Registration on the territory of the Russian Federation and abroad is mandatory for all medical devices entering the market
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.
IPS will help you complete the mandatory registration procedure for medical devices for their release on the market in the Russian Federation.
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.
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.
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.