{"id":12242,"date":"2022-07-29T12:47:28","date_gmt":"2022-07-29T03:47:28","guid":{"rendered":"https:\/\/microncro.com\/?post_type=resources&#038;p=12242"},"modified":"2026-06-11T18:46:54","modified_gmt":"2026-06-11T09:46:54","slug":"samd-dev-flow-in-jpn","status":"publish","type":"resources","link":"https:\/\/microncro.com\/en\/resources\/samd-dev-flow-in-jpn\/","title":{"rendered":"Regulatory Process for Medical Device Software in Japan"},"content":{"rendered":"<figure style=\"width:550px;\" class=\"aligncenter wp-block-post-featured-image\"><img loading=\"lazy\" decoding=\"async\" width=\"550\" height=\"230\" src=\"https:\/\/microncro.com\/wp-content\/uploads\/2026\/05\/36_thumb_MDS-1.png\" class=\"attachment-post-thumbnail size-post-thumbnail wp-post-image\" alt=\"\" style=\"object-fit:cover;\" \/><\/figure>\n\n\n<p class=\"is-small-size\">SaMD is software used for treatment, diagnosis and prevention of disease. This flow chart describes development and regulatory application processes in Japan.<\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"591\" src=\"https:\/\/microncro.com\/wp-content\/uploads\/2026\/05\/samd-1-1024x591-1.png\" alt=\"SaMD classification and regulatory pathways in Japan\" class=\"wp-image-12327\" style=\"width:980px\" srcset=\"https:\/\/microncro.com\/wp-content\/uploads\/2026\/05\/samd-1-1024x591-1.png 1024w, https:\/\/microncro.com\/wp-content\/uploads\/2026\/05\/samd-1-1024x591-1-768x443.png 768w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n<\/div>\n\n\n<p class=\"is-small-size\">*Pharmaceuticals and Medical Devices Agency<\/p>\n\n\n\n<p class=\"is-small-size\">\u2713The need of clinical data greatly affects the time\/budget required for development.<br>\u2713Micron can propose the optimal and shortest process.<\/p>\n\n\n\n<p class=\"is-small-size\">Micron offers a full range of services for obtaining certification\/approval of SaMD, including consultation, study planning and operation, and handling of PMDA approval applications.<br>Please feel free to contact us for more information.<\/p>\n\n\n\n<p class=\"is-small-size\"><strong>Recommendations<\/strong><\/p>\n\n\n\n<p class=\"is-small-size\"><strong>White Papers<\/strong><\/p>\n\n\n\n<p class=\"is-small-size\"><a href=\"https:\/\/microncro.com\/wp-content\/uploads\/2022\/07\/315908b69f1fd586387157e2b823ff8a-1.pdf\">The Development of Software as a Medical Device: Clarification of Clinical Significance<\/a><\/p>\n\n\n\n<p class=\"is-small-size\"><strong>Articles, Services and&nbsp;Solutions<\/strong><\/p>\n\n\n\n<p class=\"is-small-size\"><a href=\"https:\/\/microncro.com\/archives\/works_en\/microns-samd\">Micron\u2019s SaMD Support Package<\/a><\/p>\n\n\n\n<p class=\"is-small-size\"><a href=\"https:\/\/microncro.com\/wp-content\/uploads\/2022\/07\/Software-as-Medical-Device-SaMD-Approval-Support-Achievements_20220517.pdf\">SaMD Approval Support Achievements<\/a><\/p>\n\n\n\n<p class=\"is-small-size\">The information contained in this document is subject to change without notice. Micron, Inc. makes no warranty of any kind with respect to this article (including, but not limited to, the implied warranties of merchantability and fitness for a particular purpose). Micron, Inc. shall not be liable for errors contained herein or for incidental or consequential damages in connection with the provision, performance, or use of this document.<\/p>\n\n\n\n<p class=\"is-small-size\">This article was written on 27 Jun 2022.<\/p>\n\n\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button is-dark-color is-large-size\" href=\"https:\/\/microncro.com\/en\/resources\/\">View Resources<\/a><\/div>\n\n\n\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button is-dark-color is-large-size\" href=\"https:\/\/microncro.com\/en\/contact\/\">Contact Us<\/a><\/div>\n<\/div>\n\n\n\n\n<div class=\"micron-share\">\n\t<div class=\"micron-share-inner\">\n\t\t<h2 class=\"micron-share-title\">Share<\/h2>\n\t\t<ul class=\"micron-share-buttons\">\n\t\t\t<li><a class=\"micron-share-button-linkedin\" href=\"https:\/\/www.linkedin.com\/sharing\/share-offsite\/?url=https:\/\/microncro.com\/en\/resources\/samd-dev-flow-in-jpn\/\" rel=\"nofollow\" target=\"_blank\">LinkedIn \u3067\u30b7\u30a7\u30a2\u3059\u308b<\/a><\/li>\n\t\t<\/ul>\n\t<\/div>\n<\/div>\n\n\n\t<div class=\"micron-related-posts\">\n\t\t<div class=\"micron-related-posts-inner\">\n\t\t\t<h2 class=\"wp-block-heading\">Related Articles<\/h2>\n\t\t\t<ul>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li>\n\t\t\t\t\t\t\t<a href=\"https:\/\/microncro.com\/en\/resources\/mvp17\/\" target=\"_blank\">\n\t\t\t\t\t\t\t\t<div class=\"micron-related-post-image\">\n\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/microncro.com\/wp-content\/themes\/micron\/assets\/images\/no-image.svg\" width=\"410\" height=\"231\" alt=\"\">\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"micron-related-post-title\">\n\t\t\t\t\t\t\t\t\t<div class=\"micron-related-post-title-inner\">\n\t\t\t\t\t\t\t\t\t\tThe Development of Software as a Medical Device (SaMD) -Clarification of Clinical Significance-\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li>\n\t\t\t\t\t\t\t<a href=\"https:\/\/microncro.com\/en\/solutions\/samd_development_support\/\" target=\"_blank\">\n\t\t\t\t\t\t\t\t<div class=\"micron-related-post-image\">\n\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/microncro.com\/wp-content\/themes\/micron\/assets\/images\/no-image.svg\" width=\"410\" height=\"231\" alt=\"\">\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"micron-related-post-title\">\n\t\t\t\t\t\t\t\t\t<div class=\"micron-related-post-title-inner\">\n\t\t\t\t\t\t\t\t\t\tSaMD Development Support\u200b\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li>\n\t\t\t\t\t\t\t<a href=\"https:\/\/microncro.com\/en\/solutions\/mah_dmah\/\" target=\"_self\">\n\t\t\t\t\t\t\t\t<div class=\"micron-related-post-image\">\n\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/microncro.com\/wp-content\/themes\/micron\/assets\/images\/no-image.svg\" width=\"410\" height=\"231\" alt=\"\">\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"micron-related-post-title\">\n\t\t\t\t\t\t\t\t\t<div class=\"micron-related-post-title-inner\">\n\t\t\t\t\t\t\t\t\t\tMAH\u30fbDMAH\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t\t<\/div>\n\t<\/div>\n\t","protected":false},"featured_media":12330,"menu_order":19,"template":"","meta":{"_acf_changed":false,"_locale":"en_US","_original_post":"https:\/\/microncro.com\/?post_type=resources&p=12242","footnotes":""},"content-type":[9],"service":[12],"keyword":[26],"class_list":["post-12242","resources","type-resources","status-publish","has-post-thumbnail","hentry","en-US"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - 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