On this page, you can find official documents on the scope of accreditation of the Conformity Assessment Boy of the State Enterprise “L. I. Medvedev’s Research Centre of Preventive Toxicology, Food and Chemical Safety of the Ministry of Health of Ukraine” (ECOHYNTOX CAB).
Certificate of Accreditation in accordance with the requirements of ISO/IEC 17021:2011 in the following area:
- DSTU ISO 9001:2009 Quality management systems. Requirements (ISO 9001:2008, IDT);
- DSTU ISO 22000:2007 Food safety management systems. Requirements for any organizations in the food chain (ISO 22000:2005, IDT);
- DSTU ISO 13485:2005 Medical devices. Quality management systems. Requirements for regulatory purposes (ISO 13485:2003, IDT).
View the Appendix to the Certificate.
Certificate of Accreditation in accordance with the requirements of ISO/IEC 17065:2012 in the following scope:
- Technical Regulations on Medical Devices;
- Technical Regulations on Active Implantable Medical Devices;
- Technical Regulations on Medical Devices for In Vitro Diagnostics.
View the Appendix to the Certificate.
Information on Appointment of the State Enterprise “L. I. Medvedev’s Research Centre of Preventive Toxicology, Food and Chemical Safety of the Ministry of Health of Ukraine” as the Conformity Assessment Body for Assessment of Conformity to the Requirements of the Respective Technical Regulations (View the letter of the Ministry of Economic Development and Trade of Ukraine), namely:
- Technical Regulations on Medical Devices (View Order of the Ministry of Economic Development and Trade of Ukraine No. 1196 dated 21.07.2016);
- Technical Regulations on Active Implantable Medical Devices (View Order of the Ministry of Economic Development and Trade of Ukraine No. 1198 dated 21.07.2016);
- Technical Regulations on Medical Devices for In Vitro Diagnostics (View Order of the Ministry of Economic Development and Trade of Ukraine No. 1197 dated 21.07.2016).
