Control over the circulation of medical devices involves monitoring information about a whole range of parameters, starting with development and ending with disposal. This area includes compliance with licensing requirements for production and maintenance activities, the provision of relevant information by the subjects of treatment, and the quality, safety and effectiveness of medical devices.
Unlike medicines, monitoring the safety of medical devices takes into account the possibility of adverse events not only in patients, but also in medical personnel.
Such a variety of criteria requires manufacturers to constantly develop their competencies and raise awareness. At the same time, legal regulation does not stand still - new initiatives are emerging, the current norms are being finalized. For example, currently at the stage of summarizing the results of public discussion there is a draft Order "On amending the list of risk indicators for violations of mandatory requirements used by the Federal Service for Supervision of Healthcare in the implementation of federal State control (Supervision) over the circulation of medical devices dated July 17, 2023", which assumes an increase in risk indicators from four until five.
At the NOVAMED forum, a lot of attention is paid annually to the topic of control over the circulation of medical devices. So, in November last year, at an event within the framework of the Plenary Session, the head of Roszdravnadzor Alla Samoilova spoke about the state and prospects for the development of state control over the circulation of medical products in Russia according to national rules and the rules of the EAEU. It was noted that the agency is shifting the focus from strict supervisory actions towards preventive and preventive measures.
The experts of the session "Peculiarities of state control over the circulation of medical devices in the territory of the Russian Federation" will talk about what transformations have occurred recently and how they have affected the practical aspects of the activities of MI manufacturers. The session will be held in a round table format on November 15, from 13:30-14:30.
Participants will have the opportunity to familiarize themselves with the current requirements for conducting federal state control over the circulation of medical devices, statistics of major violations identified during the examination of quality, effectiveness and safety, criteria for conducting technical tests within the framework of state control.
An important part of the event will be the practical experience of conducting federal state control over the treatment of MI by the territorial bodies of Roszdravnadzor. The manufacturers' view of interaction with the supervisory authority during control and in the process of eliminating identified inconsistencies will allow them to analyze controversial issues and solutions based on specific cases.
An open discussion will allow you to identify key issues, exchange opinions, summarize ideas and conclusions. Manufacturers of medical devices, authorized representatives of manufacturers, as well as anyone interested in the topic of the round table are invited to participate.
The co-moderators will be Maria Migeeva, Deputy Head of the Department for the Organization of State Control and Registration of Medical Devices of the Federal Service for Healthcare Supervision, and Natalia Fomina, Deputy Director General of the Federal State Budgetary Institution VNIIIMT of Roszdravnadzor.
Place and time of the event:
15th of November
Moscow, Ramenskiy blvd., 1, Lomonosov Cluster
The "Molecule" hall
13:30-14:30
The organizers of the NOVAMED-2024 forum are the Federal Service for Supervision of Healthcare and the Federal State Budgetary Institution "VNIIIMT" of Roszdravnadzor, with the support of the Ministry of Health of the Russian Federation, the Ministry of Industry and Trade of the Russian Federation and the Federal State Budgetary Institution "Institute of Medical Materials" of the Ministry of Industry and Trade of the Russian Federation. The operator is the C–GROUP Corporate Communications Center.
Unlike medicines, monitoring the safety of medical devices takes into account the possibility of adverse events not only in patients, but also in medical personnel.
Such a variety of criteria requires manufacturers to constantly develop their competencies and raise awareness. At the same time, legal regulation does not stand still - new initiatives are emerging, the current norms are being finalized. For example, currently at the stage of summarizing the results of public discussion there is a draft Order "On amending the list of risk indicators for violations of mandatory requirements used by the Federal Service for Supervision of Healthcare in the implementation of federal State control (Supervision) over the circulation of medical devices dated July 17, 2023", which assumes an increase in risk indicators from four until five.
At the NOVAMED forum, a lot of attention is paid annually to the topic of control over the circulation of medical devices. So, in November last year, at an event within the framework of the Plenary Session, the head of Roszdravnadzor Alla Samoilova spoke about the state and prospects for the development of state control over the circulation of medical products in Russia according to national rules and the rules of the EAEU. It was noted that the agency is shifting the focus from strict supervisory actions towards preventive and preventive measures.
The experts of the session "Peculiarities of state control over the circulation of medical devices in the territory of the Russian Federation" will talk about what transformations have occurred recently and how they have affected the practical aspects of the activities of MI manufacturers. The session will be held in a round table format on November 15, from 13:30-14:30.
Participants will have the opportunity to familiarize themselves with the current requirements for conducting federal state control over the circulation of medical devices, statistics of major violations identified during the examination of quality, effectiveness and safety, criteria for conducting technical tests within the framework of state control.
An important part of the event will be the practical experience of conducting federal state control over the treatment of MI by the territorial bodies of Roszdravnadzor. The manufacturers' view of interaction with the supervisory authority during control and in the process of eliminating identified inconsistencies will allow them to analyze controversial issues and solutions based on specific cases.
An open discussion will allow you to identify key issues, exchange opinions, summarize ideas and conclusions. Manufacturers of medical devices, authorized representatives of manufacturers, as well as anyone interested in the topic of the round table are invited to participate.
The co-moderators will be Maria Migeeva, Deputy Head of the Department for the Organization of State Control and Registration of Medical Devices of the Federal Service for Healthcare Supervision, and Natalia Fomina, Deputy Director General of the Federal State Budgetary Institution VNIIIMT of Roszdravnadzor.
Place and time of the event:
15th of November
Moscow, Ramenskiy blvd., 1, Lomonosov Cluster
The "Molecule" hall
13:30-14:30
The organizers of the NOVAMED-2024 forum are the Federal Service for Supervision of Healthcare and the Federal State Budgetary Institution "VNIIIMT" of Roszdravnadzor, with the support of the Ministry of Health of the Russian Federation, the Ministry of Industry and Trade of the Russian Federation and the Federal State Budgetary Institution "Institute of Medical Materials" of the Ministry of Industry and Trade of the Russian Federation. The operator is the C–GROUP Corporate Communications Center.