Today, the medical devices market rarely limits itself to a single country. Even if a company plans registration only in Russia, it is increasingly necessary to consider the requirements of the Eurasian Economic Union. This allows entering the markets of other Union countries without repeated procedures.
“It makes sense to focus on the EAEU if products are supplied not only within Russia but also to neighboring countries. However, registering a product according to Eurasian rules is difficult, time-consuming, and expensive. You need to obtain approval in at least two countries and pay duties for each. To supply products to all states, you have to declare them in each jurisdiction, and this is a labor-intensive process,” says Executive Director of “Equilibrium” Vladislav Klimov.
Currently, there are two registration systems: national — according to RF Government Decree No. 1684, and Eurasian — according to the College rules. Formally, you can choose either, but the differences are significant.
If you follow only Russian standards, registration will be faster and cheaper, but supplies will be limited to the territory of the Russian Federation.
“There are no risks, just a smaller market. By complying only with Russian requirements, the manufacturer will not violate the law, but will not be able to officially sell the product in other Union countries,” notes Vladislav Klimov. Registration according to EAEU rules opens up a wider market but requires time and serious expenses.
“The trust of partners does not depend on whether registration is conducted according to Russian or Eurasian rules. However, EAEU registration provides more opportunities: the market becomes wider, more clients appear, and there are more distribution directions,” adds Vladislav Klimov.
It is impossible to combine the two registration systems, as the dossier format, list of tests, and structure of examinations differ.
“Either we register a medical device according to the national system or according to EAEU rules. There is no universal way. We advise registering through the Russian procedure because the Eurasian one takes years and requires significant investments,” comments Vladislav Klimov.
It is worth noting that the approach of “Equilibrium” is based on choosing the most rational registration path without compromising quality.
"“Equilibrium” chooses the shortest registration method with optimal costs and without compromising quality. At the same time, we always recommend how to do it better. If a client is interested in the markets of other countries, for example, Kazakhstan or Kyrgyzstan, our recommendation is not to go through the EAEU but to register the product separately in each country according to the national system. This is faster, more reliable, and cheaper.
“Equilibrium” is always ready to provide full consultation and explain various registration methods. We do not take information from decrees or rules but only from experience. The company has come a long way and is ready to work with even the most complex projects," concluded Vladislav Klimov.
