News Digest 05.09.2025 — 12.09.2025
Regulators
The validity period of national procedures for registration of medical devices is extended by 2 years
The EEC Council approved the draft Protocol extending the validity period of national procedures for registration of medical devices.
On May 23, 2025, the Council of the Eurasian Economic Commission adopted Resolution No. 23, which approved the draft Protocol on amendments to the Agreement on uniform principles and rules for circulation of medical devices.
The key changes introduced by the Protocol:
The validity period of national procedures for registration of medical devices is extended by 2 years.
Specifically, in Article 11 of the Agreement, the dates are changed as follows:
- "2025" is replaced by "2027".
- "2026" is replaced by "2028" (in two paragraphs).
This means that medical devices registered in the EAEU member states according to national rules will be able to circulate on the Union markets for much longer.
What's next?
- The draft Protocol has been sent to Member States to carry out the necessary domestic procedures (ratification).
- Members of the EAEU must inform the Commission of the progress of the procedures within 90 days from the date of entry into force of the Order.
- The Protocol will begin to be temporarily applied 10 days after its signing.
This is a critically important decision for all market participants - manufacturers, distributors and medical organizations. It allows avoiding a shortage of medical products and gives businesses additional time to transfer their products to the regulatory field of the EAEU.
This will not only allow market participants to prepare, but also legislators and regulators to improve the regulatory legal acts of the EAEU in the field of circulation of medical products.
Source: https://t.me/reg_devices/35102
The EEC Council clarified the rules for registration and examination of medical devices
The Council of the Eurasian Economic Commission (EEC) decided to amend the Rules for registration and examination of safety, quality and effectiveness of medical devices (approved by decision No. 46 of 12.02.2016). The new document - decision No. 50 of 08.07.2025 - was published at the end of August.
The main innovation concerns work with medical devices that are not yet included in the unified classifiers. Now the authorized body - the expert organization - is obliged to notify the applicant within 10 working days about the launch of the procedure for including a new type of product in the global nomenclature of medical devices (GMDN) and the nomenclature of medical devices of the Eurasian Economic Union (EAEU).
At the same time, it is indicated that a product can be included in the classifiers only if there are no comments on the registration dossier or after they are eliminated.
The document also introduces terminological clarifications. In particular, the phrase "adverse events and (or) accidents" is replaced by the wording "adverse events (incidents)", the term "processing" - by "processing".
The changes will come into force 180 days from the date of publication of the document - from February 24, 2026.
From January 1, 2022, Roszdravnadzor stopped accepting applications for registration of medical devices under national rules in connection with the transition to the regulation of the EAEU market. The transition to a single register was accompanied by serious concerns from the industry community, including due to the high cost of re-registration and the slow pace of examinations. Experts believe that a smooth transition to the registration of medical devices under the law of the EAEU by 2027 is not possible: the average speed of examination of a dossier by the Russian regulator is about 2000-3000 dossiers per year, and now there are several tens of thousands of entries in the register.
Glucometers, tonometers, endoprostheses and reagent kits will be included in the list of labeling
The Ministry of Industry and Trade proposed to extend the term of the experiment on labeling certain medical devices until August 31, 2026 (it is currently valid until February 28, 2026). The draft resolution is undergoing public discussion until September 24.
The amendments are proposed to be made to RF Government Resolution No. 620 of May 17, 2024. The experiment on labeling a number of medical devices began on September 1, 2024 and was supposed to last until August 31, 2025.
The draft also proposes to introduce specific stages of the experiment and set new deadlines for reporting for each stage. Thus, the methodological recommendations and schedule for the second stage must be submitted by October 31, 2025, and for the third stage - by February 28, 2026. The final report on the pilot results will be provided by August 1, 2026.
In addition, it was proposed to supplement the list of medical devices subject to labeling with new items and divide it into three stages:
- During the first stage (from September 1, 2024 to February 28, 2026), condoms, syringes, fillers, infusion systems, wipes, test tubes and medical masks, breathing equipment, incubators for newborns, implants for cosmetology and medical masks will be labeled.
- During the second stage (from October 1, 2025 to February 28, 2026): glucometers, glucose test strips, tonometers, express tests.
- During the third stage (from January 1, 2026 to August 31, 2026): reagent kits (in vitro), suture materials and endoprostheses.
The experiment operator is the Center for the Development of Advanced Technologies (CRPT). As previously reported by the head of the Pharma product group of the CRPT, Yegor Zhavoronkov, participation in the experiment for the industry will be voluntary and free of charge. The operator covers all expenses, so, according to him, there will be no increase in the final cost of these medical devices.
It was proposed to reduce the VAT rate on medicines and medical devices to 5%
Deputies proposed to reduce the value added tax (VAT) rate on certain categories of socially significant goods. Bill No. 1011590-8 on amendments to Article 164 of the second part of the Tax Code of the Russian Federation was submitted to the State Duma.
The authors of the document propose to reduce VAT on a number of goods from 10 to 5%. At the same time, if the inflation rate for a group of goods for the previous calendar year exceeds the inflation rate for all groups of goods, then the VAT rate for this group of goods in the next tax period will be zero.
One of such groups of goods in the document is medical goods of domestic and foreign production:
- Medicines, including pharmaceutical substances.
- Drugs intended for clinical trials.
- Drugs manufactured by pharmacy organizations.
- Medical devices (the exception will be those medical devices, the sale of which is already exempt from taxation).
The explanatory note to the document states that the previous increase in VAT from 18 to 20% did not live up to the promises to finance national projects, and additional revenues were directed to those areas that, even without this increase in income, are the most profitable and have the highest wages in the country.
The document is aimed primarily at supporting the least well-off families, whose share of expenses on food products is more than 40% of the total expenditure.
If approved, the document will come into force on January 1, 2026.
Market news
Production of laboratory analyzers in Russia increased by 10% in a year
The production of laboratory analyzers in Russia in 2024 increased by 10% and reached 3.64 thousand units. This is a record figure since 2000, the BusinesStat agency reported.
Since 2020, the production of laboratory analyzers in the country has increased by 52%. Among the factors that stimulated the growth of production, analysts cite the consequences of the COVID-19 pandemic and Western sanctions, which forced a number of foreign manufacturers of medical equipment to leave the Russian market. This served as an incentive for the development of domestic production of laboratory analyzers.
In addition, the industry received a wide range of support measures, including tax breaks and subsidies. The procedures for registering medical equipment were also simplified.
Domestic manufacturers of laboratory analyzers offer innovative solutions that meet the requirements of modern laboratories.
Medical industry enterprises annually expand the range of manufactured devices and launch new production lines.
Leading manufacturers of laboratory analyzers in Russia include the following companies: DNA-Technology, Factor-Med Production, Alkor Bio, Diksion, and JSC Diakon-DS. They provide a significant portion of domestic production.
Other
Ultrasound "helmet" for non-invasive treatment of Parkinson's disease developed in the UK
Scientists from interdisciplinary teams from University College London and Oxford University have created a device integrated with MRI using ultrasound to more accurately deliver electrical impulses to the brain, based on a transcranial ultrasound system. The new helmet-shaped device can act as an alternative to deep brain stimulation (DBS) and help in the treatment of Parkinson's disease, depression, Tourette syndrome, chronic pain, and Alzheimer's disease.
The device's special feature is its non-invasiveness, which is how it differs from deep brain stimulation, in which electrodes are implanted deep into the patient's brain to deliver electrical impulses.
The work lasted more than ten years. The first trial involved seven volunteers, with ultrasound waves directed to an area of the brain the size of a grain of rice - the lateral pulvinar nucleus of the thalamus, where visual information is sent to the cerebral cortex. According to senior author of the study, Professor Charlotte Stagg from the University of Oxford, the waves hit their target with amazing accuracy. She noted that no one had done this before.
Subsequent tests showed that the new technology causes long-term effects in the visual cortex, reducing its activity. According to Stagg, in patients with Parkinson's disease, when sending impulses to the motor control area, you can see how the tremor disappears.
Independent expert and professor of neurology Elsa Furanian from the University of Plymouth believes that the development represents a fundamental milestone in the field of neurology. The team of scientists plans to conduct further testing of the device for the treatment of Parkinson's disease, schizophrenia and other diseases, as well as for recovery from stroke.
Source: https://t.me/vademecum_live/19094
New registered medical devices
We publish a list of new medical devices registered from 09.05.2025 to 09.12.2025
Link to the list: [see table in the attachment]
News
