{"id":7209,"date":"2017-09-19T13:22:52","date_gmt":"2017-09-19T10:22:52","guid":{"rendered":"http:\/\/wwwen.anm.ro\/?page_id=7209"},"modified":"2026-02-24T14:23:41","modified_gmt":"2026-02-24T11:23:41","slug":"legi-ordonante-si-hotarari-de-guvern","status":"publish","type":"page","link":"https:\/\/www.anm.ro\/en\/dispozitive-medicale\/legislatie\/legi-ordonante-si-hotarari-de-guvern\/","title":{"rendered":"Laws, ordinances and government decisions – Medical Devices"},"content":{"rendered":"

> Laws, ordinances and government decisions<\/a>
\n> Orders of the minister of health<\/a>
\n> Directives and regulations<\/a>
\n> Scientific council decisions<\/a><\/p>\n

LAWS<\/b><\/span><\/p>\n

2023<\/strong><\/p>\n\n\n\n
LAW No. 289 of 23 October 2023 on approval of Emergency Government Ordinance no. 137\/2022 on establishment of the institutional framework, as well as the measures necessary for the implementation of the provisions of Regulation (EU) 2017\/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98\/79\/EC and Commission Decision 2010\/227\/EU
\nPublished in: the Official Gazette of Romania No. 961 of 24 October 2023
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2006<\/strong><\/p>\n\n\n\n\n
LAW No. 95 republished on 14 April 2006 on healthcare reform,
\ncontaining all amendments brought to the official document published in the Official Gazette of Romania, including those mentioned in: Government ordinance No. 37\/31.08.2022 published in the Official Gazette of Romania No. 857\/31.08.2022
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Title XX of Law 95\/2006 \u2013 version published in the Official Gazette of Romania No. 391\/21.04.2022
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\nORDINANCES<\/b><\/span><\/p>\n

2022<\/strong><\/p>\n\n\n\n\n
EMERGENCY ORDINANCE no. 137 of 12 October 2022 on establishment of the institutional framework, as well as the measures necessary for the implementation of the provisions of Regulation (EU) 2017\/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98\/79\/EC and Commission Decision 2010\/227\/EU
\nPublished in: The Official Gazette of Romania, No. 995 of 13 October 2022
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ORDINANCE No. 37 of 31 August 2022 on amendment and supplementation of Law No. 95\/2006 on healthcare reform and of Law No. 227\/2015 regarding the Fiscal code, and on establishment of other measures in the healthcare field
\nPublished in: the Official Gazette No. 857 of 31 August 2022
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2021<\/strong><\/p>\n\n\n\n
EMERGENCY ORDINANCE No. 46 of 9 June 2021 on establishment of an institutional framework and measures for enforcement 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
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\nGOVERNMENT DECISIONS<\/span><\/b><\/p>\n

2011<\/strong><\/p>\n\n\n\n
Government Decision no. 306 of 23 March 2011 on measures for the surveillance of the market for products under European Union regulation for harmonised marketing
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2009<\/strong><\/p>\n\n\n\n\n
Government Decision no. 55 of 29 January 2009 on active implantable medical devices, as amended
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Government Decision no. 54 of 29 January 2009 on conditions for placing on the market of medical devices, as amended
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2003<\/strong><\/p>\n\n\n\n
Government Decision no. 798 of 3 July 2003 on establishment of conditions for placing on the market of in vitro diagnostic medical devices and their use, as amended
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> Laws, ordinances and government decisions > Orders of the minister of health > Directives and regulations > Scientific council […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":4802,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-7209","page","type-page","status-publish","hentry"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/7209","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/types\/page"}],"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=7209"}],"version-history":[{"count":3,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/7209\/revisions"}],"predecessor-version":[{"id":9575,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/7209\/revisions\/9575"}],"up":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/4802"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=7209"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}