Supervision of the medical devices circulation
Consultation, analysis, audit and development of measures to eliminate violations
Operation Steps
Analysis of the relevance of documentation, consulting MD manufacturers on the control of the circulation of medical devices (preparation for state control)
The analysis and consultation is carried out within the requirements of Federal Law No. 323-FZ of November 21, 2011 “On Basics of Health Protection of Citizens in the Russian Federation”, Federal Law No. 184-FZ of December 27, 2002 “On Technical Regulation”, Resolution of the Government of the Russian Federation No. 1416 of December 27, 2012 “On Approval of the Rules for State Registration of Medical Devices”, Order No. 10449 of Roszdravnadzor of December 20, 2017 “On Approval of Forms of Check Lists Used by the Federal Service for Surveillance in Healthcare and Its Regional Offices When Conducting Routine Inspections During State Control Over the Circulation of Medical Devices”.
Assessment of the need for the Introduction of amendments to the marketing authorization file, Intro of amendments to the marketing authorization, audit of manufacturers for compliance with the legal requirements on quality control of medical devices
We determine the scope and timing of the Introduction of amendments to the marketing authorization file, prepare the optimal schemes of the procedure.
Report on the need for Introduction of amendments to the marketing authorization file and to the marketing authorization, action plan for bringing MD production to conformity
We help the manufacturer prepare for the examination for compliance with the legal requirements in the field of quality control of medical devices, working out the necessary measures. An individual approach to everyone!