{"id":9623,"date":"2022-10-10T08:00:53","date_gmt":"2022-10-10T05:00:53","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?p=9623"},"modified":"2022-11-09T11:25:04","modified_gmt":"2022-11-09T08:25:04","slug":"important-notification-10-10-2022","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/important-notification-10-10-2022\/","title":{"rendered":"Important notification"},"content":{"rendered":"<p><strong>10.10.2022<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of manufacturers of custom-made devices, based in Romania<\/strong><\/span><br \/>\nPlease be informed that Order No. 2845 of 29 September 2022 on approval of the Methodological norms for approval of provisions of Article 13 of Emergency Government Ordinance no. 46\/2021 on the establishment of the institutional framework and the measures necessary to ensure the direct application of the provisions of Regulation (EU) 2017\/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001\/83\/EC, Regulation (EC) no. 178\/2002 and Regulation (EC) no. 1223\/2009 and repealing Council Directives 90\/385\/EEC and 93\/42\/EEC, on registration of custom-made devices placed on the market under their own name by manufacturers based in Romania was published in the Official Gazette of Romania No. 977 of 7 October 2022.<br \/>\nThis Order is available online under section <a href=\"https:\/\/www.anm.ro\/en\/dispozitive-medicale\/legislatie\/ordine-de-ministru\/\" rel=\"noopener\" target=\"_blank\">Legislation\/Medical devices\/Orders of the Minister of health<\/a>.<br \/>\nThe request form can be downloaded from <a href=\"https:\/\/www.anm.ro\/en\/dispozitive-medicale\/formulare-si-tarife\/\" rel=\"noopener\" target=\"_blank\">Forms and tariffs \u2013 Medical Devices<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>10.10.2022 To the attention of manufacturers of custom-made devices, based in Romania Please be informed that Order No. 2845 of [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[9],"tags":[],"class_list":["post-9623","post","type-post","status-publish","format-standard","hentry","category-anunturi-importante-dispozitive-medicale"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/9623","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/comments?post=9623"}],"version-history":[{"count":1,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/9623\/revisions"}],"predecessor-version":[{"id":9624,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/9623\/revisions\/9624"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=9623"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=9623"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=9623"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}