Roszdravnadzor issued the first registration certificate for a medical device within the Eurasian Economic Union with a primary inspection of production

Roszdravnadzor issued the first registration certificate for a medical device within the Eurasian Economic Union with a primary inspection of production for compliance with the requirements for the implementation, maintenance and assessment of the quality management system for medical devices, depending on the potential risk of their use, approved by the Decision of the Council of the Eurasian Economic Commission of November 10 2017 No. 106.

The Federal Service for Surveillance in Healthcare informs about the issuance on September 16, 2020 of the first registration certificate within the framework of the Eurasian Economic Union for a medical device “A set of reagents for quantitative determination of total prostate-specific antigen by enzyme immunoassay (“DS-ELISA-PSA total”)” , produced by OOO NPO Diagnostic Systems with a primary inspection of production.

For the first time, during the registration of a medical device “A set of reagents for the quantitative determination of total prostate-specific antigen by enzyme-linked immunosorbent assay (“DS-IFA-PSA general”)”, the subordinate service of the Federal State Budgetary Institution “VNIIIMT” of Roszdravnadzor conducted a primary inspection of production for compliance with the requirements for and assessment of the quality management system of medical devices, depending on the potential risk of their use, approved by the Decision of the Council of the Eurasian Economic Commission of November 10, 2017 No. 106.

Based on the results of the assessment of the production conditions and the quality management system of the Russian manufacturer NPO Diagnostic Systems of the specified medical device, at two production sites located in the city of Nizhny Novgorod, the compliance of the quality management system of medical devices with the requirements for its implementation was established (including design processes and development).

The registered medical device is intended for the quantitative determination of total prostate-specific antigen (PSA) in human serum samples by the method of enzyme-linked immunosorbent assay (ELISA).

Additionally, we inform you that the state of recognition was the Republic of Kazakhstan.