{"id":3014,"date":"2021-10-27T09:48:42","date_gmt":"2021-10-27T01:48:42","guid":{"rendered":"https:\/\/regask.com\/?p=3014"},"modified":"2024-10-26T03:19:36","modified_gmt":"2024-10-25T19:19:36","slug":"%e3%82%ab%e3%83%8a%e3%83%80%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8%e8%a6%8f%e5%88%b6","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/canada-medical-device-regulations\/","title":{"rendered":"\u30ab\u30ca\u30c0\u4fdd\u5065\u7701\u304c\u79c1\u306b\u95a2\u3059\u308b\u7279\u5b9a\u306e\u898f\u5236\u3092\u6539\u6b63\u3057\u307e\u3057\u305f\u2026"},"content":{"rendered":"<p>2021 \u5e74 8 \u6708 11 \u65e5\u3001HSA \u306f\u30ab\u30ca\u30c0\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u304a\u3088\u3073\u533b\u85ac\u54c1\u306e\u4e0d\u8db3\u306b\u95a2\u3059\u308b\u98df\u54c1\u533b\u85ac\u54c1\u898f\u5247\u304a\u3088\u3073\u533b\u7642\u6a5f\u5668\u898f\u5247\u3092\u6539\u6b63\u3057\u3001\u3053\u306e\u6539\u6b63\u306f 2021 \u5e74 9 \u6708 1 \u65e5\u306e\u30ab\u30ca\u30c0\u5b98\u5831\u7b2c II \u90e8\u306b\u63b2\u8f09\u3055\u308c\u307e\u3057\u305f\u3002<\/p>\n<p>\u3053\u308c\u3089\u306e\u65b0\u3057\u3044\u898f\u5236\u306f\u30012 \u3064\u306e\u66ab\u5b9a\u547d\u4ee4 (IO) \u3092\u901a\u3058\u3066\u3059\u3067\u306b\u5b9f\u65bd\u3055\u308c\u3066\u3044\u308b\u7279\u5b9a\u306e\u63aa\u7f6e\u3092\u62e1\u5f35\u304a\u3088\u3073\u4fee\u6b63\u3059\u308b\u3082\u306e\u3067\u3059\u3002\u3053\u308c\u3089\u306e\u898f\u5236\u306f\u3001\u533b\u85ac\u54c1\u3084\u533b\u7642\u6a5f\u5668\u306a\u3069\u3001\u30ab\u30ca\u30c0\u306b\u304a\u3051\u308b\u4e3b\u8981\u306a\u5065\u5eb7\u88fd\u54c1\u306e\u4e0d\u8db3\u3092\u8ffd\u8de1\u3001\u9632\u6b62\u3001\u7de9\u548c\u3059\u308b\u305f\u3081\u306b\u5236\u5b9a\u3055\u308c\u307e\u3057\u305f\u3002<\/p>\n<p>\u767a\u52b9\u65e5 <strong>2021\u5e7411\u670827\u65e5<\/strong>\u306f\u3001\u4ee5\u4e0b\u306e\u898f\u5b9a\u304c\u3042\u308b\u3002<\/p>\n<ul>\n<li>\u30ab\u30ca\u30c0\u5e02\u5834\u5411\u3051\u306e\u533b\u85ac\u54c1\u306e\u30ab\u30ca\u30c0\u56fd\u5916\u3067\u306e\u6d41\u901a\u3092\u7981\u6b62\u3057\u3001\u4e0d\u8db3\u3092\u5f15\u304d\u8d77\u3053\u3057\u305f\u308a\u60aa\u5316\u3055\u305b\u305f\u308a\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3002<\/li>\n<li>\u5927\u81e3\u304c\u533b\u85ac\u54c1\u4e0d\u8db3\u306b\u95a2\u3059\u308b\u60c5\u5831\u3092\u5f37\u5236\u7684\u306b\u63d0\u4f9b\u3067\u304d\u308b\u3088\u3046\u306b\u3059\u308b\u3002<\/li>\n<\/ul>\n<p>\u767a\u52b9\u65e5 <strong>2022\u5e743\u67081\u65e5<\/strong>\u306f\u3001\u4ee5\u4e0b\u306e\u4e8b\u9805\u306b\u95a2\u3059\u308b\u898f\u5b9a\u3067\u3042\u308b\u3002<\/p>\n<ul>\n<li>\u533b\u85ac\u54c1\u3001\u533b\u7642\u6a5f\u5668\u3001<\/li>\n<li>\u7279\u5b9a\u533b\u7642\u6a5f\u5668\u306e\u4e0d\u8db3\u306b\u95a2\u3059\u308b\u5831\u544a\u7fa9\u52d9\u304a\u3088\u3073\u533b\u7642\u6a5f\u5668\u306e\u4e0d\u8db3\u306b\u95a2\u3059\u308b\u60c5\u5831\u63d0\u4f9b\u3092\u5f37\u5236\u3059\u308b\u6a29\u9650\u3001<\/li>\n<li>\u4e00\u90e8\u306e\u85ac\u5264\u30d9\u30fc\u30b9\u306e\u624b\u6307\u6d88\u6bd2\u5264\u306b\u5bfe\u3059\u308b\u30e9\u30a4\u30bb\u30f3\u30b9\u306e\u67d4\u8edf\u6027\u306e\u62e1\u5927\u3002<\/li>\n<\/ul>\n<p>\u533b\u7642\u6a5f\u5668\u898f\u5236\u306e\u5909\u66f4\u306b\u3064\u3044\u3066\u8a73\u3057\u304f\u306f\u3001RegASK \u306b\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\u3002 <a href=\"https:\/\/regask.com\/ja\/%e6%8e%a5%e8%a7%a6\/\" target=\"_blank\" rel=\"noopener\">RegASK \u306e\u5c02\u9580\u5bb6\u306b\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\u3002<\/a><\/p>\n<p>&nbsp;<\/p>\n<a href=\"https:\/\/regask.com\/ja\/%e6%8e%a5%e8%a7%a6\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>\u8a73\u7d30\u306b\u3064\u3044\u3066\u306fRegASK\u306b\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044<\/span>\n\t<\/a>\n\n<a href=\"https:\/\/www.gazette.gc.ca\/rp-pr\/p2\/2021\/2021-09-01\/html\/sor-dors199-eng.html\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>\u7d9a\u304d\u3092\u8aad\u3080<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-1091921964\">\n\n\t<div id=\"col-1064570902\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/regask.com\/ja\/%e3%82%b1%e3%83%bc%e3%82%b9%e3%82%b9%e3%82%bf%e3%83%87%e3%82%a3-2\/%e3%83%aa%e3%82%bd%e3%83%bc%e3%82%b9-%e3%82%b1%e3%83%bc%e3%82%b9%e3%82%b9%e3%82%bf%e3%83%87%e3%82%a3-%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>\u533b\u7642\u6a5f\u5668\u696d\u754c\u306e\u30b1\u30fc\u30b9\u30b9\u30bf\u30c7\u30a3\u3092\u8aad\u3080<\/span>\n\t<\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>On 11 August 2021, HSA amended the Food and Drug Regulations and Medical Devices Regulations concerning shortages of Medical Devices and Medicinal Drugs in Canada, the amendment was published in the Canada Gazette, Part II on 1 September 2021. These new regulations extend and modify certain measures already in place through 2 interim orders (IOs). They have been made to help track, prevent and mitigate shortages of key health products in Canada, including drugs and medical devices. Coming into force on 27 November 2021, are provisions that: Prohibit the distribution of drugs intended for the Canadian market outside of Canada that could cause or worsen a shortage, Allow the Minister&#8230;<\/p>","protected":false},"author":39,"featured_media":2976,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[513,39],"tags":[40],"class_list":["post-3014","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-canada-regulations","category-medical-devices-insights","tag-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Canada Amends Medical Device Regs | RegASK<\/title>\n<meta name=\"description\" content=\"Health Canada amends regulations concerning medical devices. 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