News Digest 12.09.2025 — 19.09.2025
Regulators
Medical Glove Labeling Postponed Until March 2026
The government has once again postponed the start of the medical glove labeling experiment. According to Russian Government Resolution No. 1409 of September 12, 2025, "On Amending Russian Government Resolution No. 894 of May 31, 2023," market participants will be required to enter information about these medical devices into the product traceability system beginning March 1, 2026.
The deadline for mandatory labeling of medical gloves has already been postponed several times. Initially, the Ministry of Industry and Trade proposed adding identification to them beginning March 1, 2024. At the time, the ministry explained that market participants themselves had requested the inclusion of this type of medical device in the system. The high rate of counterfeit products in Russia and the prevalence of unscrupulous "repackagers" were cited as reasons for this.
"Medical device labeling is proceeding smoothly; glove labeling has been postponed until March 1, 2026. An experiment is currently underway," said Viktor Dmitriev, Director of the Association of Russian Pharmaceutical Manufacturers (ARPM), at the 18th "PROjections of the Future" conference. According to him, the main problem is the lack of a unified glossary, according to the Pharmaceutical Bulletin.
Source: https://medvestnik.ru/content/news/Markirovku-medicinskih-perchatok-otlojili-do-marta-2026-goda.html
Transition to a single medical device market will be delayed by two years
The Council of the Eurasian Economic Commission (EEC) proposed postponing the transition to uniform rules for medical devices in the countries of the Eurasian Economic Union (EAEU) by two years. The draft protocol was submitted for consideration to the EEC by Resolution No. 23 dated May 23, 2025.
Amendments are proposed to Article 11 of the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the EAEU dated December 23, 2014.
According to the amendments, applications for registration of a medical device under the old, national rules can be submitted until December 31, 2027 (currently until the end of 2025). Documents can be renewed (re-registered or amended) for medical devices already registered under national rules until December 31, 2028 (currently until the end of 2026).
The protocol will come into provisional application 10 days after it is signed by all parties.
The EEC Council also approved Resolution No. 25 dated August 1, 2025, which proposes amendments to the list of medical devices whose circulation is permitted without registration. It is proposed to add to the existing list cases involving the following categories of medical devices:
- unregistered medical devices for vital indications for a specific patient;
- medical devices intended for export;
- kits, first aid kits, and kits containing medical devices and medications (for use only within the country; the medications and medical devices inside must remain in their original consumer packaging).
Source: https://pharmvestnik.ru/content/news/Perehod-k-edinomu-rynku-medizdelii-otlojat-na-dva-goda.html
Market news
Medical device manufacturers are asking people to pay attention to the assortment of marketplaces
Russian medical devices are losing out to similar products imported from other countries without registration. This was reported by Igor Khasin, Director of Strategic Development Programs at Tonus JSC, speaking at the 18th "PROjections of the Future" conference.
"Despite the strict registration rules in the country, we see that the overwhelming majority of products on marketplace shelves have not undergone any registration and are being sold freely. Regulatory authorities are practically unresponsive: other than asking platforms to restrict the sale of such products, nothing is happening," he said. Syringes and blood transfusion systems, marketed as German and American products and imported into the country without registration certificates, can be found on online marketplaces, he added.
Despite the severe penalties provided for under Parts 1 and 2 of Article 238 of the Russian Criminal Code, Khasin stated that the system is not working. "Medical devices are sold with some kind of EurAsEC certificates, which supposedly replace registration certificates, or with letters guaranteeing registration certificates. The question arises: was this even possible?" he noted.
Domestic manufacturers are at a disadvantage: it takes them from one and a half to three years to bring any medical device to market. "But any trader, bringing a product from India or China, spends a few hours—they draw up a product card and that's it," the expert said.
He also lamented the bureaucratic nature of the medical device registration process and the amendment of its registration dossiers.
"The rules for registering medical devices and amending their registration dossiers have become disastrously complex, labor-intensive, and time-consuming. Because of this, almost all investment in the industry has been halted, and we cannot predict the timeframe for completing all the necessary testing and research."
Resolution No. 1684 of November 30, 2024, placed us in a situation where we are constantly updating our registration dossiers, even for medical devices we've been producing for decades. State standards and requirements are constantly changing, and research costs are rising," he explained.
Khasin proposed creating a working group under the auspices of the public council at Roszdravnadzor to address fast-track issues for registering medical devices and amending registration dossiers. "Furthermore, it's necessary to engage law enforcement agencies and the Ministry of Industry and Trade to bring order to online commerce," he added.
The issue of selling unregistered medical devices is a pressing issue, agreed Viktor Dmitriev, CEO of the Association of Russian Pharmaceutical Manufacturers (ARPM).
Other
VTsIOM: 19% of Russians believe microchipping will negatively impact human health
The VTsIOM analytical center surveyed 1,600 Russians over the age of 18 to determine their attitudes toward the implantation of microchips for medical and other purposes. Respondents cited the consequences for human life as one of the main drawbacks of microchipping technology. For example, 19% believe that implanting a foreign body will have a detrimental effect on a person's health and psyche, 4% believe that the chip may be rejected (incompatible with the body), and 2% of respondents believe microchipping poses a risk to life.
At the same time, 9% of Russians believe that microchipping will help sick people (for example, for health monitoring) and disabled people (4%).
Overall, the majority of respondents (85%) are familiar with the technology for implanting microchips into the human body. Additionally, 47% of respondents believe that the technical capability for microchipping already exists, but is not yet widely used. However, 66% of people, when assessing the likelihood of being microchipped, believe it is impossible.
Source: https://t.me/vademecum_live/19204
According to analytics company Precedence Research, the global market for portable medical devices will grow from $77.14 billion in 2025 to nearly $202.52 billion in 2034
The expected CAGR is 11.32%. Analysts attribute this growth to the popularity of home healthcare services, the rise in chronic diseases, and new developments in and investment in wearable health monitoring devices. These devices include glucometers, insulin pumps, portable ECG machines, pulse oximeters, and fitness trackers.
Chronic conditions such as diabetes and cardiovascular disease require constant monitoring, which has contributed to the increased demand for portable medical devices. In 2024, the global market for these mobile medical devices was valued at $69.3 billion, with the United States accounting for $23.2 billion. Analysts predict this figure will grow to $68.29 billion by 2034, with a growth rate of 11.4%.
A study by Precedence Research indicates that North America holds the largest share of the global market (39.39% by 2024), thanks to its advanced medical infrastructure, high adoption of digital health technologies, and government emphasis on preventative health. Established market players and high investment in research and development also play a significant role. Asia-Pacific is the fastest-growing region in the market, driven by increased healthcare awareness, an increasing number of patients with chronic diseases, and growing urban populations. Government initiatives aimed at digitalizing healthcare have also impacted the market size. Precedence Research: The portable medical device market will reach $202.52 billion by 2034
Source: https://t.me/vademecum_live/19253
Systems for diagnosing endometrial and bladder cancer have been developed in Novosibirsk
Maxim Filippenko, Head of the Pharmacokinetics Laboratory at the Institute of Chemical Biology and Fundamental Medicine (ICBFM) of the Siberian Branch of the Russian Academy of Sciences, spoke about the development of a reagent kit for the personalized diagnosis of these two types of cancer based on the analysis of the genetic profile of tumor cells. This makes it possible to detect mutations that affect sensitivity to certain drugs and develop individualized treatment regimens for patients. According to the developers, such reagent kits are unique in Russia.
If mutations or changes in specific genes are detected, the patient can be prescribed specific targeted therapy depending on the type of cancer, and a prognosis for the tumor's further development can also be provided. The diagnosis itself is performed using modified PCR methods at the DNA level for endometrial cancer and RNA and DNA analysis for bladder cancer.
According to Maxim Filippenko, the development of reagent kits has been completed, clinical trials have been conducted, and registration documents for Roszdravnadzor are currently being prepared.
Source: https://t.me/vademecum_live/19231
New registered medical devices
We publish a list of new medical devices registered from 09.12.2025 to 09.19.2025
Link to the list: [see table in the attachment]
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