{"id":9268,"date":"2025-11-26T17:41:51","date_gmt":"2025-11-26T09:41:51","guid":{"rendered":"https:\/\/regask.com\/?p=9268"},"modified":"2025-12-02T20:09:25","modified_gmt":"2025-12-02T12:09:25","slug":"hsa%e3%82%b7%e3%83%b3%e3%82%ac%e3%83%9d%e3%83%bc%e3%83%ab%e3%81%af%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8%e3%81%ae%e3%82%b3%e3%83%b3%e3%83%97%e3%83%a9%e3%82%a4%e3%82%a2%e3%83%b3%e3%82%b9%e3%82%b0","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/hsa-singapore-issues-updated-guidance-on-medical-device-compliance-grouping-and-submission-requirements\/","title":{"rendered":"HSA\u30b7\u30f3\u30ac\u30dd\u30fc\u30eb\u3001\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b\u6700\u65b0\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u767a\u884c\u2026"},"content":{"rendered":"<p>2025\u5e7411\u67085\u65e5\u3001 <strong><a href=\"https:\/\/www.hsa.gov.sg\/\">\u4fdd\u5065\u79d1\u5b66\u5c40\uff08HSA\uff09<\/a><\/strong> \u30b7\u30f3\u30ac\u30dd\u30fc\u30eb\u306f\u3001\u898f\u5236\u8981\u4ef6\u3092\u6982\u8aac\u3057\u305f\u65b0\u3057\u3044\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u3092\u767a\u8868\u3057\u307e\u3057\u305f\u3002 <strong>\u533b\u7642\u6a5f\u5668\u306e\u767b\u9332\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3001\u30b0\u30eb\u30fc\u30d7\u5316\u57fa\u6e96\u3001\u304a\u3088\u3073\u63d0\u51fa\u30d7\u30ed\u30bb\u30b9\u3002.<\/strong> \u3053\u306e\u6539\u8a02\u306f\u3001\u30b7\u30f3\u30ac\u30dd\u30fc\u30eb\u3067\u4f9b\u7d66\u3055\u308c\u308b\u533b\u7642\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3068\u6027\u80fd\u306b\u95a2\u3059\u308b\u671f\u5f85\u3092\u5f37\u5316\u3057\u3064\u3064\u3001\u898f\u5236\u306e\u30d7\u30ed\u30bb\u30b9\u3092\u5408\u7406\u5316\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001 <strong>\u88fd\u9020\u696d\u8005\u3001\u8f38\u5165\u696d\u8005\u3001\u5378\u58f2\u696d\u8005\u3001\u305d\u306e\u4ed6\u306e\u95a2\u4fc2\u8005<\/strong> \u533b\u7642\u6a5f\u5668\u306e\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u5168\u4f53\u3067\u6d3b\u52d5\u3057\u3066\u3044\u307e\u3059\u3002.<\/p>\n<div class=\"row\"  id=\"row-1955775955\">\n\n\t<div id=\"col-503296193\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3>\u66f4\u65b0\u3055\u308c\u305f\u30ac\u30a4\u30c0\u30f3\u30b9\u306e\u6982\u8981<\/h3>\n\t<div id=\"gap-597309543\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-597309543 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u65b0\u3057\u3044\u51fa\u7248\u7269\u306f\u3001 <strong>\u4f53\u5916\u8a3a\u65ad\u7528\u5206\u6790\u88c5\u7f6e\u306e\u8a31\u5bb9\u3055\u308c\u308b\u5909\u7a2e\u3068\u8a31\u5bb9\u3055\u308c\u306a\u3044\u5909\u7a2e<\/strong> \u306e\u4e0b\u3067 <strong>\u5bb6\u65cf\u30b0\u30eb\u30fc\u30d7<\/strong> \u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u3002\u8a3a\u65ad\u6a5f\u80fd\u3092\u5909\u66f4\u3059\u308b\u30d0\u30ea\u30a2\u30f3\u30c8\u306f\u500b\u5225\u306e\u30ea\u30b9\u30c8\u304c\u5fc5\u8981\u3067\u3059\u304c\u3001\u8a31\u5bb9\u3055\u308c\u308b\u30d0\u30ea\u30a2\u30f3\u30c8\u306f\u65e2\u5b58\u306e\u30eb\u30fc\u30eb\u306b\u5f93\u3063\u3066\u3088\u308a\u52b9\u7387\u7684\u306b\u30b0\u30eb\u30fc\u30d7\u5316\u3067\u304d\u307e\u3059\u3002.<\/p>\n<p>\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u306f\u3001\u4ee5\u4e0b\u306e\u8a73\u7d30\u306a\u671f\u5f85\u4e8b\u9805\u3082\u7d39\u4ecb\u3055\u308c\u3066\u3044\u308b\u3002 <strong>\u6a5f\u68b0\u5b66\u7fd2\u5bfe\u5fdc\u533b\u7642\u6a5f\u5668\u3001,<\/strong> \u30e2\u30c7\u30eb\u306e\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u3001\u691c\u8a3c\u3001\u6f5c\u5728\u7684\u306a\u8106\u5f31\u6027\u3001\u81e8\u5e8a\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3078\u306e\u7d71\u5408\u306b\u95a2\u3059\u308b\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u5316\u304c\u5fc5\u8981\u3067\u3059\u3002.<\/p>\n<p>\u306e\u305f\u3081\u306b <strong>\u63a5\u7d9a\u3055\u308c\u305f\u533b\u7642\u6a5f\u5668\u3001,<\/strong> HSA\u306f\u63d0\u51fa\u3092\u7fa9\u52d9\u4ed8\u3051\u3066\u3044\u308b <strong>\u30b5\u30a4\u30d0\u30fc\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3<\/strong> \u7d99\u7d9a\u7684\u306a\u8105\u5a01\u306e\u691c\u51fa\u3068\u7ba1\u7406\u306e\u8a08\u753b\u3068\u3068\u3082\u306b\u8a3c\u62e0\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002.<\/p>\n<p>\u3055\u3089\u306b\u3001\u3053\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u3067\u306f\u3001 <strong>ISO 13485 \u307e\u305f\u306f SS 620 (GDPMDS \u2013 \u533b\u7642\u6a5f\u5668\u306e\u9069\u6b63\u6d41\u901a\u57fa\u6e96)<\/strong> \u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u5168\u4f53\u306b\u308f\u305f\u308b\u8a8d\u8a3c\u3001\u305f\u3060\u3057 <strong>\u30af\u30e9\u30b9A\u30c7\u30d0\u30a4\u30b9<\/strong> \u7279\u5b9a\u306e\u7533\u544a\u8981\u4ef6\u3092\u6e80\u305f\u3059\u3002\u5229\u5bb3\u95a2\u4fc2\u8005\u306f\u307e\u305f\u3001\u30bf\u30a4\u30e0\u30ea\u30fc\u306a<strong> SHARE\u30b7\u30b9\u30c6\u30e0\uff08\u30b7\u30f3\u30ac\u30dd\u30fc\u30eb\u4fdd\u5065\u88fd\u54c1\u30a2\u30af\u30bb\u30b9\u304a\u3088\u3073\u898f\u5236\u96fb\u5b50\u30b7\u30b9\u30c6\u30e0\uff09\u306b\u3088\u308b\u8ca9\u58f2\u696d\u8005\u30e9\u30a4\u30bb\u30f3\u30b9\u306e\u66f4\u65b0\u3001,<\/strong> GIRO\u30e6\u30fc\u30b6\u30fc\u306f\u81ea\u52d5\u66f4\u65b0\u304c\u53ef\u80fd\u3067\u3001\u66f4\u65b0\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b <strong>\u30af\u30e9\u30b9A\u533b\u7642\u6a5f\u5668\u901a\u77e5<\/strong> \u8f38\u5165\u307e\u305f\u306f\u4f9b\u7d66\u3059\u308b\u524d\u306b\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-503296193 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1880839742\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3>\u3053\u308c\u304c\u306a\u305c\u91cd\u8981\u306a\u306e\u304b<\/h3>\n\t<div id=\"gap-1274159329\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1274159329 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u6539\u8a02\u3055\u308c\u305f\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u306f\u3001\u30c7\u30d0\u30a4\u30b9\u306e\u30b0\u30eb\u30fc\u30d7\u5316\u3001AI\u5bfe\u5fdc\u30c7\u30d0\u30a4\u30b9\u306e\u6587\u66f8\u5316\u3001\u30b5\u30a4\u30d0\u30fc\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u5bfe\u7b56\u3001\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306e\u54c1\u8cea\u8a8d\u8a3c\u306b\u3064\u3044\u3066\u3001\u3088\u308a\u660e\u78ba\u306a\u898f\u5b9a\u304c\u8a2d\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u8981\u4ef6\u306f\u3001\u898f\u5236\u306e\u4e00\u8cab\u6027\u3092\u7dad\u6301\u3057\u3001\u88fd\u54c1\u767b\u9332\u3092\u52b9\u7387\u5316\u3057\u3001\u4e0d\u5fc5\u8981\u306a\u4e8b\u52d9\u8ca0\u62c5\u3092\u751f\u3058\u3055\u305b\u308b\u3053\u3068\u306a\u304f\u3001\u30b7\u30f3\u30ac\u30dd\u30fc\u30eb\u306e\u5b89\u5168\u6027\u304a\u3088\u3073\u6027\u80fd\u57fa\u6e96\u3078\u306e\u7d99\u7d9a\u7684\u306a\u9069\u5408\u6027\u3092\u78ba\u4fdd\u3057\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1880839742 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1422708220\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3>\u3053\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u3092\u30ec\u30d3\u30e5\u30fc\u3059\u3079\u304d\u4eba<\/h3>\n\t<div id=\"gap-2081271177\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2081271177 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u3053\u306e\u51fa\u7248\u7269\u306f\u3001 <strong>\u898f\u5236\u696d\u52d9\u3001\u54c1\u8cea\u4fdd\u8a3c\u3001AI\u304a\u3088\u3073\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u958b\u767a\u30c1\u30fc\u30e0\u3001\u88fd\u9020\u696d\u8005\u3001\u8f38\u5165\u696d\u8005\u3001,<\/strong> \u305d\u3057\u3066 <strong>\u5378\u58f2\u696d\u8005<\/strong> \u30b7\u30f3\u30ac\u30dd\u30fc\u30eb\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u306e\u53d6\u308a\u6271\u3044\u3001\u7279\u306bIVD\u5206\u6790\u88c5\u7f6e\u3001\u63a5\u7d9a\u30c7\u30d0\u30a4\u30b9\u3001\u6a5f\u68b0\u5b66\u7fd2\u5bfe\u5fdc\u6280\u8853\u306e\u7ba1\u7406\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1422708220 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1603885745\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3>\u6b21\u306e\u30b9\u30c6\u30c3\u30d7<\/h3>\n\t<div id=\"gap-1795356396\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1795356396 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u5229\u5bb3\u95a2\u4fc2\u8005\u306f\u3001\u66f4\u65b0\u3055\u308c\u305fHSA\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u78ba\u8a8d\u3057\u3001\u88fd\u54c1\u5206\u985e\u304c\u4ee5\u4e0b\u306e\u57fa\u6e96\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002 <strong>\u5bb6\u65cf\u30b0\u30eb\u30fc\u30d7<\/strong> \u57fa\u6e96\u3002\u898f\u5236\u5f53\u5c40\u306f\u3001 <strong>\u6a5f\u68b0\u5b66\u7fd2\u5bfe\u5fdc\u30c7\u30d0\u30a4\u30b9<\/strong> \u304a\u3088\u3073\u63a5\u7d9a\u3055\u308c\u305f\u30c7\u30d0\u30a4\u30b9 <strong>\u30b5\u30a4\u30d0\u30fc\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u306e\u8a3c\u62e0\u3001,<\/strong> \u78ba\u8a8d\u3059\u308b <strong>ISO 13485\u307e\u305f\u306fSS 620<\/strong> \u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u5168\u4f53\u3067\u8a8d\u8a3c\u3092\u53d6\u5f97\u3057\u3001 <strong>\u30af\u30e9\u30b9A\u901a\u77e5<\/strong> \u8f38\u5165\u307e\u305f\u306f\u4f9b\u7d66\u524d\u306b\u66f4\u65b0\u3055\u308c\u307e\u3059\u3002\u7d44\u7e54\u304c\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u6226\u7565\u3092\u6539\u826f\u3059\u308b\u306b\u3064\u308c\u3066\u3001, <a href=\"https:\/\/regask.com\/ja\/\">RegASK<\/a> \u9032\u5316\u3059\u308b\u30b7\u30f3\u30ac\u30dd\u30fc\u30eb HSA \u306e\u671f\u5f85\u306b\u5fdc\u3048\u308b\u7a4d\u6975\u7684\u306a\u76e3\u8996\u3068\u8abf\u6574\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002.<\/p>\n<p>RegASK\u306f\u30ea\u30fc\u30c7\u30a3\u30f3\u30b0 <strong>\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u578bAI\u898f\u5236\u30a4\u30f3\u30c6\u30ea\u30b8\u30a7\u30f3\u30b9\u304a\u3088\u3073\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u30aa\u30fc\u30b1\u30b9\u30c8\u30ec\u30fc\u30b7\u30e7\u30f3\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0<\/strong> 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AI\u3068\u5c02\u9580\u5bb6\u306e\u77e5\u898b\u3092\u7d44\u307f\u5408\u308f\u305b\u308b\u3053\u3068\u3067\u3001\u30bf\u30a4\u30e0\u30ea\u30fc\u3067\u4e88\u6e2c\u7684\u304b\u3064\u5b9f\u7528\u7684\u306a\u30a4\u30f3\u30b5\u30a4\u30c8\u3068\u30a8\u30f3\u30c9\u30c4\u30fc\u30a8\u30f3\u30c9\u306e\u81ea\u52d5\u5316\u3092\u63d0\u4f9b\u3057\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30d7\u30ed\u30bb\u30b9\u306e\u5408\u7406\u5316\u3001\u30ea\u30b9\u30af\u306e\u8efd\u6e1b\u3001\u305d\u3057\u3066157\u30ab\u56fd\u4ee5\u4e0a\u3078\u306e\u5e02\u5834\u30a2\u30af\u30bb\u30b9\u306e\u52a0\u901f\u3092\u5b9f\u73fe\u3057\u307e\u3059\u3002.<\/p>\n<p><a href=\"https:\/\/regask.com\/ja\/%e8%a3%bd%e5%93%81\/\">\u3082\u3063\u3068\u8a73\u3057\u304f\u77e5\u308b<\/a> \u307e\u305f\u306f <a href=\"https:\/\/regask.com\/ja\/%e3%83%87%e3%83%a2%e3%82%92%e4%ba%88%e7%b4%84%e3%81%99%e3%82%8b\/\">\u4eca\u3059\u3050\u30c7\u30e2\u3092\u4e88\u7d04\u3057\u3066\u304f\u3060\u3055\u3044\u3002. 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