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Legislation
In order to properly fulfill our functions and responsibilities, we have a good command of Ukrainian legislation. Since Ukraine chose the path of European integration, and since the Technical Regulations on medical products are based on the EU Directives, we are also free to use the relevant European legislation.
Basic normative acts:
Law of Ukraine "On State Market Surveillance and Control of Non-Food Products"
http://zakon2.rada.gov.ua/laws/show/2735-17
Law of Ukraine "On general safety of non-food products"
http://zakon3.rada.gov.ua/laws/show/2736-17
Law of Ukraine "On Technical Regulations and Conformity Assessment"
http://zakon3.rada.gov.ua/laws/show/124-19
Technical regulation on medical devices, approved by Resolution of the Cabinet of Ministers of Ukraine №753 dated October 2, 2013
http://zakon2.rada.gov.ua/laws/show/753-2013-%D0%BF
Technical regulation on medical devices for in vitro diagnostic, approved by Resolution of the Cabinet of Ministers of Ukraine №754 dated October 2, 2013
http://zakon5.rada.gov.ua/laws/show/754-2013-%D0%BF
Technical regulation on active implantable medical devices, approved by Resolution of the Cabinet of Ministers of Ukraine №755 dated October 2, 2013
http://zakon5.rada.gov.ua/laws/show/755-2013-%D0%BF
Law of Ukraine "On the Principles of State Language Policy"
http://zakon3.rada.gov.ua/laws/show/5029-17
Law of Ukraine "On Protection of Consumer Rights"
http://zakon2.rada.gov.ua/laws/show/1023-12
Law of Ukraine "On accreditation of conformity assessment bodies"
http://zakon2.rada.gov.ua/laws/show/2407-14
Resolution of Cabinet of Ministers of Ukraine № 573 dated June 1, 2011 "On approval of the list of bodies of state market surveillance and their areas of responsibility"
http://zakon3.rada.gov.ua/laws/show/573-2011-%D0%BF
Resolution of Cabinet of Ministers of Ukraine №647 dated August 12, 2015 "On Approval of the Regulation on the State Administration of Ukraine on Medicines and Drugs Control"
http://zakon2.rada.gov.ua/laws/show/647-2015-%D0%BF
DSTU EN ISO/IEC 17021-1:2015 (EN ISO/IEC 17021-1:2015, IDT; ISO/IEC 17021-1:2015, IDT) Conformity assessment. Requirements for bodies providing audit and certification of management systems. Part 1. Requirements; related international normative documents: EN ISO/IEC 17021-1:2015, ISO/IEC 17021-1:2015
DSTU ISO/IEC TS 17021-2:2014 Conformity assessment. Requirements for bodies providing audit and certification of management systems. Part 2. Competence requirements for auditing and certification of environmental management systems (ІSO/ІEC TS 17021-2:2012, ІDT)
DSTU ISO/IEC 17021-3:2014 Conformity assessment. Requirements for bodies providing audit and certification of management systems. Part 3. Competence requirements for auditing and certification of quality management systems; related international normative documents: ISO/IEC 17021-3:2013
DSTU ISO/IEC 17025:2006 National Standard of Ukraine. General requirements for the competence of testing and calibration laboratories
http://www.certatom.kiev.ua/images/files/16.06.15_17025.pdf
Medical Device Directive MDD 93/42/EEC https://www.emergogroup.com/sites/default/files/file/europe-consolidated-mdd-93-42-eec.pdf?action
In Vitro Diagnostic Medical Devices Directive 98/79/EC
http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31998L0079
MEDDEV 2.5/10 "Guideline for Authorised representatives"
MEDDEV 2.12/1 rev.8 "Guidelines on a Medical Devices Vigilance System"
IAF MD 5:2015 Determination of Audit Time of Quality and Environmental Management Systems http://www.iaf.nu/upFiles/IAFMD5QMSEMSAuditDurationIssue311062015.pdf
IAF MD 9:2015 Application of ISO/IEC 17021 in the Field of Medical Device Quality Management Systems (ISO 13485) http://www.iaf.nu/upFiles/IAFMD9App17021MedicalDeviceQMSPublicationVersion.pdf