FGBU «VNIIIMT» of Roszdravnadzor

History of FGBU «VNIIIMT» of Roszdravnadzor

Federal State Budget Institution «Russian Scientific and Research Institute for Medical Engineering» of Federal Service for Supervision in the sphere of public health

Founded in 1951 by the Decree of the USSR Council of Ministers signed by I. Stalin, the Federal State Budgetary Institution "Russian Scientific and Research Institute for Medical Engineering" of the Federal Service for Surveillance in Healthcare (the Institute) originated as the Scientific and Research Institute of Experimental Surgical Equipment and Instruments of the USSR Ministry of Health.

Since 2012, FSBI RSRIME has provided advice, analytics and expert support to Roszdravnadzor in charge of monitoring the safety of use of medical devices, in accordance with the government assignment. As part of the safety monitoring, FSBI RSRIME conducts analysis and expert evaluation of safety of use of medical devices throughout their life cycle, from import into the Russian Federation for registration purposes to post-marketing monitoring of their circulation in Russia. It also reviews open-source reports of decisions by foreign regulators, such as FDA (Food and Drug Administration, USA), MHRA (Medicines and Healthcare Products Regulatory Agency, UK) and Health Canada (Canada), regarding adverse events and develop guidelines and scientific and practical recommendations for monitoring the safety of use of medical devices.

Since 2018, the institute has been included in the list of healthcare institutions engaged in clinical trials of medical devices in vitro.

In 2018, following the audit that was run by the Technical Committee of IMQ S.p.A. (a European certification authority and a member of the international IQNet network), the quality management system of FSBI RSRIME of Roszdravnadzor was found compliant with the international standard ISO 9001:2015 (Certificate of Compliance with the following scope: examination of medical devices, technical trials and toxicological studies of medical devices).

In addition, since 2016, FSBI RSRIME of Roszdravnadzor has been authorized to negotiate on product certification for compliance with European directives. It is also a partner of the IMQ representative office in Russia and the CIS and is authorized to deal with applicants on issues of international certification of management systems under ISO 9001, ISO 14001, ISO 22000, OHSAS 18001, ISO 50001, ISO 27000, ISO 13485, GOST R 56404 (LEAN), GMP and IQNet SR 10.

Contacts

Fast-track

Current issues that manufacturers face when registering their medical devices and updating the registration dossier package:

• Long periods of time spent on the full-cycle registration of medical devices;
• Lack of capability to provide one-stop-shop services;
• Poor quality of registration dossier documents;
• High costs required to prepare the registration dossier since there is no access to all services in one place;
• Lack of understanding of the medical device registration stages and process;
• Lack of understanding of what is required to pass manufacturing inspection;
• High costs needed to develop the quality management system.

To address the aforementioned challenges faced by medical device manufacturers, FGBU «VNIIIMT» of Roszdravnadzor invites you to complete all stages of registration dossier preparation and inspection under the close supervision of professionals and experts in medical device registration using our fast-track.

Fast-track is a comprehensive service that may include the following sub-services:

• Finalization/development of technical/operational documents (hereinafter referred to as finalization/development);
• Advice on procedures related to registration and assessment of safety, quality and effectiveness of medical devices;
• Organization and completion of technical trials;
• Organization and completion of toxicological studies;
• Organization and completion of clinical in vitro diagnostics;
• Organization and completion of trials for the purpose of type approval of measuring instruments;
• Organization and support of clinical trials;
• Preliminary review and assessment of registration dossiers;
• Validation of sterilization processes;
• Clinical monitoring plan finalization/development;
• Support for electronic submission of applications and registration dossier documents through the applicant's unified user account on the federal governmental IT system Unified Portal of State and Municipal Services (Functions).

FOR TRANSLATION AND NOTARIZATION OF DOCUMENTATION FOR THE PURPOSES OF MEDICAL DEVICE REGISTRATION:

For foreign-made devices whose documentation is written in a foreign language, FGBU «VNIIIMT» of Roszdravnadzor offers professional translation and notarization services.

We process technical, medical and regulatory documents ensuring accurate and correct terminology.

We offer the following services:

• Written translation of documents from/into foreign languages
• Translation of registration and technical dossiers
• Translation of instructions, labels, certificates, reports, etc.
• Notarization of translated documents

We provide translations into the following languages:

• English
• Armenian
• Belarusian
• Italian
• Spanish
• Kazakh
• Kyrgyz
• Chinese
• German
• French
• Georgian
• Turkish
• Japanese
• Portuguese
• Arabic
• Thai

TO PREPARE FOR AN INSPECTION, WE OFFER THE FOLLOWING STEPS:

• Diagnostics of medical device production;
• Finalization/development of QMS documentation;
• Introduction of QMS documentation;
• Certification of QMS documentation conformance.

We also provide other services such as:

• Professional re-training;
• Professional development programs;
• Workshops;
• Custom-tailored education planning.

Application methods:

File your application online at test@vniiimt.ru

Send your application by mail at: 24 Kashirskoye Highway, bldg. 16, Moscow, Russia, 115478

https://t.me/vniiiimt

https://vk.com/vniiimt

Director General

Igor Vladimirovich Ivanov

+7 (495) 645-38-32

Novamed

The Forum will feature:

Multi-aspect program. Related to the medical device market, the program is intended for manufacturers, registrars, testing laboratories and healthcare institutions.

Up-to-date data. National standards and follow-up monitoring, quality and safety management, exports and procurement of medical devices.

Key regulators. Discussions, round tables and workshops by the Ministry of Health, Roszdravnadzor, Ministry of Industry and Trade, Ministry of Finance, Eurasian Economic Commission, Federal Antimonopoly Service and other relevant agencies.

Face-to-face conversation. An opportunity to discuss the most important issues related to the circulation of medical devices with experts and colleagues and to build new ties.