Medical Registration

MEDICAL DEVICE REGISTRATION IN RUSSIA

In accordance with article 38 of the federal law of 21.11.2011 N 323-FZ, dedicated to the protection of the health of citizens, only those medical products that have passed the state registration procedure in accordance with the established procedure are allowed for free sale in Russia. The fact of its passage is confirmed by the issuance of a special document – a registration certificate. The requirement for its availability applies to all types of medical products that are available for free sale.

However, if the product is intended for individual use by a specific patient and is made specifically for him by private order, taking into account the instructions of the attending physician, it is not necessary to register such a product.

The procedure for state registration is determined by the provisions of Government Decree No. 1416 of December 27, 2012. This regulatory act indicates that Roszdravnadzor is responsible for state registration of medical goods. In this situation, the applicant will need to confirm the quality, efficacy and safety of his product, at his own expense organizing and conducting a number of important studies.

What Our Clients Say

It was a pleasure working with a company like GOST-Expert. From beginning to end they were available to answer all questions and made the process of Russian certification easy and cost effective
Our company was in need of certifications for our equipment for a project we wanted to implement in Russia. GOST-Expert was recommended to us by a colleague that had dealt with them in the past for his project. All the personnel at GOST-Expert was quick to answer our inquiries and our company obtained certification within a few weeks
We had a large project in Russia and after comparing estimates from other certification companies in the market, we realized that GOST-Expert was our best choice. Not only were they extremely professional to deal with but they also offered the best rates of any other company. I would recommend them without hesitation.
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