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NOVAMED 2024: The session "Features of registration of medical devices" will be held on November 14

Registration of medical devices is a multi–stage mechanism that requires careful attention from industry participants at all stages, as well as knowledge of the intricacies of procedures and the latest changes in regulatory regulation. The current request of the industry is to receive up-to-date reliable information and conduct an open dialogue between government organizations and institutes, laboratories and testing centers, manufacturers.

The session "Peculiarities of registration of medical devices", which will be held at the Novamed 2024 forum, on November 14, will help to better understand the current state of affairs and assess the prospects for the development of law enforcement practices. The participants will discuss the latest changes in legislation and receive answers to their questions.

· The session will present an overview of the current procedures for the state registration of medical devices in the territory of the Russian Federation.

· Specialists of the Federal State Budgetary Institution "VNIIIMT" of Roszdravnadzor will analyze typical errors in sets of documents for registration of medical devices identified during the examination, as well as tell about the analysis of test results during the examination of effectiveness, quality and safety.

· A separate block of questions will be devoted to the preparation of a program of clinical and laboratory tests of a medical device based on statistics.

· A workshop in the "question/answer" format will help you navigate the procedures for making changes to the registration dossier.

The experts of the event will be representatives of the Ministry of Health of Russia, Roszdravnadzor, Federal State Budgetary Institution "National Institute of Quality" Roszdravnadzor, Federal State Budgetary Institution "VNIIIMT" Roszdravnadzor.

Manufacturers of medical devices, authorized representatives of manufacturers, distributors, service center specialists, as well as anyone interested in the topics of the reports are invited to participate.

Place and time of the event:

Moscow, Ramenskiy blvd., 1, Lomonosov Cluster

The "Molecule" hall

13:30 – 15:30

The Novamed 2024 Forum will be held from November 14th to 15th.

The organizers 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.