308b\u4e3b\u306a\u54c1\u8cea\u7ba1\u7406\u6163\u884c<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u54c1\u8cea\u7ba1\u7406\u8981\u7d20<\/th><th>\u8aac\u660e<\/th><\/tr><\/thead><tbody><tr><td><strong>\u75c5\u9662\u304a\u3088\u3073\u516c\u8846\u885b\u751f\u6a5f\u95a2<\/strong><\/td><td>\u30af\u30e9\u30b9100,000\u306e\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u306f\u3001\u88fd\u9020\u4e2d\u306e\u6c5a\u67d3\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u307e\u3059\u3002<\/td><\/tr><tr><td><strong>\u6ec5\u83cc\u30d7\u30ed\u30c8\u30b3\u30eb<\/strong><\/td><td>EO\u30ac\u30b9\u6ec5\u83cc\u3001\u30ac\u30f3\u30de\u7dda\u6ec5\u83cc\u3001\u84b8\u6c17\u6ec5\u83cc\u306f\u3001\u88fd\u54c1\u306e\u7a2e\u985e\u3054\u3068\u306b\u6709\u52b9\u3067\u3042\u308b\u3002<\/td><\/tr><tr><td><strong>\u30d0\u30c3\u30c1\u30c6\u30b9\u30c8<\/strong><\/td><td>\u6027\u80fd\u3001\u7121\u83cc\u6027\u3001\u6a5f\u68b0\u7684\u5b8c\u5168\u6027\u306b\u95a2\u3059\u308b\u7d71\u8a08\u7684\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\u3002<\/td><\/tr><tr><td><strong>\u74b0\u5883\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0<\/strong><\/td><td>\u7a7a\u6c17\u306e\u8cea\u3001\u6e7f\u5ea6\u3001\u5fae\u7c92\u5b50\u30ec\u30d9\u30eb\u3092\u7d99\u7d9a\u7684\u306b\u76e3\u8996\u3002<\/td><\/tr><tr><td><strong>\u6750\u6599\u306e\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3<\/strong><\/td><td>\u6a39\u8102\u3001\u30d5\u30ed\u30c3\u30ad\u30f3\u30b0\u3001\u63a5\u7740\u5264\u306f\u5143\u306e\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306b\u9061\u308b\u3002<\/td><\/tr><tr><td><strong>\u6587\u66f8\u5316\u3055\u308c\u305fSOP<\/strong><\/td><td>\u5404\u751f\u7523\u5de5\u7a0b\u306e\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\u3092\u4f5c\u6210\u3057\u3001\u4e00\u8cab\u6027\u3092\u78ba\u4fdd\u3059\u308b\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"certified-facilities-a-snapshot-of-hanheng-s-manufacturing-capabilities\">\u8a8d\u5b9a\u65bd\u8a2d\uff1a\u30cf\u30f3\u30d8\u30f3\u306e\u88fd\u9020\u80fd\u529b\u306e\u30b9\u30ca\u30c3\u30d7\u30b7\u30e7\u30c3\u30c8<\/h3>\n\n\n\n<p>\u6c5f\u8607\u6f22\u6052\u533b\u7642\u79d1\u6280\u6709\u9650\u516c\u53f8\u306f\u300110,000\u33a1\u306e\u30af\u30e9\u30b9100,000\u8a8d\u8a3c\u306e\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u65bd\u8a2d\u3092\u904b\u55b6\u3057\u3001\u88fd\u9020\u306e\u305f\u3081\u306e\u7121\u83cc\u72b6\u614b\u3092\u78ba\u4fdd\u3057\u3066\u3044\u307e\u3059\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u9f3b\u3068\u5589\u306e\u7dbf\u68d2<\/li>\n\n\n\n<li>\u5b50\u5bae\u9838\u90e8\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\u30d6\u30e9\u30b7<\/li>\n\n\n\n<li>\u4f7f\u3044\u6368\u3066\u5b50\u5bae\u9838\u90e8\u30b5\u30f3\u30d7\u30eb\u30b3\u30ec\u30af\u30bf\u30fc<\/li>\n\n\n\n<li>\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\u30fb\u30c1\u30e5\u30fc\u30d6\u304a\u3088\u3073\u30dc\u30c3\u30af\u30b9<\/li>\n<\/ul>\n\n\n\n<p>Hanheng\u306e\u65bd\u8a2d\u306fISO 13485\u306b\u5b8c\u5168\u306b\u6e96\u62e0\u3057\u3066\u304a\u308a\u3001\u3059\u3079\u3066\u306e\u88fd\u9020\u6bb5\u968e\u306b\u304a\u3044\u3066GMP\u6a19\u6e96\u306b\u5f93\u3063\u3066\u3044\u307e\u3059\u3002\u9ad8\u5ea6\u306a\u74b0\u5883\u5236\u5fa1\u3068\u81ea\u52d5\u5316\u3055\u308c\u305f\u751f\u7523\u30e9\u30a4\u30f3\u306b\u3088\u308a\u3001\u8a3a\u65ad\u7cbe\u5ea6\u306b\u4e0d\u53ef\u6b20\u306a\u4eba\u70ba\u7684\u30df\u30b9\u3068\u6c5a\u67d3\u30ea\u30b9\u30af\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"how-b2b-buyers-benefit-from-certified-quality-systems\">B2B\u30d0\u30a4\u30e4\u30fc\u304c\u8a8d\u8a3c\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u304b\u3089\u6069\u6075\u3092\u53d7\u3051\u308b\u65b9\u6cd5<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u88fd\u54c1\u4e0d\u826f\u306e\u6e1b\u5c11\uff1a<\/strong> \u30c7\u30a3\u30b9\u30c8\u30ea\u30d3\u30e5\u30fc\u30bf\u30fc\u306e\u30b3\u30b9\u30c8\u3068\u30ec\u30d4\u30e5\u30c6\u30fc\u30b7\u30e7\u30f3\u30fb\u30ea\u30b9\u30af\u3092\u8efd\u6e1b\u3002<\/li>\n\n\n\n<li><strong>\u3088\u308a\u826f\u3044\u8cde\u5473\u671f\u9650\u3068\u5305\u88c5\uff1a<\/strong> \u8a8d\u5b9a\u3092\u53d7\u3051\u305f\u88fd\u9020\u696d\u8005\u306f\u3001\u53b3\u683c\u306a\u5305\u88c5\u30fb\u5bc6\u5c01\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u5f93\u3046\u3002<\/li>\n\n\n\n<li><strong>\u898f\u5236\u30ea\u30b9\u30af\u306e\u4f4e\u6e1b\uff1a<\/strong> \u7a0e\u95a2\u691c\u67fb\u3084\u76e3\u67fb\u306b\u5408\u683c\u3057\u3084\u3059\u304f\u306a\u308b\u3002<\/li>\n\n\n\n<li><strong>\u3088\u308a\u9ad8\u3044\u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u6e80\u8db3\u5ea6\uff1a<\/strong> \u533b\u7642\u95a2\u4fc2\u8005\u306f\u8a8d\u8a3c\u88fd\u54c1\u3092\u4fe1\u983c\u3057\u3001\u4f7f\u7528\u7387\u3068\u518d\u6ce8\u6587\u306e\u53ef\u80fd\u6027\u3092\u5411\u4e0a\u3055\u305b\u3066\u3044\u308b\u3002<\/li>\n<\/ul>\n\n\n\n<figure class=\"wp-block-embed aligncenter is-type-wp-embed is-provider-hanheng-medical wp-block-embed-hanheng-medical\"><div class=\"wp-block-embed__wrapper\">\n<blockquote class=\"wp-embedded-content\" data-secret=\"wJbZiOkEel\"><a href=\"https:\/\/hanheng-medical.com\/ja\/product\/nylon-flocked-swab-specimen-colletion-various-samping-site-a-012\/\">\u30ca\u30a4\u30ed\u30f3\u30d5\u30ed\u30c3\u30af\u30b9\u30ef\u30d6\/\u691c\u4f53\u63a1\u53d6\/\u5404\u7a2e\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\u30b5\u30a4\u30c8 A-012<\/a><\/blockquote><iframe loading=\"lazy\" class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; visibility: hidden;\" title=\"\u300c\u30ca\u30a4\u30ed\u30f3\u30d5\u30ed\u30c3\u30af\u30b9\u30ef\u30d6\/\u691c\u4f53\u63a1\u53d6\/\u69d8\u3005\u306a\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\u30b5\u30a4\u30c8A-012&quot; - Hanheng Medical\" src=\"https:\/\/hanheng-medical.com\/product\/nylon-flocked-swab-specimen-colletion-various-samping-site-a-012\/embed\/#?secret=yMbaQYDBGv#?secret=wJbZiOkEel\" data-secret=\"wJbZiOkEel\" 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\" id=\"7-top-certified-medical-swab-manufacturers-worldwide-including-hanheng-in-china\">7.\u4e16\u754c\u306e\u533b\u7642\u7528\u7dbf\u68d2\u30c8\u30c3\u30d7\u8a8d\u5b9a\u30e1\u30fc\u30ab\u30fc\uff08\u4e2d\u56fd\u306eHanheng\u3092\u542b\u3080\uff09<\/h2>\n\n\n\n<p>B2B\u30d0\u30a4\u30e4\u30fc\u306b\u3068\u3063\u3066\u3001\u9069\u5207\u306a\u533b\u7642\u7528\u7dbf\u68d2\u30e1\u30fc\u30ab\u30fc\u3092\u9078\u629e\u3059\u308b\u3053\u3068\u306f\u3001\u4fa1\u683c\u3060\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u75c5\u9662\u3001\u8a3a\u65ad\u30e9\u30dc\u3001\u56fd\u5bb6\u4fdd\u5065\u30d7\u30ed\u30b0\u30e9\u30e0\u5411\u3051\u306b\u8abf\u9054\u3059\u308b\u5834\u5408\u3001\u8a8d\u8a3c\u3001\u54c1\u8cea\u4fdd\u8a3c\u3001\u751f\u7523\u80fd\u529b\u306f\u4e0d\u53ef\u6b20\u3067\u3059\u3002\u3053\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u3067\u306f\u3001\u4e16\u754c\u306e\u4e3b\u8981\u306a\u8a8d\u8a3c\u533b\u7642\u7528\u7dbf\u68d2\u30e1\u30fc\u30ab\u30fc\u3092\u30ea\u30b9\u30c8\u30a2\u30c3\u30d7\u3057\u3001\u7279\u306b\u4ee5\u4e0b\u306e\u30e1\u30fc\u30ab\u30fc\u306b\u30b9\u30dd\u30c3\u30c8\u30e9\u30a4\u30c8\u3092\u5f53\u3066\u307e\u3059\u3002<a href=\"https:\/\/hanheng-medical.com\/ja\/about-us\/\"> \u6c5f\u8607\u6f22\u6052\u533b\u7642\u6280\u8853\u6709\u9650\u516c\u53f8<\/a>-\u4e2d\u56fd\u306b\u304a\u3051\u308b\u6700\u9ad8\u306e\u8a8d\u5b9a\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"top-global-certified-medical-swab-manufacturers\">\u4e16\u754c\u306e\u8a8d\u8a3c\u533b\u7642\u7528\u7dbf\u68d2\u30c8\u30c3\u30d7\u30e1\u30fc\u30ab\u30fc<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u30e1\u30fc\u30ab\u30fc<\/th><th>\u56fd\u540d<\/th><th>\u4e3b\u8981\u8a8d\u5b9a\u8cc7\u683c<\/th><th>\u7279\u7b46\u3059\u3079\u304d\u5f37\u307f<\/th><\/tr><\/thead><tbody><tr><td><strong>\u6c5f\u8607\u6f22\u6052\u533b\u7642\u6280\u8853\u6709\u9650\u516c\u53f8<\/strong><\/td><td>\u4e2d\u56fd<\/td><td>ISO13485\u3001ISO9001\u3001CE\u3001FDA\u3001NPA<\/td><td>\u30d5\u30eb\u30ec\u30f3\u30b8\u306e\u6d88\u8017\u54c1\u3001\u5e83\u3044\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u3001\u5f37\u529b\u306a\u7814\u7a76\u958b\u767a<\/td><\/tr><tr><td>\u30d4\u30e5\u30fc\u30ea\u30bf\u30f3 \u30e1\u30c7\u30a3\u30ab\u30eb \u30d7\u30ed\u30c0\u30af\u30c4<\/td><td>\u30a2\u30e1\u30ea\u30ab<\/td><td>ISO13485\u3001FDA\u3001CE<\/td><td>\u9ad8\u54c1\u8cea\u306e\u30d5\u30ed\u30c3\u30af\u52a0\u5de5\u7dbf\u68d2\u3001\u5f37\u529b\u306a\u7c73\u56fd\u6d41\u901a<\/td><\/tr><tr><td>\u30b3\u30d1\u30f3\u30fb\u30c0\u30a4\u30a2\u30b0\u30ce\u30b9\u30c6\u30a3\u30c3\u30af\u30b9<\/td><td>\u30a4\u30bf\u30ea\u30a2<\/td><td>ISO13485\u3001CE<\/td><td>\u7fa4\u308c\u7dbf\u68d2\u6280\u8853\u306e\u30d1\u30a4\u30aa\u30cb\u30a2\u3001\u30b0\u30ed\u30fc\u30d0\u30eb\u306b\u5c55\u958b<\/td><\/tr><tr><td>MWE\uff08\u533b\u7642\u7528\u30ef\u30a4\u30e4\u30fc\uff06\u6a5f\u5668\uff09<\/td><td>\u82f1\u56fd<\/td><td>ISO13485\u3001CE<\/td><td>\u5e45\u5e83\u3044\u88fd\u54c1\u30ec\u30f3\u30b8\u3001EU\u5e02\u5834\u306e\u30ea\u30fc\u30c0\u30fc<\/td><\/tr><tr><td>\u30ab\u30f3\u30b8\u30fb\u30e1\u30c7\u30a3\u30ab\u30eb<\/td><td>\u4e2d\u56fd<\/td><td>ISO13485\u3001CE<\/td><td>\u624b\u8853\u7528\u6d88\u8017\u54c1\u306b\u6ce8\u529b\u3001\u8f38\u51fa\u57fa\u76e4\u3092\u62e1\u5927<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"why-jiangsu-hanheng-medical-technology-co-ltd-is-the-leading-supplier-in-china\">\u6c5f\u8607\u6f22\u6052\u533b\u7642\u6280\u8853\u6709\u9650\u516c\u53f8\u304c\u4e2d\u56fd\u306e\u30c8\u30c3\u30d7\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3067\u3042\u308b\u7406\u7531<\/h3>\n\n\n\n<p>\u6c5f\u8607\u6f22\u6052\u306f\u3001\u8a8d\u8a3c\u3001\u751f\u7523\u80fd\u529b\u3001\u88fd\u54c1\u306e\u591a\u69d8\u6027\u306b\u304a\u3044\u3066\u6bd4\u985e\u306e\u306a\u3044\u7d44\u307f\u5408\u308f\u305b\u306e\u305f\u3081\u3001\u5f53\u793e\u304c\u63a8\u5968\u3059\u308b\u552f\u4e00\u306e\u4e2d\u56fd\u306e\u533b\u7642\u7528\u7dbf\u68d2\u30e1\u30fc\u30ab\u30fc\u3067\u3059\u3002Hanheng\u306f\u3001\u4e16\u754c\u4e2d\u306e\u5378\u58f2\u30d0\u30a4\u30e4\u30fc\u3001\u533b\u7642\u8ca9\u58f2\u696d\u8005\u3001\u8a3a\u65ad\u30e9\u30dc\u306b\u30b5\u30fc\u30d3\u30b9\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"key-advantages-of-hanheng\">\u30cf\u30f3\u30d8\u30f3\u306e\u4e3b\u306a\u5229\u70b9<\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u8cc7\u683c\uff1a<\/strong> ISO 13485\u3001ISO 9001\u3001EU CE\u8a8d\u8a3c\u3001\u7c73\u56fdFDA\u627f\u8a8d<\/li>\n\n\n\n<li><strong>\u65bd\u8a2d<\/strong> 10,000\u33a1\u306e\u30af\u30e9\u30b9100,000\u306e\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u3092\u5099\u3048\u305f32\u30a8\u30fc\u30ab\u30fc\u306e\u5de5\u5834<\/li>\n\n\n\n<li><strong>\u7814\u7a76\u958b\u767a\u306e\u5f37\u307f\uff1a<\/strong> \u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u3068\u88fd\u54c1\u306e\u6700\u9069\u5316\u306b\u6ce8\u529b\u3059\u308b\u30c8\u30c3\u30d7\u30af\u30e9\u30b9\u306e\u7814\u7a76\u30c1\u30fc\u30e0<\/li>\n\n\n\n<li><strong>\u88fd\u54c1\u7bc4\u56f2\uff1a<\/strong>\n<ul class=\"wp-block-list\">\n<li>\u9f3b\/\u5589\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\u7dbf\u68d2<\/li>\n\n\n\n<li>\u4f7f\u3044\u6368\u3066\u5b50\u5bae\u9838\u90e8\u30b5\u30f3\u30d7\u30eb\u30b3\u30ec\u30af\u30bf\u30fc<\/li>\n\n\n\n<li>\u6ec5\u83cc\u6e08\u307f\u5b50\u5bae\u9838\u90e8\u30d6\u30e9\u30b7<\/li>\n\n\n\n<li>\u5a66\u4eba\u79d1\u7528\u30b9\u30af\u30ec\u30fc\u30d1\u30fc<\/li>\n\n\n\n<li>\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\u30dc\u30c3\u30af\u30b9\u3068\u5a66\u4eba\u79d1\u691c\u67fb\u30ad\u30c3\u30c8<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"why-b2b-buyers-trust-hanheng\">B2B\u30d0\u30a4\u30e4\u30fc\u304c\u30cf\u30f3\u30d8\u30f3\u3092\u4fe1\u983c\u3059\u308b\u7406\u7531\uff1a<\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u30b0\u30ed\u30fc\u30d0\u30eb\u30fb\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9<\/strong> \u30b7\u30fc\u30e0\u30ec\u30b9\u306a\u5e02\u5834\u53c2\u5165\u306e\u305f\u3081\u306e\u6b27\u7c73\u306e\u898f\u5236\u8981\u4ef6\u306b\u9069\u5408<\/li>\n\n\n\n<li><strong>\u5b89\u5b9a\u4f9b\u7d66\uff1a<\/strong> \u5927\u898f\u6a21\u751f\u7523\u306b\u3088\u308a\u3001\u9700\u8981\u6025\u5897\u6642\u306b\u3082\u4fe1\u983c\u6027\u3092\u78ba\u4fdd<\/li>\n\n\n\n<li><strong>\u30ab\u30b9\u30bf\u30e0\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\uff1a<\/strong> \u30d7\u30e9\u30a4\u30d9\u30fc\u30c8\u30fb\u30e9\u30d9\u30ea\u30f3\u30b0\u3084\u4ed5\u69d8\u9069\u5408\u306e\u305f\u3081\u306eOEM\/ODM\u30b5\u30fc\u30d3\u30b9\u3092\u63d0\u4f9b\u3002<\/li>\n\n\n\n<li><strong>\u6ec5\u83cc\u4fdd\u8a3c\uff1a<\/strong> \u3059\u3079\u3066\u306e\u7dbf\u68d2\u306f\u6ec5\u83cc\u3055\u308c\u3001\u533b\u7642\u57fa\u6e96\u306b\u5f93\u3063\u3066\u500b\u5225\u306b\u5305\u88c5\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/li>\n<\/ul>\n\n\n\n<p>\ud83d\udc49 <strong>\u30cf\u30f3\u30d8\u30f3\u3068\u3064\u306a\u304c\u308b<\/strong><br>\ud83c\udf10 \u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\uff1a <a href=\"https:\/\/hanheng-medical.com\/ja\/\" target=\"_blank\" rel=\"noreferrer noopener\">www.hanheng-medical.com<\/a><br>\ud83d\udce7 E\u30e1\u30fc\u30eb\uff1a <a href=\"mailto:sales@hanhengmed.com\" target=\"_blank\" rel=\"noreferrer noopener\">sales@hanhengmed.com<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"pro-tips-for-b2b-buyers-when-choosing-a-certified-manufacturer\">B2B\u30d0\u30a4\u30e4\u30fc\u304c\u8a8d\u8a3c\u30e1\u30fc\u30ab\u30fc\u3092\u9078\u3076\u969b\u306e\u30d7\u30ed\u306e\u30d2\u30f3\u30c8<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u66f8\u985e\u306e\u63d0\u51fa\u3092\u6c42\u3081\u308b\uff1a<\/strong> ISO 13485\u3001FDA\u3001CE\u8a3c\u660e\u66f8\u306e\u30b3\u30d4\u30fc\u3092\u5e38\u306b\u6c42\u3081\u308b\u3002<\/li>\n\n\n\n<li><strong>\u65bd\u8a2d\u3092\u8a2a\u554f\u3059\u308b\uff08\u53ef\u80fd\u306a\u5834\u5408\uff09\uff1a<\/strong> \u751f\u7523\u73fe\u5834\u3092\u76e3\u67fb\u3059\u308b\u3053\u3068\u3067\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u691c\u8a3c\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002<\/li>\n\n\n\n<li><strong>\u30d0\u30c3\u30c1\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u306b\u3064\u3044\u3066\u5c0b\u306d\u308b\uff1a<\/strong> \u88fd\u54c1\u30ea\u30b3\u30fc\u30eb\u3084\u54c1\u8cea\u4fdd\u8a3c\u306b\u4e0d\u53ef\u6b20\u3002<\/li>\n\n\n\n<li><strong>\u7814\u7a76\u958b\u767a\u80fd\u529b\u3092\u8a55\u4fa1\u3059\u308b\uff1a<\/strong> \u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u306f\u88fd\u54c1\u306e\u6027\u80fd\u5411\u4e0a\u3068\u5dee\u5225\u5316\u306b\u3064\u306a\u304c\u308b\u3002<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<figure class=\"wp-block-gallery has-nested-images columns-default is-cropped wp-block-gallery-2 is-layout-flex wp-block-gallery-is-layout-flex\">\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"800\" data-id=\"2984\" src=\"\u7d30\u80de\u8a3a\u30d6\u30e9\u30b7\u88fd\u9020\uff1a\u81ea\u52d5\u5316\u3068\u54c1\u8cea\u30c8\u30ec\u30f3\u30c92025 - Hanheng Medical\" alt=\"\" class=\"wp-image-2984\" title=\"\" srcset=\"\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" data-srcset=\"\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"800\" data-id=\"2976\" src=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Nylon-Flocked-Endocervical-Swab-HPV-DNA-tests-for-cervical-cancer-screening-A-07-2.jpg\" alt=\"\" class=\"wp-image-2976\" title=\"\" srcset=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Nylon-Flocked-Endocervical-Swab-HPV-DNA-tests-for-cervical-cancer-screening-A-07-2.jpg 800w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Nylon-Flocked-Endocervical-Swab-HPV-DNA-tests-for-cervical-cancer-screening-A-07-2-300x300.jpg 300w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Nylon-Flocked-Endocervical-Swab-HPV-DNA-tests-for-cervical-cancer-screening-A-07-2-150x150.jpg 150w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Nylon-Flocked-Endocervical-Swab-HPV-DNA-tests-for-cervical-cancer-screening-A-07-2-768x768.jpg 768w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"800\" data-id=\"2977\" src=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Nylon-Flocked-Endocervical-Swab-HPV-DNA-tests-for-cervical-cancer-screening-A-07-3.jpg\" alt=\"\" class=\"wp-image-2977\" title=\"\" srcset=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Nylon-Flocked-Endocervical-Swab-HPV-DNA-tests-for-cervical-cancer-screening-A-07-3.jpg 800w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Nylon-Flocked-Endocervical-Swab-HPV-DNA-tests-for-cervical-cancer-screening-A-07-3-300x300.jpg 300w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Nylon-Flocked-Endocervical-Swab-HPV-DNA-tests-for-cervical-cancer-screening-A-07-3-150x150.jpg 150w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Nylon-Flocked-Endocervical-Swab-HPV-DNA-tests-for-cervical-cancer-screening-A-07-3-768x768.jpg 768w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><\/figure>\n<\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"8-how-to-verify-a-medical-swab-manufacturer-s-certifications-and-compliance\">8.\u533b\u7642\u7528\u7dbf\u68d2\u30e1\u30fc\u30ab\u30fc\u306e\u8a8d\u8a3c\u3068\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u78ba\u8a8d\u3059\u308b\u65b9\u6cd5<\/h2>\n\n\n\n<p>\u30e1\u30fc\u30ab\u30fc\u304c\u8a8d\u8a3c\u3092\u53d6\u5f97\u3057\u3066\u3044\u308b\u3068\u4e3b\u5f35\u3059\u308b\u5834\u5408\u3067\u3082\u3001B2B\u30d0\u30a4\u30e4\u30fc\u306f\u30c7\u30e5\u30fc\u30c7\u30ea\u30b8\u30a7\u30f3\u30b9\u3092\u5b9f\u65bd\u3057\u3001\u8a8d\u8a3c\u306e\u6b63\u5f53\u6027\u3068\u6709\u52b9\u6027\u3092\u78ba\u8a8d\u3059\u3079\u304d\u3067\u3042\u308b\u3002\u865a\u507d\u306e\u8aac\u660e\u3084\u53e4\u3044\u8a8d\u8a3c\u306f\u3001\u7279\u306b\u898f\u5236\u5e02\u5834\u306b\u8f38\u5165\u3059\u308b\u5834\u5408\u3001\u6cd5\u7684\u30ea\u30b9\u30af\u3084\u5065\u5eb7\u30ea\u30b9\u30af\u306b\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"step-by-step-guide-to-verifying-manufacturer-certifications\">\u30e1\u30fc\u30ab\u30fc\u8a8d\u8a3c\u306e\u78ba\u8a8d\u30b9\u30c6\u30c3\u30d7\u30fb\u30d0\u30a4\u30fb\u30b9\u30c6\u30c3\u30d7\u30fb\u30ac\u30a4\u30c9<\/h3>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"1-request-official-certificates\">1. <strong>\u516c\u7684\u8a3c\u660e\u66f8\u306e\u30ea\u30af\u30a8\u30b9\u30c8<\/strong><\/h4>\n\n\n\n<p>\u30e1\u30fc\u30ab\u30fc\u306b\u4ee5\u4e0b\u306e\u30c7\u30b8\u30bf\u30eb\u30b3\u30d4\u30fc\uff08PDF\uff09\u3092\u63d0\u4f9b\u3057\u3066\u3082\u3089\u3046\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>ISO 13485\u304a\u3088\u3073ISO 9001\u8a8d\u8a3c<\/li>\n\n\n\n<li>CE\u9069\u5408\u5ba3\u8a00\u304a\u3088\u3073\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30fb\u30dc\u30c7\u30a3\u756a\u53f7<\/li>\n\n\n\n<li>FDA 510(k)\u30ec\u30bf\u30fc\u307e\u305f\u306f\u767b\u9332\u756a\u53f7<\/li>\n\n\n\n<li>GMP\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u5831\u544a\u66f8\uff08\u3042\u308b\u5834\u5408\uff09<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"2-check-validity-dates-and-scope\">2. <strong>\u6709\u52b9\u671f\u9650\u3068\u7bc4\u56f2\u3092\u78ba\u8a8d\u3059\u308b<\/strong><\/h4>\n\n\n\n<p>\u305d\u308c\u3092\u78ba\u8a8d\u3059\u308b\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u8a8d\u8a3c\u304c\u6709\u52b9\u3067\u3042\u308b\u3053\u3068\uff08\u6709\u52b9\u671f\u9650\u304c\u5207\u308c\u3066\u3044\u306a\u3044\u3053\u3068\uff09<\/li>\n\n\n\n<li>\u8a8d\u8a3c\u7bc4\u56f2\u306b\u306f\u3001\u300c\u533b\u7642\u7528\u7dbf\u68d2\u300d\u307e\u305f\u306f\u95a2\u9023\u6d88\u8017\u54c1\u304c\u542b\u307e\u308c\u308b\u3002<\/li>\n\n\n\n<li>\u767a\u884c\u6a5f\u95a2\u304c\u8a8d\u5b9a\u3092\u53d7\u3051\u3066\u3044\u308b\uff08\u30c6\u30e5\u30d5\u30ba\u30fc\u30c9\u3001SGS\u3001BSI\u3001DQS \u306a\u3069\uff09\u3002<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"3-cross-check-with-regulatory-databases\">3. <strong>\u898f\u5236\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3068\u306e\u30af\u30ed\u30b9\u30c1\u30a7\u30c3\u30af<\/strong><\/h4>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u8a8d\u8a3c<\/th><th>\u3069\u3053\u3067\u78ba\u8a8d\u3059\u308b\u304b<\/th><\/tr><\/thead><tbody><tr><td><strong>\u98df\u54c1\u533b\u85ac\u54c1\u5c40<\/strong><\/td><td><a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfRL\/rl.cfm\" target=\"_blank\" rel=\"noreferrer noopener\">FDA\u8a2d\u7acb\u767b\u9332\u3068\u6a5f\u5668\u30ea\u30b9\u30c8<\/a><\/td><\/tr><tr><td><strong>CE\u30de\u30fc\u30ad\u30f3\u30b0<\/strong><\/td><td>\u8a3c\u660e\u66f8\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30fb\u30dc\u30c7\u30a3\u306b\u78ba\u8a8d\u3059\u308b\u3002<\/td><\/tr><tr><td><strong>ISO 13485<\/strong><\/td><td>\u8a8d\u8a3c\u6a5f\u95a2\u306b\u554f\u3044\u5408\u308f\u305b\u308b\u304b\u3001IAF\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3092\u30c1\u30a7\u30c3\u30af\u3059\u308b\u3002<\/td><\/tr><tr><td><strong>NMPA\uff08\u4e2d\u56fd\uff09<\/strong><\/td><td><a href=\"https:\/\/www.nmpa.gov.cn\/\" target=\"_blank\" rel=\"noreferrer noopener\">NMPA\u516c\u5f0f\u30b5\u30a4\u30c8\uff08\u4e2d\u56fd\u8a9e\uff09<\/a><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"4-request-a-virtual-or-on-site-audit\">4. <strong>\u4eee\u60f3\u76e3\u67fb\u307e\u305f\u306f\u73fe\u5730\u76e3\u67fb\u306e\u4f9d\u983c<\/strong><\/h4>\n\n\n\n<p>\u7279\u306b\u5927\u898f\u6a21\u8abf\u9054\u306e\u5834\u5408\u306f\u3001\u30d3\u30c7\u30aa\u30c4\u30a2\u30fc\u306b\u3088\u308b\u30d0\u30fc\u30c1\u30e3\u30eb\u76e3\u67fb\u3092\u5b9f\u65bd\u3059\u308b\u304b\u3001\u5de5\u5834\u3078\u306e\u76f4\u63a5\u8a2a\u554f\u3092\u624b\u914d\u3059\u308b\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u4ee5\u4e0b\u306b\u3064\u3044\u3066\u306e\u6d1e\u5bdf\u304c\u5f97\u3089\u308c\u308b\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u6761\u4ef6<\/li>\n\n\n\n<li>\u6ec5\u83cc\u30d7\u30ed\u30bb\u30b9<\/li>\n\n\n\n<li>\u54c1\u8cea\u7ba1\u7406\u7814\u7a76\u6240<\/li>\n\n\n\n<li>\u30d1\u30c3\u30b1\u30fc\u30b8\u30f3\u30b0\u3068\u30e9\u30d9\u30ea\u30f3\u30b0\u624b\u9806<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"5-ask-for-testing-reports\">5. <strong>\u691c\u67fb\u5831\u544a\u66f8\u3092\u6c42\u3081\u308b<\/strong><\/h4>\n\n\n\n<p>\u4fe1\u983c\u3067\u304d\u308b\u30e1\u30fc\u30ab\u30fc\u3067\u3042\u308c\u3070\u3001\u305d\u306e\u3088\u3046\u306a\u30b5\u30fc\u30d3\u30b9\u3082\u63d0\u4f9b\u3057\u3066\u304f\u308c\u308b\u3060\u308d\u3046\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u7121\u83cc\u8a66\u9a13\u5831\u544a\u66f8<\/li>\n\n\n\n<li>\u751f\u4f53\u9069\u5408\u6027\u8a66\u9a13\u7d50\u679c\uff08ISO 10993\uff09<\/li>\n\n\n\n<li>\u6a5f\u68b0\u7684\u6027\u80fd\u30c7\u30fc\u30bf\uff08\u5148\u7aef\u5f37\u5ea6\u3001\u5438\u53ce\u6027\uff09<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"red-flags-to-watch-for\">\u6ce8\u610f\u3059\u3079\u304d\u30ec\u30c3\u30c9\u30d5\u30e9\u30c3\u30b0<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u66d6\u6627\u307e\u305f\u306f\u4e0d\u660e\u78ba\u306a\u8a8d\u8a3c\u6587\u66f8<\/li>\n\n\n\n<li>\u6709\u52b9\u671f\u9650\u307e\u305f\u306f\u6709\u52b9\u7bc4\u56f2\u306e\u306a\u3044\u8a3c\u660e\u66f8<\/li>\n\n\n\n<li>\u4e0d\u660e\u307e\u305f\u306f\u672a\u8a8d\u8a3c\u306e\u767a\u884c\u6a5f\u95a2<\/li>\n\n\n\n<li>\u66f8\u985e\u306e\u63d0\u51fa\u3084\u76e3\u67fb\u306e\u62d2\u5426<\/li>\n<\/ul>\n\n\n\n<p>\u6c5f\u8607\u6f22\u6052\u306e\u3088\u3046\u306a\u8a8d\u8a3c\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3092\u9078\u3079\u3070\u3001\u7a4d\u6975\u7684\u306b\u6587\u66f8\u3092\u5171\u6709\u3057\u3001\u5de5\u5834\u898b\u5b66\u3092\u63d0\u4f9b\u3057\u3001\u898f\u5236\u5f53\u5c40\u3078\u306e\u63d0\u51fa\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u305f\u3081\u3001\u3053\u3046\u3057\u305f\u30ea\u30b9\u30af\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"9-faqs-common-questions-about-medical-swab-certifications-for-b2b-buyers\">9.\u3088\u304f\u3042\u308b\u8cea\u554fB2B\u30d0\u30a4\u30e4\u30fc\u306e\u305f\u3081\u306e\u533b\u7642\u7528\u7dbf\u68d2\u8a8d\u8a3c\u306b\u95a2\u3059\u308b\u3088\u304f\u3042\u308b\u8cea\u554f<\/h2>\n\n\n\n<p><strong>Q1\uff1aISO9001\u3068ISO13485\u306f\u540c\u3058\u3067\u3059\u304b\uff1f<\/strong><br>ISO9001\u306f\u4e00\u822c\u7684\u306a\u54c1\u8cea\u7ba1\u7406\u898f\u683c\u3067\u3042\u308a\u3001ISO13485\u306f\u30b9\u30ef\u30d6\u88fd\u9020\u696d\u8005\u3092\u542b\u3080\u533b\u7642\u6a5f\u5668\u88fd\u9020\u696d\u8005\u306b\u7279\u5316\u3057\u305f\u898f\u683c\u3067\u3042\u308b\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p><strong>Q2: \u30b9\u30ef\u30d6\u3092\u81ea\u56fd\u306b\u8f38\u5165\u3059\u308b\u969b\u3001FDA\u3084CE\u8a8d\u8a3c\u306f\u5fc5\u8981\u3067\u3059\u304b\uff1f<\/strong><br>\u3042\u306a\u305f\u306e\u56fd\u306e\u898f\u5236\u306b\u3088\u308a\u307e\u3059\u3002\u7c73\u56fd\u3067\u306f\u3001\u307b\u3068\u3093\u3069\u306e\u8a3a\u65ad\u7528\u7dbf\u68d2\u306bFDA 510(k)\u304c\u5fc5\u8981\u3067\u3059\u3002EU\u3067\u306fCE\u30de\u30fc\u30ad\u30f3\u30b0\u304c\u5fc5\u9808\u3067\u3059\u3002\u305d\u306e\u4ed6\u306e\u591a\u304f\u306e\u56fd\u3067\u306f\u3001\u3069\u3061\u3089\u304b\u3001\u307e\u305f\u306f\u4e21\u65b9\u306e\u8a8d\u8a3c\u304c\u8a8d\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p><strong>Q3: \u4e2d\u56fd\u306e\u7dbf\u68d2\u30e1\u30fc\u30ab\u30fc\u306f\u4fe1\u7528\u3067\u304d\u307e\u3059\u304b\uff1f<\/strong><br>\u9069\u5207\u306a\u8a8d\u8a3c\u3092\u53d7\u3051\u3066\u3044\u308c\u3070\u3002\u4f8b\u3048\u3070\u3001Jiangsu Hanheng Medical\u793e\u306f\u3001ISO 13485\u3001FDA\u3001\u304a\u3088\u3073CE\u8a8d\u8a3c\u3092\u53d6\u5f97\u3057\u3066\u304a\u308a\u3001\u30d8\u30eb\u30b9\u30b1\u30a2\u30c7\u30a3\u30b9\u30c8\u30ea\u30d3\u30e5\u30fc\u30bf\u30fc\u304b\u3089\u4e16\u754c\u7684\u306b\u4fe1\u983c\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p><strong>Q4: \u30af\u30e9\u30b9 I \u3068\u30af\u30e9\u30b9 II \u306e\u7dbf\u68d2\u306e\u9055\u3044\u306f\u4f55\u3067\u3059\u304b\uff1f<\/strong><br>\u30af\u30e9\u30b9I\u306e\u30b9\u30ef\u30d6\u306f\u6c4e\u7528\u3067\u3042\u308b\u304c\u3001\u30af\u30e9\u30b9II\u306e\u30b9\u30ef\u30d6\uff08\u9f3b\u54bd\u982d\u30b9\u30ef\u30d6\u306a\u3069\uff09\u306f\u8a3a\u65ad\u7528\u3067\u3042\u308a\u3001\u3088\u308a\u53b3\u683c\u306a\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3068\u898f\u5236\u5f53\u5c40\u306e\u627f\u8a8d\u304c\u5fc5\u8981\u3067\u3042\u308b\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p><strong>Q5\uff1a\u30e1\u30fc\u30ab\u30fc\u306f\u3069\u308c\u304f\u3089\u3044\u306e\u983b\u5ea6\u3067\u8a8d\u8a3c\u3092\u66f4\u65b0\u3059\u3079\u304d\u3067\u3059\u304b\uff1f<\/strong><br>\u901a\u5e38\u3001ISO\u3068CE\u8a8d\u8a3c\u306f3\u5e74\u3054\u3068\u306b\u66f4\u65b0\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u3001\u6bce\u5e74\u30b5\u30fc\u30d9\u30a4\u30e9\u30f3\u30b9\u76e3\u67fb\u304c\u884c\u308f\u308c\u308b\u3002FDA\u767b\u9332\u306f\u6bce\u5e74\u66f4\u65b0\u304c\u5fc5\u8981\u3067\u3059\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p><strong>Q6: \u8a8d\u5b9a\u30e1\u30fc\u30ab\u30fc\u306bOEM\/\u30d7\u30e9\u30a4\u30d9\u30fc\u30c8\u30fb\u30e9\u30d9\u30eb\u3092\u4f9d\u983c\u3067\u304d\u307e\u3059\u304b\uff1f<\/strong><br>\u306f\u3044\u3002Hanheng\u306e\u3088\u3046\u306a\u8a8d\u5b9a\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u8a8d\u8a3c\u57fa\u6e96\u306b\u6e96\u62e0\u3057\u306a\u304c\u3089\u3001OEM\u304a\u3088\u3073ODM\u30b5\u30fc\u30d3\u30b9\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p><strong>Q7: \u672a\u8a8d\u8a3c\u306e\u30b9\u30ef\u30d6\u3092\u8f38\u5165\u3057\u305f\u5834\u5408\u306f\u3069\u3046\u306a\u308a\u307e\u3059\u304b\uff1f<\/strong><br>\u901a\u95a2\u306e\u9045\u308c\u3001\u88fd\u54c1\u306e\u62bc\u53ce\u3001\u6cd5\u7684\u7f70\u5247\u3001\u88fd\u54c1\u306e\u4e0d\u5177\u5408\u3084\u6c5a\u67d3\u306e\u5834\u5408\u306e\u8cac\u4efb\u554f\u984c\u306b\u76f4\u9762\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p><strong>Q8: \u4e2d\u56fd\u306e\u4fe1\u983c\u3067\u304d\u308b\u8a8d\u8a3c\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3068\u9023\u7d61\u3092\u53d6\u308b\u306b\u306f\u3069\u3046\u3059\u308c\u3070\u3088\u3044\u3067\u3059\u304b\uff1f<\/strong><br>\u6c5f\u8607\u6f22\u6052\u533b\u7642\u6280\u8853\u6709\u9650\u516c\u53f8\u306e\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\u304b\u3089\u304a\u554f\u3044\u5408\u308f\u305b\u3044\u305f\u3060\u3051\u307e\u3059\uff1a <a href=\"https:\/\/hanheng-medical.com\/ja\/\" target=\"_blank\" rel=\"noreferrer noopener\">www.hanheng-medical.com<\/a> \u307e\u305f\u306fE\u30e1\u30fc\u30eb\uff1a <a href=\"mailto:sales@hanhengmed.com\" target=\"_blank\" rel=\"noreferrer noopener\">sales@hanhengmed.com<\/a>.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p><strong>\u7d50\u8ad6\u3068\u884c\u52d5\u3078\u306e\u547c\u3073\u304b\u3051<\/strong><\/p>\n\n\n\n<p>\u533b\u7642\u6a5f\u95a2\u3001\u691c\u67fb\u5ba4\u3001\u6d41\u901a\u696d\u8005\u306b\u3068\u3063\u3066\u3001\u533b\u7642\u7528\u7dbf\u68d2\u306e\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304c\u5b8c\u5168\u306b\u8a8d\u8a3c\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u306f\u3001\u5358\u306a\u308b\u30d9\u30b9\u30c8\u30d7\u30e9\u30af\u30c6\u30a3\u30b9\u3067\u306f\u306a\u304f\u3001\u898f\u5236\u4e0a\u5fc5\u8981\u306a\u3053\u3068\u3067\u3059\u3002ISO13485\u3001FDA\u3001CE\u306a\u3069\u306e\u8a8d\u8a3c\u306f\u3001\u88fd\u54c1\u306e\u54c1\u8cea\u3092\u8a3c\u660e\u3059\u308b\u3060\u3051\u3067\u306a\u304f\u3001\u30ea\u30b9\u30af\u3092\u8efd\u6e1b\u3057\u3001\u8a3a\u65ad\u7cbe\u5ea6\u3092\u5411\u4e0a\u3055\u305b\u3001\u56fd\u5883\u3092\u8d8a\u3048\u305f\u7269\u6d41\u3092\u5408\u7406\u5316\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p><a href=\"https:\/\/hanheng-medical.com\/ja\/contact-us\/\">\u6c5f\u8607\u6f22\u6052\u533b\u7642\u6280\u8853\u6709\u9650\u516c\u53f8 <\/a>Hanheng\u306f\u3001\u5305\u62ec\u7684\u306a\u88fd\u54c1\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa\u3068\u5b8c\u5168\u306a\u898f\u5236\u9075\u5b88\u3092\u5099\u3048\u305f\u3001\u5b8c\u5168\u306b\u8a8d\u5b9a\u3055\u308c\u305f\u4e16\u754c\u7684\u306b\u8a8d\u3081\u3089\u308c\u305f\u30e1\u30fc\u30ab\u30fc\u3068\u3057\u3066\u969b\u7acb\u3063\u3066\u3044\u307e\u3059\u3002\u4e0a\u54bd\u982d\u30b9\u30ef\u30d6\u3001\u5b50\u5bae\u9838\u90e8\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\u30d6\u30e9\u30b7\u3001\u8a3a\u65ad\u30ad\u30c3\u30c8\u306a\u3069\u3001Hanheng\u306f\u4e2d\u56fd\u306b\u304a\u3051\u308b\u304a\u5ba2\u69d8\u306e\u7406\u60f3\u7684\u306a\u30d1\u30fc\u30c8\u30ca\u30fc\u3067\u3059\u3002<\/p>\n\n\n\n<p>\ud83d\udccc <strong>\u533b\u7642\u7528\u7dbf\u68d2\u306e\u3054\u6ce8\u6587\u306f\u3044\u304b\u304c\u3067\u3059\u304b\uff1f<\/strong><br>\u30ab\u30b9\u30bf\u30e0\u898b\u7a4d\u3082\u308a\u3084\u898f\u5236\u306b\u95a2\u3059\u308b\u3054\u76f8\u8ac7\u306f\u3001Hanheng\u306e\u5c02\u9580\u55b6\u696d\u30c1\u30fc\u30e0\u306b\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\uff1a<br>\ud83d\udce7 <a href=\"mailto:sales@hanhengmed.com\" target=\"_blank\" rel=\"noreferrer noopener\">sales@hanhengmed.com<\/a><br>\ud83c\udf10 <a href=\"https:\/\/hanheng-medical.com\/ja\/\" target=\"_blank\" rel=\"noreferrer noopener\">www.hanheng-medical.com<\/a><\/p>\n\n\n\n<p>\u8a8d\u8a3c\u3055\u308c\u305f\u54c1\u8cea\u3067\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u3092\u4fdd\u8b77\u3057\u307e\u3059\u3002\u30d1\u30fc\u30c8\u30ca\u30fc <a href=\"https:\/\/hanheng-medical.com\/ja\/\">\u6f22\u6052<\/a>.<\/p>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>1.\u306f\u3058\u3081\u306b\u533b\u7642\u7528\u7dbf\u68d2\u88fd\u9020\u306b\u304a\u3051\u308b\u8a8d\u8a3c\u306e\u91cd\u8981\u6027 \u898f\u5236\u306e\u53b3\u3057\u3044\u533b\u7642\u696d\u754c\u3067\u306f\u3001\u54c1\u8cea\u3001\u5b89\u5168\u6027\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306f\u8b72\u308c\u307e\u305b\u3093\u3002\u75c5\u9662\u306e\u8abf\u9054\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u3001\u8a3a\u65ad\u30e9\u30dc\u306e\u30b9\u30da\u30b7\u30e3\u30ea\u30b9\u30c8\u3001\u533b\u7642\u7528\u7dbf\u68d2\u306e\u5378\u58f2\u3092\u304a\u8003\u3048\u306e\u30c7\u30a3\u30b9\u30c8\u30ea\u30d3\u30e5\u30fc\u30bf\u30fc\u306a\u3069\u3001\u3069\u306e\u3088\u3046\u306a\u7acb\u5834\u306e\u65b9\u3067\u3042\u3063\u3066\u3082\u3001\u533b\u7642\u7528\u7dbf\u68d2\u306e\u88fd\u9020\u306b\u304a\u3051\u308b\u8a8d\u8a3c\u306e\u9078\u629e\u306f\u91cd\u8981\u3067\u3059\u3002<\/p>","protected":false},"author":3,"featured_media":2932,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_gspb_post_css":"","_kad_blocks_custom_css":"","_kad_blocks_head_custom_js":"","_kad_blocks_body_custom_js":"","_kad_blocks_footer_custom_js":"","_kad_post_transparent":"","_kad_post_title":"","_kad_post_layout":"","_kad_post_sidebar_id":"","_kad_post_content_style":"","_kad_post_vertical_padding":"","_kad_post_feature":"","_kad_post_feature_position":"","_kad_post_header":false,"_kad_post_footer":false,"_kad_post_classname":"","footnotes":""},"categories":[1],"tags":[],"class_list":["post-3143","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"acf":[],"taxonomy_info":{"category":[{"value":1,"label":"Uncategorized"}]},"featured_image_src_large":["https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-Cleaning-G-014-1.jpg",800,800,false],"author_info":{"display_name":"yiyunyinglucky","author_link":"https:\/\/hanheng-medical.com\/ja\/author\/yiyunyinglucky\/"},"comment_info":0,"category_info":[{"term_id":1,"name":"Uncategorized","slug":"uncategorized","term_group":0,"term_taxonomy_id":1,"taxonomy":"category","description":"","parent":0,"count":149,"filter":"raw","cat_ID":1,"category_count":149,"category_description":"","cat_name":"Uncategorized","category_nicename":"uncategorized","category_parent":0}],"tag_info":false,"_links":{"self":[{"href":"https:\/\/hanheng-medical.com\/ja\/wp-json\/wp\/v2\/posts\/3143","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/hanheng-medical.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/hanheng-medical.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/hanheng-medical.com\/ja\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/hanheng-medical.com\/ja\/wp-json\/wp\/v2\/comments?post=3143"}],"version-history":[{"count":1,"href":"https:\/\/hanheng-medical.com\/ja\/wp-json\/wp\/v2\/posts\/3143\/revisions"}],"predecessor-version":[{"id":3144,"href":"https:\/\/hanheng-medical.com\/ja\/wp-json\/wp\/v2\/posts\/3143\/revisions\/3144"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/hanheng-medical.com\/ja\/wp-json\/wp\/v2\/media\/2932"}],"wp:attachment":[{"href":"https:\/\/hanheng-medical.com\/ja\/wp-json\/wp\/v2\/media?parent=3143"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/hanheng-medical.com\/ja\/wp-json\/wp\/v2\/categories?post=3143"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/hanheng-medical.com\/ja\/wp-json\/wp\/v2\/tags?post=3143"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}