This text has been translated using machine translation tools.
The current legislation of the Russian Federation provides for mandatory registration of medical equipment used in the country in various hospitals, centers, clinics and other institutions.
A document confirming the legal use of medical technology or related equipment is a registration certificate (RU), which has an unlimited validity period. This document is issued after Roszdravnadzor experts have checked the package of documents submitted by the applicant, carried out the necessary tests and tested the equipment.
It is very important to decide how the medical device will be registered, how you plan to import and sell it, how you are going to deliver it to health care facilities, do you want to participate in tenders? We help resolve these and many other issues in order to clearly determine the path we will take together
We determine the composition of the product, its accessories, the number of design options, and classification codes. A correctly drawn up application largely determines the success of further registration.
For foreign-made medical products, we prepare all the necessary documents to obtain import permission from Roszdravnadzor.
Each registration is unique in its own way. We help to correctly establish communication between the developer, manufacturer and production sites; We document the quality, effectiveness and safety of medical products. Properly selected documents are a reliable evidence base for any registration.
We know what Roszdravnadzor experts pay attention to, so we develop or adapt documentation for medical devices so that it passes the examination without any comments.
We have our own laboratory where they can conduct, qualitatively document and document the test results for your particular MI, with all its specifics and features. We monitor the testing process and also review the results to ensure they meet the registration goals.
Sometimes during the registration process of medical devices, controversial issues may arise that require qualified responses. For example, eliminating comments, or appealing against unlawful decisions of experts. We resolve these issues professionally, quickly and efficiently.
We have been registering medical devices since 2004. During this time, we became “hardened” by changes in the registration regulations and gained a lot of useful experience and knowledge.
