{"id":18274,"date":"2021-05-25T16:47:38","date_gmt":"2021-05-25T14:47:38","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=18274"},"modified":"2023-01-25T17:24:49","modified_gmt":"2023-01-25T16:24:49","slug":"updates-eac-certificate-registration-procedure-russia","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2021\/05\/25\/updates-eac-certificate-registration-procedure-russia\/","title":{"rendered":"RUSSIA: updates in the EAC Certificate Registration Procedure"},"content":{"rendered":"\r\n<p>From January 2021 new requirements have come into force to obtain the <strong>EAC Certificate (EurAseC Conformity)<\/strong>,<strong> which is essential for commercializing products in Russia<\/strong>.<\/p>\r\n\r\n\r\n\r\n<p>The new procedure is valid both for EAC (TR CUs) and Russian National approval documents (GOST R, National Fire Safety Certificates, etc.) registered in Russia. The EAC certificates registration procedure in other Eurasian Economic Community countries (Belarus, Kazakhstan, Armenia, Kyrgyzstan) remains as it was.<\/p>\r\n\r\n\r\n\r\n<p>According to the new procedures, in order to obtain the EAC Certificate the applicant must provide various information, detailed below.<\/p>\r\n\r\n\r\n\r\n<figure class=\"wp-block-image\"><img decoding=\"async\" class=\"wp-image-18195\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2021\/05\/russia-certificato-eac-1024x536.png\" alt=\"Russia updates in the EAC Certificate Registration Procedure\" \/>\r\n<figcaption>Updates in the EAC Certificate Registration Procedure<\/figcaption>\r\n<\/figure>\r\n\r\n\r\n\r\n<h2 class=\"wp-block-heading\"><strong>What is the EAC Certificate of conformity?<\/strong><\/h2>\r\n\r\n\r\n\r\n<p>The <strong>EAC Certificate of conformity<\/strong> confirms that devices comply with the Technical Regulations of the Eurasian Economic Community (EURASEC).<\/p>\r\n\r\n\r\n\r\n<p>Products that bear the <strong>EAC Mark<\/strong> have all passed the conformity assessment procedures in one of the Member States of the Eurasian Economic Community and they also comply with the technical requirements. Therefore, they can circulate freely within the Customs Area without further restrictions or constraints.<\/p>\r\n\r\n\r\n\r\n<p>The Eurasian Economic Community includes Russia, Belarus, Kazakhstan, Armenia and Kyrgyzstan.<\/p>\r\n\r\n\r\n\r\n<h2 class=\"wp-block-heading\"><strong>What does the EAC Certificate Registration Procedure involve starting from 2021?<\/strong><\/h2>\r\n\r\n\r\n\r\n<p><strong>From 1 January 2021<\/strong> the <strong>registration number of the customs declaration<\/strong> of the cargo is required in order to move goods beyond customs. Note that the customs registration number is assigned when the custom declaration is accepted, that is, when the applicant expresses the intention to place the goods under a certain customs procedure.<\/p>\r\n\r\n\r\n\r\n<p><strong>From 1 August 2021<\/strong> in order to register the EAC Certificate, the applicant must provide the following information:<\/p>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li><strong>Name and address of the Manufacturer<\/strong>, with <strong>mention of GLN (Global Location Number),<\/strong> that is the unique code that identifies the company, for products manufactured outside the Customs Union;<\/li>\r\n<li>The <strong>GTIN (Global Trade Item Number),<\/strong> that is the product code that identifies the <strong>goods<\/strong>, mentioned also in the product information section;<\/li>\r\n<li><strong>Data<\/strong> on <strong>annual inspections<\/strong>.<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<p>Because of the implementation of these new procedures, it is probable to have delays in the registration of EAC certificates.<\/p>\r\n\r\n\r\n\r\n<h2 class=\"wp-block-heading\"><strong>Possible further normative amendments<\/strong> <strong>on Medical Devices in Russia<\/strong><\/h2>\r\n\r\n\r\n\r\n<p>In <strong>April 2021<\/strong>, the Russian Parliament discussed several <strong>amendments<\/strong> made to the <strong>Federal Law No. 323 \u201cOn health care protection\u201d<\/strong>, related to the <strong>regulation of Medical Devices<\/strong>.<\/p>\r\n\r\n\r\n\r\n<p>The aforementioned amendments have been approved and are part of a <strong>published draft law<\/strong> that has not entered into force yet.<\/p>\r\n\r\n\r\n\r\n<p>Moreover, a <strong>proposal from the Russian government<\/strong> was recently discussed regarding the <strong>draft regulation<\/strong> that proposes the <strong>simplification of the national registration process<\/strong> (a faster one-step registration) for <strong>Russian Manufacturers<\/strong> on the condition that the performance type test, supervised by the Russian healthcare regulator Roszdravnadzor, is performed in the testing laboratory of the expert body.<\/p>\r\n\r\n\r\n\r\n<p>Finally, <strong>within the end of May 2021 another amendment<\/strong> <strong>should be discussed<\/strong> regarding <strong>Quality Management Systems<\/strong> for Medical Devices Manufacturers. According to the draft document, the quality management audit could be performed remotely, as long as there is a standard audit within 2 years from the virtual inspection.<\/p>\r\n\r\n\r\n\r\n<h2 class=\"wp-block-heading\"><strong>Do you need support to register your devices in Russia?<\/strong><\/h2>\r\n\r\n\r\n\r\n<p><strong><a href=\"mailto:sales@thema-group.it\">Contact us<\/a><\/strong> for further information!<\/p>\r\n\r\n\r\n\r\n<p><em>Source:<\/em><\/p>\r\n\r\n\r\n\r\n<p><a href=\"https:\/\/sozd.duma.gov.ru\/bill\/1080292-7\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\">Russian legal support system<\/a><\/p>\r\n","protected":false},"excerpt":{"rendered":"<p>From January 2021 new requirements have come into force to obtain the EAC Certificate (EurAseC Conformity), which is essential for commercializing  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":23071,"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":[2],"tags":[],"class_list":["post-18274","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Updates in the EAC Certificate Registration Procedure in Russia<\/title>\n<meta name=\"description\" content=\"From January 2021 new requirements have come into force to obtain the EAC Certificate, which is essential for commercializing products in Russia.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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