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ORDERS OF THE MINISTER OF HEALTH
2023
| ORDER no. 80 of 12 January 2023 on approval of the structure and the Regulation for organisation and operation of the National Bioethics Committee for Medicinal Products and Medical Devices descarca documentul …  |
| Order of the Minister of Health no. 330/2023 on approval of the Methodological rules for clinical assessment and clinical investigations with medical devices and on repeal of Order of the Minister of Public Health no. 792/2006 on the conduct of the clinical investigation procedure and the performance assessment procedure for medical devices descarca documentul … |
2022
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ORDER No. 3969 of 28 December 2022 on approval of the Methodological Rules for assessment, designation and notification of the bodies assessing medical device compliance, as well as for monitoring and reassessment of notified bodies download document …
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ORDER No. 3.467 of 17 November 2022 on approval of the tariffs for the activities carried out by the National Agency for Medicines and Medical Devices of Romania (NAMMDR) in the field of medical devices Published in: The Official Gazette of Romania, no. 1.123 of 22 November 2022 download document …
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ORDER No. 2.845 of 29 September 2022 on approval of the Methodological rules 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 Published in: the Official Gazette no. 977 of 7 October 2022 download document …
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Order of the Minister of Health no. 2.242/2022 on approval of the procedure for grant of out-of-scope notices for products which do not fall under the scope 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 …
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Order of the Minister of Health no. 1.171/2022 on approval of the procedure for issuance of certificates of free sale for medical devices download document …
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2021
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ORDER No. 2.882 of 23 December 2021 on the manner of reporting suspected serious incidents related to medical devices Published in: the Official Gazette of Romania no. 1.226 of 24 December 2021 download document …
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2020
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Order of the Minister of Health no. 566/2020 for approval of the Methodological Norms for application of Title XX of Law no. 95/2006 on healthcare reform, regarding the approval of activities in the field of medical devices download document …
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2016
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Order of the Minister of Health no. 1009/2016 on record of medical devices into the national database download document …
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Order of the Minister of Health no. 1008/2016 on approval of Implementation Rules relating to provisions of Title XX – Medical Devices of Law no. 95/2006 on healthcare reform, as republished, regarding approval of medical device-related activities download document …
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2015
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Order of the Minister of Health no. 874/2015 on approval of forms for declaration of sponsoring activities related to medical devices and healthcare materials descarca documentul …
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Order of the Minister of Health no. 308/2015 on control by periodic verification of commissioned and in-use medical devices download document …
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2014
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Order of the Minister of Health no. 373 of 26.03.2014 on approval of the Special Form for the record of findings and penalty report on contraventions, on violation of legal provisions on medical devices and related activitie download document …
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2013
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Order of the Minister of Health no. 1356/2013 on approval of fees of the National Agency for Medicines and Medical Devices for medical devices-related activities download document …
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2011
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Order of the Minister of Health no. 1032/2011 on approval of Rules for donation of medicinal products, healthcare materials, medical devices, vaccines, sera and related consumables download document …
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2006
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Order of the Minister of Health no. 792 of 29 June 2006 on conduct of the procedure for clinical investigation and the procedure for assessment of performance relating to medical devices, as amended download document …
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