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LAWS
2023
| 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 Published in: the Official Gazette of Romania No. 961 of 24 October 2023 download document …  |
2006
| LAW No. 95 republished on 14 April 2006 on healthcare reform, containing 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 download document … |
| Title XX of Law 95/2006 – version published in the Official Gazette of Romania No. 391/21.04.2022 download document … |
ORDINANCES
2022
| 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 Published in: The Official Gazette of Romania, No. 995 of 13 October 2022 download document … |
| 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 Published in: the Official Gazette No. 857 of 31 August 2022 download document … |
2021
| 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 download document … |
GOVERNMENT DECISIONS
2011
| 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 download document … |
2009
| Government Decision no. 55 of 29 January 2009 on active implantable medical devices, as amended download document … |
| Government Decision no. 54 of 29 January 2009 on conditions for placing on the market of medical devices, as amended download document … |
2003
| 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 download document … |