Resolution N753 of CMU dd. 02.10.2013 “On approval of Technical regulation of medical devices”

Resolution N754 of CMU dd. 02.10.2013 “On approval of Technical regulation of medical devices for the diagnostics in vitro”

Resolution N755 of CMU dd. 02.10.2013 “On approval of Technical regulation concerning active medical products for the implantation”

Law of Ukraine № 124-VIII dd. 15.01.2015 “Оn Technical regulations and assessment of the conformity” 

 Guidance MEDDEVs

http://ec.europa.eu/health/medical-devices/documents/guidelines/index_en.htm

http://www.mhra.gov.uk/home/groups/dts-bs/documents/publication/con286965.pdf

 IAF Mandatory Documents (MD Series)

(http://www.iaf.nu/articles/Mandatory_Documents_/38)

 Regulatory document for authorized representatives

Resolution № 1497 of CMU dd. 09.11.2004 “On approval of the procedure of the state registration of the medical equipment and medical products”

(http://zakon2.rada.gov.ua/laws/show/1497-2004-п)

 Law of Ukraine “Оn confirmation of the conformity”

(http://zakon2.rada.gov.ua/laws/show/2406-14)

 Law of Ukraine “On the standards, technical regulations and the conformity assessment procedures”

(http://zakon1.rada.gov.ua/laws/show/3164-15)

Resolution № 1599 of CMU dd. 29.11.2001 “On approval of the description and rules of use of the national conformity mark”

(http://zakon2.rada.gov.ua/laws/show/1599-2001-п)

Resolution № 485 of CMU dd. 11.04.2002 “On approval of the Rules of the estimation of cost of the works concerning confirmation of compliance in the legislatively regulated field”

(http://zakon2.rada.gov.ua/laws/show/485-2002-п)

 Law of Ukraine “On metrology and metrological activities”

(http://zakon2.rada.gov.ua/laws/show/113/98-вр)

 Law of Ukraine “On accreditation of the conformity assessment authorities”

(http://zakon2.rada.gov.ua/laws/show/2407-14)

Law of Ukraine “On medicinal products”

(http://zakon1.rada.gov.ua/laws/show/123/96-вр)

 Law of Ukraine “On basic safety of the non-food products”

(http://zakon1.rada.gov.ua/laws/show/2736-17)

 Law of Ukraine “On the state market surveillance and the non-food products control”

(http://zakon2.rada.gov.ua/laws/show/2735-17)

 Law of Ukraine “On consumer rights protection»

(http://zakon1.rada.gov.ua/laws/show/1023-12)

 Resolution № 46-93 of the Cabinet of Ministers of Ukraine “On the standardization and certification” dd. 10.05.1993

(http://zakon2.rada.gov.ua/laws/show/46-93)

Resolution № 59 of CMU dd. 24.01.2007. “On approval of the procedure of the appointment of the bodies of assessment of the conformity of products, processes and services to the requirements of the technical regulations”

(http://zakon2.rada.gov.ua/laws/show/59-2007-п)

Resolution №446 of CMU dd. 14.05.2008 “On approval of the procedure of the custom clearance of products, imported to the customs territory of Ukraine, which are subject to the mandatory certification in Ukraine, and the acknowledgment of some resolutions of the Cabinet of Ministers of Ukraine as such, which have become invalid”

(http://zakon1.rada.gov.ua/laws/show/446-2008-п)