News Digest 16.08.2023 - 18.08.2023
Regulators
Vendors were exempted from part of the licensing requirements for the service of their medical equipment
The Russian government has approved amendments to the Regulations on licensing the service maintenance of medical equipment. In the new edition, manufacturers or authorized persons of foreign manufacturers who only service equipment of their own brand will be exempted from part of the licensing requirements, including the availability of a quality management system and a list of equipment and measuring instruments.
According to the amendments, the list of the concept of "maintenance" subject to licensing includes periodic scheduled and unscheduled maintenance, as well as repair and dismantling.
Manufacturers or authorized persons of foreign manufacturers who service their branded equipment and are listed in the registration certificate will be exempted from part of the licensing requirements, including the requirement of a quality management system and the availability of equipment and measuring instruments from the list.
In addition, the lists of equipment for the maintenance of medical devices of potential risk class 2a and 2b have been supplemented. They include cardiovascular medical devices, medical devices for obstetrics and gynecology, urological medical devices, radiological medical devices, including ultrasound scanners, magnetic resonance tomographs, products for plastic surgery, dermatology and cosmetology, ophthalmology, physiotherapy, as well as medical equipment for apheresis.
It will be possible to apply for a license, as well as make changes to it through the public services portal, and in terms of changing the name of work or services provided, Roszdravnadzor will not assess the company's compliance with license requirements.
The changes will come into effect on September 1, 2024.
For nutrient media, the localization scoring system is detailed
The Ministry of Industry and Trade has specified the criteria for the localization of nutrient media for growing microorganisms during the introduction of a scoring system. It is assumed that when determining the country of origin, the material and technical base, as well as the implementation of four technological operations in the country, will be taken into account. The minimum score threshold for recognizing medical devices as domestic will be set at 60 points.
Market news
FAS canceled the results of the Moscow offset for medical furniture for 5.1 billion rubles
The Commission of the Federal Antimonopoly Service (FAS) found violations in the offset contract for the localization of medical furniture in Moscow for a total of 5.1 billion rubles. According to the commission, the customer, represented by the Moscow Health Department (DZM), violated the Law on the contract system when generating the notice. The FAS ordered to return the applications submitted for the competition, bring the notice of the competition into the proper form and re-determine the winner. This is the second offset that causes complaints from regulators. Previously, antimonopoly officials considered it illegal to combine different types of medical devices in offset for the needs of the blood service, as a result of which the DZM was forced to cancel the tender.
Other
Ex-employees of the DZM received suspended sentences in the case of bid rigging in the supply of furniture
The Tushinsky District Court of the capital sentenced the former head of the logistics department of the Moscow Health Department (DZM) Alla Krupeychenko and the chief specialist of the department Lyudmila Salimgareeva to three years of suspended sentence and fines of 400 thousand rubles on charges of fraud in the supply of medical furniture to the capital's medical institutions . Bid rigging, according to the FAS, happened back in 2017, but it only came to a verdict on August 15, 2023. The verdict did not enter into force and was appealed to the court of appeal.
New registered medical devices
We publish a list of new medical devices registered from 08/11/2023 to 08/14/2023
https://asiamc.ru/uploads/blogs/2023-08-18/medregs_20230818.pdfNews
