New Requirements for the Localisation of Medical Devices and Pharmaceutical Products

On 1 July 2026, amendments to Resolution of the Government of the Russian Federation No. 719 of 17 July 2015 “On the Certification of the Manufacture of Russian Industrial Products” (hereinafter “Resolution No. 719”) came into force.

The amendments were introduced by two legislative acts:

• Decree of the Government of the Russian Federation No. 1392 of 10 September 2025 “On Amending Decree of the Government of the Russian Federation No. 719 of 17 July 2015” – in respect of pharmaceutical products;

• clauses 1 and 7 of Resolution of the Government of the Russian Federation No. 351 of 31 March 2026 “On Amending Resolution of the Government of the Russian Federation No. 719 of 17 July 2015” – in respect of medical products.

The new version will set out the requirements specified in the annex to Resolution No. 719, including those relating to certain medical and pharmaceutical products.

1. Medical Industry

New Items in Section VII

Requirements are introduced regarding the localisation of new medical products, which were previously absent from Resolution No. 719. Thus, section VII has been supplemented with several items. This primarily concerns prosthetic and orthopaedic devices and technical rehabilitation aids.

Such products of the medical industry may be classified as Russian industrial products provided that the following total number of points is achieved for each unit of production. Specific examples are given below (the full list includes over than 20 items):

For what points are awarded?

Points are awarded, firstly, for the use of components, raw materials and other materials produced within the territories of EAEU member states, and, secondly, for carrying out production and technological operations within those territories. For example, in the production of a hydraulically controlled knee module, points are awarded for the following operations:

In addition to the scoring requirements, there are “entry” conditions, failure to meet which excludes the product from being classified as Russian regardless of the points scored, for example:

• the industrial operator – a tax resident of an EAEU member state – must hold valid rights to the technical documentation for the manufacture of the relevant products, with a total validity period of at least 5 years;

• the preparation of design and manufacturing documentation in accordance with the requirements of the unified systems;

• for test strips – additionally, the existence of a document confirming that the entity’s own production complies with GOST ISO 13485-2017 or the international standard ISO 13485, etc.

2. Pharmaceutical products

Section VIII of the Annex to Decree No. 719 includes two items:

• “Medicinal products, serums and vaccines”;

• “Pharmaceutical substances”.

According to the new Note 63, pharmaceutical products may be classified as Russian industrial products provided that a score of at least 50 points is achieved for the implementation, within the territories of the EAEU member states, of the technological processes specified in Section VIII for each unit of production.

Points are awarded as follows:

A mandatory requirement for medicinal products is their registration in accordance with the established procedure under the legislation of the Russian Federation and/or the EAEU, while for active pharmaceutical ingredients, information about them must be included in the state register of medicinal products or in the unified EAEU register of registered medicinal products.

Thus, a threshold of 50 points is sufficient for a product to be considered Russian; this can be achieved either through the manufacture of the finished medicinal product within the EAEU or through the manufacture of the active pharmaceutical ingredient within the EAEU. The full cycle (active pharmaceutical ingredient and finished medicinal product) yields 100 points.

3. Significance of the Changes

The amendments continue the trend towards deepening the localisation of industry in the Russian Federation. For the medical industry, the points-based requirements have been extended in detail to cover a range of prosthetic and orthopaedic devices and technical rehabilitation aids.

The practical significance of compliance with the requirements of the annex to Decree No. 719 lies in the inclusion of information in the Register of Russian Industrial Products and, consequently, access to preferential treatment for certain goods, such as medicinal products, in public procurement.

Lidings supports localisation projects across various industrial sectors: from concluding contracts with foreign partners and technology transfer to obtaining documents confirming the status of a locally produced product. With regard to medicinal products, we assist with participation in public procurement and obtaining preferential treatment.