Localization of production

In the current macroeconomic and geopolitical environment, localization is becoming an integral factor in the development of all industries, including the medical device sector.

Given the state’s strategic focus on ensuring technological and industrial sovereignty, the topic of localization is becoming increasingly relevant.

Thus, the production and sale of medical devices are directly linked to compliance with localization criteria, which impacts both registration processes and market access.

On the one hand, this transforms approaches to organizing the production process, while on the other, the implementation of the state import substitution policy opens up new opportunities for Russian manufacturers and foreign companies that have localized their production in the Russian Federation.

Regulatory framework

On January 1, 2025, in accordance with Russian Government Resolution No. 1875, mandatory confirmation of the level of localization of medical device production came into effect.

While this requirement was previously advisory, possession of the CT-1 Certificate from the Russian Ministry of Industry and Trade is now mandatory for participation in government and commercial procurement.

We will perform the following work for you:

Assistance in selecting contract manufacturing for localization of medical devices production in the Russian Federation;

Assistance in determining the criteria for recognizing a product as domestic in accordance with Russian Government Resolution No. 719: the share of Russian components, the performance of key technological operations on the territory of the Russian Federation, compliance with documentary confirmation requirements;

Formation of a list of recommended suppliers of local components;

Drawing up a roadmap for all stages of localization, from the idea to inclusion in the register of domestic manufacturers, proactively identifying risks and requirements;

Assistance in importing components for assembly from other countries;

Development of documents;

Organization of tests and support at all stages of registration;

Organization of qualification tests of test samples;

Formation of a package of documents for submission to the Chamber of Commerce and Industry for the register of domestic manufacturers;

Formation of a package of documents for obtaining СT-1;

Necessary regulatory actions after replacement of raw materials and components.

Need a consultation?

Request a free consultation on the registration procedure  and ask all your questions.

Reasons to choose our team:

Professional approach

Our staff includes experts with proven experience in the field of medical device registration;

Individual approach

Individual solutions for complex and non-standard projects.

Coordination at all stages

When registering a domestic manufacturer, we draw attention to the need for coordination at all stages:

Putting into Production stages and processing documents in the correct chronological sequence,

Which information in the dossier should be paid attention to taking into account the audit of the Chamber of Commerce and Industry of the Russian Federation,

Which information should be included in the dossier, considering possible future changes in raw materials and components.

Professional approach

Our staff includes experts with proven experience in the field of medical device registration;

Individual approach

Individual solutions for complex and non-standard projects.

Coordination at all stages

When registering a domestic manufacturer, we draw attention to the need for coordination at all stages…More