{"id":20506,"date":"2022-03-29T09:37:05","date_gmt":"2022-03-29T07:37:05","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=20506"},"modified":"2022-03-28T10:42:06","modified_gmt":"2022-03-28T08:42:06","slug":"japan-ok-mdsap-report-starting-from-1st-april-2022","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2022\/03\/29\/japan-ok-mdsap-report-starting-from-1st-april-2022\/","title":{"rendered":"JAPAN: OK MDSAP report starting from 1st April 2022"},"content":{"rendered":"\n<p><strong>Japan\u2019s Ministry of Health, Labour, and Welfare (MHWL)<\/strong> has updated its processes and procedures in order to <strong>officially accept MDSAP reports starting from 1<sup>st<\/sup> April 2022, <\/strong>as evidence of conformity of the quality management system required for Medical Devices registration procedures.<\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/03\/giappone-ok-report-mdsap-1-aprile-2022-e1648538654219-1024x536.jpg\" alt=\"Japan ok MDSAP report starting from 1st April 2022\" class=\"wp-image-20481\"\/><figcaption>OK MDSAP report starting from 1st April 2022<\/figcaption><\/figure>\n\n\n\n<p>Please remember\nthat the <strong>Medical Device Single Audit Program<\/strong> (<strong>MDSAP<\/strong>) is a program\nthat allows Bodies accredited by the Regulatory Authorities of member countries\n(US, Canada, Australia, Brazil, and Japan) to conduct a <strong>single audit<\/strong> to\nverify that Medical Devices Manufacturers comply with the quality management\nsystem requirements of the relevant countries.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>What will change in Japan starting\nfrom 1<sup>st<\/sup> April?<\/strong><\/h2>\n\n\n\n<p>In the past, to\nobtain a Medical Device registration certificate, the Japanese Regulatory\nAuthority conducted a document review and an audit in the company.<\/p>\n\n\n\n<p>As from 1<sup>st<\/sup>\nApril 2022, with MDSAP reports official acceptance, the process will be\nsimplified since the Regulatory Authority will only conduct the document\nreview.<\/p>\n\n\n\n<p>However, <strong>not\nall Medical Devices<\/strong> can benefit from this simplified process. There is\nindeed a number of devices that remain excluded, such as products containing\nanimal tissues, radioactive IVD devices, and all sites that reprocess\nsingle-use devices.<\/p>\n\n\n\n<p>It should be\nnoted that an <strong>additional fee<\/strong> must be paid in order to use the MDSAP\nreport in Japan.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>What to do once MDSAP is implemented?<\/strong><\/h2>\n\n\n\n<p>It is advisable\nto <strong>always<\/strong> stay <strong>up to date <\/strong>on what changes may be occurring in\nMDSAP countries. For this reason, we recommend following the <strong>regulatory\nrequirements of the MDSAP reference countries<\/strong> through the Regulatory\nAuthorities\u2019 websites, and relevant newsletters to keep up to date from a\nregulatory perspective.&nbsp; <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Did you know that Thema can support you in implementing and adjusting your quality management system to MDSAP requirements?<\/strong><\/h2>\n\n\n\n<p>Thanks to many years of experience in the field, our consultants can assist you in <strong><a href=\"https:\/\/www.thema-med.com\/en\/services\/quality-and-international-gmps\/\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"implementing the quality system (si apre in una nuova scheda)\">implementing the quality system<\/a><\/strong> for Medical Devices, in accordance with the requirements set out in the regulations of the relevant country.<\/p>\n\n\n\n<p><strong><a href=\"mailto:sales@thema-med.com\">Contact us<\/a><\/strong> for further information and <strong><a href=\"https:\/\/www.thema-med.com\/en\/newsletter\/\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"subscribe to our newsletter (si apre in una nuova scheda)\">subscribe to our newsletter<\/a><\/strong>!<\/p>\n\n\n\n<p><em>Source:<\/em><\/p>\n\n\n\n<p><a href=\"https:\/\/www.mhlw.go.jp\/hourei\/doc\/tsuchi\/T211001I0010.pdf\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"Acceptance of MDSAP reports, MHLW, in force from April 1, 2022 (si apre in una nuova scheda)\">Acceptance of MDSAP reports, MHLW, in force from April 1, 2022<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Japan\u2019s Ministry of Health, Labour, and Welfare (MHWL) has updated its processes and procedures in order to officially accept MDSAP reports  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1,3],"tags":[],"class_list":["post-20506","post","type-post","status-publish","format-standard","hentry","category-news","category-news-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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