The Ministry of Industry and Trade admits the introduction of a ban on the state purchase of imported medical equipment in the presence of Russian counterparts

The Ministry of Industry and Trade of the Russian Federation is considering the possibility of introducing restrictions on government purchases of imported medical equipment in the event that domestic manufacturers with medical equipment competing in quality, functional characteristics and cost with foreign ones, by analogy with electronic products, are present on the Russian market. At the end of August 2021, the Government of the Russian Federation introduced the “second extra” rule in relation to a number of names of “heavy” medical equipment.
“Let’s see how the mechanism will work, because in parallel with the“ second extra ”mechanism, a ban was introduced on the purchase of imported radio-electronic products. If we understand that there are a number of manufacturers that can cover the demand, and there are real Russian analogues on the market, both in terms of quality and cost functional indicators, then, in principle, it will be possible to consider the option to close the market, making it only for Russian manufacturers „, – said the head of the department for the development of medical equipment and technologies of the Ministry of Industry and Trade of the Russian Federation Grigory Revazyan, adding that this decision will be agreed with the Ministry of Health of the Russian Federation.

The government of the Russian Federation introduced the “second extra” rule for 30 categories and 45 items of medical devices on August 31, 2021. It included gamma therapy devices, electrocardiographs, pulse oximeters and spirometers, otorhinoscopes, electroencephalographs, intraocular pressure monitors, ultrasound devices, microwave and ultrasound therapy, MRI, defibrillators, medical refrigerators and freezers, irradiators – recirculators, electrosurgical devices, sterilizers equipment, incubators for newborns, medical gas supply consoles and other equipment.

Medical devices are removed from the scope of the RF Government Decree No. 102 of February 5, 2015 and are included in the profile decree No. 878 of July 10, 2019 „On measures to stimulate the production of radio-electronic products.“ According to the amendments, for state purchases of products included in the list, if at least one supplier with the country of origin of the medical device from the EAEU enters the competition, all other applications with the offer of imported medical equipment will be rejected.

Soon after the government’s decision, the Ministry of Industry and Trade of the Russian Federation proposed to introduce a transitional period for the application of the „second extra“ rule: if the amendments are approved by December 31, 2022, for medical equipment as confirmation of production in the territory of the EAEU countries, in addition to information from the GISP register of the Ministry of Industry and Trade or the Eurasian register of industrial goods , the presence of the CT-1 certificate will be counted.