News Digest 20.06.2025 — 27.06.2025
Regulators
The government may ease the rules for purchasing medical equipment
The Ministry of Industry and Trade has developed amendments to the RF Government Resolution No. 1875 of 23.12.2024 "On measures to provide national treatment in the procurement of goods, works, services to meet state and municipal needs, procurement of goods, works, services by certain types of legal entities." The document is undergoing public discussion on the regulation.gov.ru portal until June 30.
The government established a scoring system for assessing the degree of localization of 18 types of medical equipment by Resolution No. 1293 of 08.08.2023. In particular, the list includes computed tomography scanners, mammographs, hardware and software systems for recording and processing X-ray images, as well as ultrasound machines.
At the same time, as stated in the explanatory note to the draft, for certain types of medical equipment, registry entries created before the introduction of the point system are still valid, based on certificates of origin of goods of form ST-1 and expert reports of the Chamber of Commerce and Industry of the Russian Federation. The validity periods of these registry entries will expire before the end of 2026.
The Ministry of Health will hold talks with Nicaragua on the registration of Russian drugs and medical devices
The Government of the Russian Federation approved an order according to which the Ministry of Health will hold talks to conclude a cooperation agreement with the National Authority for Sanitary Regulation of the Republic of Nicaragua.
The cooperation involves recognition (through the principle of trust) in Nicaragua of the registration of medicines and medical devices manufactured and registered in Russia. The decision to hold negotiations has been agreed upon with the Ministry of Foreign Affairs, the Ministry of Industry and Trade and the Ministry of Finance of the Russian Federation.
Source: https://t.me/vademecum_live/18281
Market news
EU to restrict Chinese medical device manufacturers' access to public procurement worth more than 5 million euros
The European Commission (EC) will restrict Chinese medical equipment manufacturers' access to public procurement in the EU countries worth more than 5 million euros. The measures taken will limit Chinese companies' access to approximately 59% of EU public spending on medical devices (about 150 billion euros). At the same time, the EC will allow companies not from China, but supplying products from there, to participate in procurement with a price above 5 million euros. In this case, the regulator will oblige the winners of tenders to supply goods of Chinese origin worth no more than 50% of the total price of the lot throughout the entire term of the contract. All this, the EC summarizes, can reduce imports of such products from China by 15-20% annually, which is from 1 billion to 1.2 billion euros per year out of a total volume of imports of Chinese products of 6.2 billion euros.
The Chinese authorities have promised to respond to restrictions on access to procurement of medical products in the EU
The Ministry of Commerce of China (MOFCOM) reported this on its account on the X social network. The statement emphasizes that the department's investigation, conducted in January 2025, indicates constant barriers from the European Union (EU) against Chinese enterprises in areas such as public procurement and investment. "The EU stubbornly continues to apply unilateral measures and create new protectionist barriers, despite China's sincerity, repeatedly demonstrated during bilateral negotiations," MOFCOM believes. Thematic decisions, according to the ministry, "seriously undermine the level playing field." China has promised to take retaliatory measures to "resolutely protect the legitimate rights and interests" of its companies.
Reuters writes that thematic initiatives maintain high trade tensions ahead of the summit, at which European leaders are to discuss economic relations with Chinese President Xi Jinping. The meeting is scheduled for July 2025. Earlier, the Financial Times reported that in June, the European side refused to hold another thematic meeting due to the lack of progress on numerous trade disputes.
On Friday, June 20, the European Commission restricted access for Chinese medical equipment manufacturers to EU public procurement worth more than 5 million euros. The reason for the restrictions was the commission's investigation into "direct and indirect discrimination" against medical products and suppliers from the European Union in the Chinese market. Vademecum's review covers how Chinese state programs to support domestic manufacturers became a reason for the EU to restrict the market for eastern companies.
Source: https://t.me/vademecum_live/18310
Other
Alibaba has introduced the world's first artificial intelligence (AI) model to detect stomach cancer at early stages
Alibaba Group Holding has introduced the world's first artificial intelligence (AI) model capable of detecting stomach cancer even at early stages by scanning computed tomography (CT) images, South China Morning Post reports.
AI algorithm Grape (the name comes from “gastric cancer risk assessment procedure”) can analyze 3-D CT scans to detect and segment stomach cancer. It was developed by Alibaba in collaboration with two Chinese public health organizations.
The neural network significantly outperformed radiologists, achieving a sensitivity of 85.1% and a specificity of 96.8%, according to a paper published in the journal Nature Medicine on Tuesday. Sensitivity measures the ability to detect disease, while specificity measures the ability to avoid false detection in healthy patients. It outperformed radiologists working without the model by 21.8% and 14%, respectively, especially for early-stage stomach cancer, the paper said.
The developers say the first-of-its-kind model “has the potential to change the approach to gastric cancer screening in China and even around the world,” and the rate of early-stage gastric cancer detection could “significantly increase.”
New registered medical devices
We publish a list of new medical devices registered from 06.20.2025 to 06.27.2025
Link to the list: [see table in the attachment]
News
