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Registration of medical devices

Registration on the territory of the Russian Federation and abroad is mandatory for all medical devices entering the market

SUBMISSION OF AN APPLICATION FOR REGISTRATION:

IPS specialists determine the risk class, classification codes, discuss with the customer options for the design and implementation of the product, deliveries to medical institutions. And then they make up a competent application for registration.

You just give us the initial information, and we ensure the correct filing of documents, support and paperwork

IMPORTATION OF PRODUCTS INTO THE COUNTRY:

It is possible to introduce a foreign drug or product into the country for testing and further registration only with the special permission of Roszdravnadzor.

Experienced IPS experts will also help with this: we are familiar with all the requirements and nuances and will quickly prepare documents

TESTING:

We will select a laboratory for toxicological, technical, clinical and other types of product testing. And then we will conduct an examination of the test results so that they exactly meet the goals and requirements for your class and type of product.

Documentary proof of the quality and safety of the product is also our job

FORMATION OF A PACKAGE OF DOCUMENTS:

You do not need to delve into the requirements of Roszdravnadzor for the composition and execution of documents. Our experts will put together a package for the registration dossier and arrange everything without comments.

Correctly executed documents are a guarantee of quick registration

SUPPORT IN ROSZDRAVNADZOR:

Registration of a device of the 1st risk class takes from 6 to 8 months, the 2nd and 3rd risk classes - from 9 to 12 months. During the process, the registering authority may have questions, additional documentary requirements, and in case of illegal or controversial decisions, YOU may need a quick response and qualified assistance.

Therefore, IPS accompanies its clients until the moment of successful registration. We will be there and will take over communication with Roszdravnadzor experts

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