{"id":3435,"date":"2013-07-18T04:44:59","date_gmt":"2013-07-18T04:44:59","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=3435"},"modified":"2013-07-18T04:44:59","modified_gmt":"2013-07-18T04:44:59","slug":"south-korea-mfds-amends-its-medical-devices-act-will-require-iec-60601-1-3rd-ed-amendments","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2013\/07\/18\/south-korea-mfds-amends-its-medical-devices-act-will-require-iec-60601-1-3rd-ed-amendments\/","title":{"rendered":"South Korea MFDS Amends it\u2019s Medical Devices Act &#038; Will Require IEC 60601-1, 3rd ed + Amendments"},"content":{"rendered":"<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">There were three major changes to South Korea\u2019s Medical Devices Act and the Enforcement of the Medical Devices Act as of 8 May 2013.<\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><!--more--><\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong><span style=\"text-decoration: underline;\">Introduction of IEC 60601-1 (third edition) with amendments<\/span><\/strong><\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">They will be requiring that for electrical medical devices these products will need to meet IEC 60601-1, 3<sup>rd<\/sup> ed. (2005) + Amendments*.\u00a0 \u00a0This requirement is effective for Class 3 &amp; 4 medical devices as of June 1 2014, for Class 2 medical devices as of June 1 2015 and lastly for Class 1 medical devices as of June 1 2016.<\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">* Depending on what this Amendment to the Medical Devices Act consider Amendments it could be just Amendments of the standard or it could include &amp; probably should consider the Corrigendums and Interpretation Sheets too.\u00a0 \u00a0All the possible current Amendments are Amendment 1:2012 + Corrigendums 1:2006 and 2:2007 for 3<sup>rd<\/sup> ed. and Corrigendum 1:2012 for ed. 3.1 + Interpretation Sheets 1:2008, 2:2009, &amp; 3:2013.<\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">The notice also states that MFDS will lay down new safety standards for software as medical electrical equipments.\u00a0 My guess is that they will require complying with IEC 62304 which is the standard for Medical Device Software Lifecycles as it has become very popular around the world for many national regulatory bodies.\u00a0 We will have to wait and see what happens for this requirement, as the notice is not clear as to what standard(s) they will use as of now.<\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong><span style=\"text-decoration: underline;\">Introduction of the Summary Technical Documentation (STED)<\/span><\/strong><\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">As of January 1 2014 Class 4 medical device applicants (except for IVD reagents) will be required to submit in the the STED format.\u00a0 MFDS says that this will expedite the review timelines for the manufacturers and devices that are submitted.\u00a0 Class 1, 2, &amp; 3 devices have the option of submitting in the STED format as of the date for the notification.<\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong><span style=\"text-decoration: underline;\">Revised \u201cRegulations on Classification and Grades\u201d<\/span><\/strong><\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">MFDS announced several changes for the regulations on classification and grades covering the following issues:<\/span><\/p>\n<ul>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">94 new products are added under &#8220;cell manipulating kit for medical use&#8221;.<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">Definitions for 108 products have changed including for \u201cheater systems\u201d.<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">The Class of \u201cdental color measuring devices\u201d was down-classified to Class\u00a01.<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">67 commercial names including \u201cwarm bath equipment\u201d are edited out.<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">The changes are effective as of the date of notification.<\/span><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>There were three major changes to South Korea\u2019s Medical Devices Act and the Enforcement of the Medical Devices Act as of 8 May 2013.<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1],"tags":[1060,402,61,15,16,59,688,689,690,576,403,609,610,611,41,47,404,924,1061,163,92,63,64,1062,27,185,206,9,13,617,218,842,414,624,582,53,94,60,1063,1064,1065,22,174,175,956,149,1066,1067,1068,1069,631,1070,1071,1072,1073,1074],"class_list":["post-3435","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-3rd-ed-2005-amendments","tag-402","tag-60601-series","tag-60601-1","tag-60601-1-3rd-ed","tag-60601-1-3rd-ed-amendment-1","tag-60601-1-a1-12","tag-60601-1-a1-2012","tag-60601-1-a112","tag-576","tag-a1","tag-a1-iec-60601-1-3rd-ed","tag-a1-iec-60601-1-3rd-edition","tag-a1-iec-60601-12005","tag-aami-es60601-1","tag-aami-es60601-1c1","tag-amendment-1","tag-amendment-1-to-iec-60601-12005","tag-amendments","tag-ansiaami-es60601-1","tag-collateral-standard","tag-en60601","tag-en60601-1","tag-enforcement-of-the-medical-devices-act","tag-escnews","tag-eu","tag-european-commission","tag-fda","tag-iec","tag-iec-60601","tag-iec-60601-1","tag-iec-60601-1-a1","tag-iec-60601-1-3rd-ed","tag-iec-60601-105","tag-iec-62304","tag-iec60601-1","tag-iec60601-1-3rd-ed","tag-iec60601-1-3rd-ed-amendment-1","tag-kfda","tag-korea","tag-koreas-ministry-of-food-and-drug-safety","tag-medical","tag-medical-device-industry","tag-medical-device-regulatory","tag-medical-device-software","tag-medical-devices","tag-medical-devices-act","tag-mfds","tag-ministry-of-food-and-drug-safety","tag-regulatory-bodies","tag-safety-standards","tag-software-lifecycles","tag-south-korea","tag-south-koreas-ministry-of-food-and-drug-safety","tag-sted","tag-summary-technical-documentation"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/3435","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/comments?post=3435"}],"version-history":[{"count":0,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/3435\/revisions"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=3435"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=3435"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=3435"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}