circulation of medical devices 1 Starting from January 1 st 2013 - PowerPoint PPT Presentation

MINISTRY OF HEALTH ROSZDRAVNADZOR Administration in the sphere of circulation of medical devices 1

Starting from January 1 st 2013 In accordance with Art. 38 / Federal law № 323: State registration of medical devices Pre-market approval Issuance of import permits for medical devices and post-market for the purpose of state registration surveillance of medical devices Control over the entire life cycle of medical devices Monitoring of safety of medical devices Licensing the manufacturing of medical devices

Regulation of the Circulation of MD In accordance with the Federal law «On the fundamental principles of healthcare in the Russian Federation» RESOLUTIONS OF THE GOVERNMENT OF THE RUSSIAN FEDERATION 3

The scheme of registration ( I level) Ro Checking the Ministry of Health Package of Roszdravnadzor APPLICANT documents (documents for the state registration A negative A positive of MD) conclusion - conclusion - the refusal the direction of state to clinical registration trials of the MD Technical and toxicological tests (Independent laboratory) Conclusion of determine the possibility expert (impossibility) of clinical trials organization Expert organization 4

The scheme of registration of MD ( 2 level) Ministry of Health Renewal of Roszdravnadzor state Applicant A positive registration (clinical conclusion - a trial ) decision on the state A negative conclusion - the registration refusal of state registration of the MD examination of the completeness Conclusion from and the results of technical tests expert and clinical studies organization Expert organization 5