News Digest 04.10.2024 — 11.10.2024
Regulators
The regulator will expand risk indicators for state control over the circulation of medical products
The Ministry of Health of the Russian Federation plans to expand the list of indicators of the risk of violation of mandatory requirements used by Roszdravnadzor in monitoring the circulation of medical devices. The Ministry has proposed to increase the number of reasons for verification from four to five.
The list of risk indicators is planned to include information about two or more deviations in the functioning of a medical device within six months when it is used in a clinic. Deviations that did not result in a threat to health and a threat to the lives of citizens will be counted.
The current criteria were established by the Ministry of Health in the summer of 2023. Among the risk markers are a twofold or more increase in the number of documents on the results of clinical trials of medical devices for a calendar year compared to the previous one, the receipt of an application for a license for MI maintenance (or amendments to the relevant documents) and others.
In November 2021, the Russian Government approved a new regulation on licensing the maintenance of medical devices. The document exempted the service of medical devices with a low risk class, as well as legal entities or individual entrepreneurs engaged in the maintenance of their own medical equipment.
Also, the new regulation exempts manufacturers or authorized persons of foreign manufacturers who are engaged in servicing equipment only of their brand from part of the licensing requirements, including the availability of a quality management system and a list of equipment and measuring instruments.
Market news
WHO has approved the first test for the diagnosis of smallpox in monkeys
The World Health Organization has approved for emergency use the first ever test for the detection of monkeypox (MPOX). The Alinity mpx Vasay product from Abbott Molecular Inc. is designed for in vitro disease diagnosis.
According to WHO, the use of the test "will be crucial to expand diagnostic capacity in countries where the need for rapid and accurate testing in connection with outbreaks has increased dramatically." Early diagnosis ensures timely treatment and care, as well as control over the spread of the virus.
Source: https://medvestnik.ru/content/news/VOZ-odobrila-pervyi-test-dlya-diagnostiki-ospy-obezyan.html
Other
Russia has developed a test system for the selection of targeted therapy for breast cancer
Scientists from Sechenov University and the OncoAtlas Center for Molecular Oncology have developed a high-tech genetic test of a new generation for patients with breast cancer. The first domestic test system makes it possible to identify mutations in genes that provoke the development of a hereditary disease, and at the same time determine sensitivity to targeted drugs to prescribe the most effective treatment, the press service of the university reported.
The new test system will be used by oncologists and specialists from clinical laboratories performing molecular genetic research. Its use will help improve the quality of medical care for patients by personalizing treatment.
In 2024, the Ministry of Health will launch a new federal incident related to the introduction of medical devices with artificial intelligence
By the end of the year, the Ministry of Health will launch another federal incident related to the introduction of medical devices with artificial intelligence (AI) into practical healthcare. As of today, 37 such products have already been registered, Deputy Minister of Health Vadim Vankov said at the plenary session of the conference "Information Technologies in Medicine", the correspondent of MV reports.
This year, each region should introduce at least three medical devices with AI. According to Vankov, 13 subjects have not yet been able to complete this task. He advised them to take a closer look at the Moscow platform with artificial intelligence services, which was opened to the regions this year. So far, only a few territories have taken advantage of this opportunity.
Source: https://medvestnik.ru/content/news/Minzdrav-zapustit-federalnyi-incident-po-medizdeliyam-s-II.html
New registered medical devices
We publish a list of new medical devices registered from 04.10.2024 to 11.10.2024
Link to the list: [see table in the attachment]
News
