Localization points for medical equipment to be accounted for with an 18-month delay
Russia`s Ministry of Industry and Trade is prepared to allow manufacturers of certain types of medical equipment to use old-style Russian localization documents alongside new ones until the end of 2026. This leniency will apply to ventilators, tomographs, X-ray machines, electrocardiographs, ultrasound therapy devices, and specific diagnostic apparatus. Experts suggest this could indicate a slower-than-expected pace for localizing production of this equipment in Russia, or the ministry`s desire to create a more predictable investment environment for companies.
The Ministry of Industry and Trade has developed a draft government resolution proposing to postpone the consideration of localization evaluation points for certain medical equipment types when granting state support until the end of 2026. The document is published on regulation.gov.ru. A similar decision was approved by the government a few days earlier for the procurement of certain categories of specialized clothing (Government Decree No. 901 of June 16, 2025).
As a reminder, in 2023, the government approved a point-based system to determine the country of origin for goods, including 18 types of medical equipment, to streamline support for domestic production. The stricter localization rules affected ventilators, CT scanners, mammography machines, X-ray equipment, sterilizers, ultrasound devices, and laboratory PCR equipment. Companies seeking state procurement preferences as domestic manufacturers now had to confirm the completion of a minimum volume of technological operations and research and development, as well as the use of Russian raw materials and components.
However, as the Ministry of Industry and Trade notes in the explanatory memorandum to the draft resolution, compliance for certain types of medical equipment is confirmed by registry entries created before the point system`s introduction, based on ST-1 certificates of origin issued according to assessments by the Chamber of Commerce and Industry. The validity of these certificates will expire by the end of 2026. As a result, the ministry clarifies, a situation has arisen where the numbers of valid registry entries are not accepted by customers under the «national regime» of procurement if the registry extracts do not indicate the sum of points, even though the entries themselves are current. Therefore, the ministry proposes to supplement point 10 of Resolution No. 1875 with a new subpoint «m» – regarding the removal of the requirement for mandatory indication of the sum of points for specific types of medical devices for which the point system was previously introduced. The list includes ventilators, tomographs, X-ray machines, and electrocardiographs, ultrasound therapy devices, and specific diagnostic apparatus. The new rule will be in effect until the end of 2026.
The Ministry`s press service reported that this removal applies *only* to the requirement to indicate point information in the extracts.
The draft resolution «does not affect the procedures for inclusion in the medical product registry or the operation of the point system regarding such products.» In practice, old and new domestic product registry entries will be applied equally, without considering the sum of points in the new ones.
Konstantin Zotov, CEO of MST.Group, notes that the Ministry of Industry and Trade`s proposal may indicate that the localization process for certain types of medical equipment is progressing slower than anticipated. «It`s impossible to quickly deploy full-scale production of complex equipment in Russia – there`s a lack of components, raw materials, and no one can instantly build the entire chain of component creation. Perhaps, understanding this, the ministry is ready to postpone the moment of tightening access to preferences, using formal grounds such as the existence of old registry entries,» he says.
According to Alexey Vanin, head of consulting company MDPro, other reasons could also be at play – the agency`s reluctance to put businesses in a situation of unpredictable rule changes. «At the same time, I don`t think the global course towards import substitution, which the Ministry of Industry and Trade supports, will change in any way. Everyone is focused on developing localization,» he says.
It should be noted that the total market volume for these types of medical equipment in Russia is approximately 130 billion rubles. Since 2022, due to difficulties with importing such equipment, its consumption in the domestic market has been declining. Its share in the overall market is approximately 7–10%.
