Free consultations (products intended to be used for coronavirus infection diagnostics)
Since March 20, 2020, due to the need to take measures for the non-proliferation of the Coronavirus infection (2019-nCoV), the Federal Service for Surveillance in the Sphere of Health of the Russian Federation (Roszdravnadzor or RZN) introduces special rules. These rules concern consultations about the registration of medical devices intended for the diagnosis of coronavirus infection (consultations in accordance with the Order of the Federal Service for Supervision in Healthcare dated July 19, 2017 No. 6478 “On approval of the Procedure for implementation of the consultations related to the state registration of medical devices by the Federal State Budgetary Institution” All-Russian Scientific Research and Testing Institute of Medical Technology “of the Federal Service for Supervision of Healthcare and the Federal State Budgetary institution “Center for Monitoring and Clinical and Economic Expertise” of the Federal Service for the Supervision of Health “.
According to the changes introduced, developers, manufacturers of a medical device or authorized representatives of manufacturers can receive consultations on the following issues free of charge:
– development of a medical device and related documents,
– the procedure for conducting tests (studies) required for the state registration of a medical device,
– development of documentation for amending the documents contained in the registration dossier for a medical device,
– the procedure for conducting tests (studies) necessary to amend the registration certificate for a medical device;
– development of the amendments to the registration certificate;
– the procedure for conducting tests (studies) necessary to amend the documents contained in the registration dossier for a medical device;
– attribution of the product to the medical devices;
– classification of medical devices in accordance with the Nomenclature classification of medical devices under Order 4n.
Consulting carried out by means of contacting one of the expert centers:
Federal State Budgetary Institution “All-Russian Scientific Research and Testing Institute of Medical Technology” of Roszdravnadzor and Federal State Budgetary Institution “NATIONAL INSTITUTE OF QUALITY”.
You can leave a request for remote consultations online at the VNIIMT website https://www.vniiimt.ru/konsultatsii/index.php
FSBI “NATIONAL INSTITUTE OF QUALITY” http://www.cmkee.ru/activities/consultation-regmed/