Cost of medical device registration service


The Engineering Center Medical Devices and Technics provides consulting services in the field of registration of medical devices and medical equipment. The cost of services depends on the terms of execution. It also consists of a combination of factors such as the amount of documentation that requires revision and the complexity of the registered product. Tests are carried out only in accredited laboratories.

Engineering Center Medical Products and Equipment

Initial consultation with the specialists is free of charge. Please note that you are immediately communicating with an expert, and not with a sales manager. As part of the initial consultation, they inform you in detail about the regulations for conducting registration actions and the mandatory requirements for medical devices. They will advise on possible organizational and technological solutions. Engineering Center Medical Devices and Technics specialists have extensive experience. They can assist at any stage, including services for finalizing the registration dossier materials for notifying ic mit сайт about a non-benign medical device and lifting the ban on its sale.

The state duty for the issuance of a registration certificate in the EAEU is fixed at 7 thousand rubles. The state duty to examine the safety, quality, and effectiveness of a medical device is determined by the risk class to which a particular device belongs. It is 45 thousand rubles for class 1 products; 65 thousand rubles for class 2a products; 85 thousand rubles for class 2b products; 115 thousand rubles for class 3 products.

Engineering Center Medical Products and Equipment

The state fee for the approval of an expert opinion on assessing the safety, effectiveness, and quality of a medical device during its registration is determined by the risk class to which the specific product belongs. It is 45 thousand rubles for class 1 products; 65 thousand rubles for class 2a products; 85 thousand rubles for class 2b products; 115 thousand rubles for class 3 products. The final examination's initial price depends on the class assigned to the product, which indicates the risk it carries to potential buyers. The minimum price for such a service is 80 thousand rubles.