Large foreign companies are having difficulty obtaining licenses to service medical devices under the new rules

Large foreign companies are having difficulty obtaining licenses to service medical devices under the new rules that came into force on January 1, 2024. These include representatives of Medtronic, Becton Dickinson, Draeger and Fujifilm, which supply ventilators, X-ray equipment and blood glucose monitoring systems. Companies are working to obtain licenses. But experts warn of serious difficulties in meeting some of the new requirements.

Russian representative offices of the American Medtronic and Becton Dickinson, the German Draeger, and the Japanese Fujifilm have lost their licenses for the maintenance of medical devices since January 1, 2024, Kommersant discovered in Roszdravnadzor documents. This is due to changes in licensing rules for companies involved in servicing medical devices, which came into force this year. Now market participants are required to have a full list of measuring equipment in accordance with the product group, have a certain number of engineers on staff, and implement a quality management system according to a certain standard.

The range of these companies includes coronary stents, ventilators, X-ray systems, glucose monitoring, etc. 38 structures of the CS Medica group, which supplies blood pressure monitors and other medical equipment from the Japanese Omron to the Russian Federation, and several enterprises of the Delrus group also lost their licenses. In total, according to Roszdravnadzor, the licenses of 2.58 thousand companies were terminated, while 1.78 thousand companies retained their permits.

The Russian offices of Draeger and Medtronic told Kommersant that they are working to obtain new licenses for maintenance and repair. According to Andrey Berdikhin, director of the service center of Draeger LLC, the company “has taken measures to ensure that the period of paperwork does not affect customer support.” The representative offices of Becton Dickinson and Fujifilm, CS Medica and Delrus did not answer Kommersant’s questions.

Roszdravnadzor told Kommersant that changes in the field of maintenance of medical devices were made within the framework of the “regulatory guillotine” mechanism. For example, the service points out, service companies no longer need to obtain a license to service the entire range of medical equipment if permission to service one or two types of simple products or medical furniture is required. They added that most of the organizations actually working in this area renewed their licenses on time, and the departure from the market of companies that did not renew their licenses “will not affect the quality and timeliness of maintenance and repair of medical equipment.” According to Roszdravnadzor estimates, a total of 2–2.5 thousand companies are engaged in servicing medical devices; 200 organizations have submitted applications and will receive licenses “in the near future.”

Market participants warned in a letter to State Duma Speaker Vyacheslav Volodin that companies involved in the repair and maintenance of medical devices have difficulties re-issuing licenses (see “Kommersant” dated October 20, 2023). As stated in the appeal and Kommersant’s interlocutors, some of the equipment necessary for licensing is no longer supplied to the Russian Federation.

Natalya Lebedeva, head of the legal department of the service company MEDEQI, says that the main difficulties for a license applicant are created by the requirements for quality management to meet certain standards, the availability of expensive tools and measuring equipment. General Director of Medleveltech (in charge of registering medical devices) Mikhail Vinogradov says that for large players with all the resources, obtaining a license should not take much time, but delays may occur due to a sharply increased load on the Roszdravnadzor apparatus. But small market participants, he adds, may not be able to meet the new requirements.

A complete suspension of servicing of equipment from large foreign manufacturers is unlikely to be expected, says Andrey Vilensky, general director of the analytical company Meditex. According to him, repair engineers remain in the clinics themselves, where this equipment is available, and the manufacturers themselves can, before obtaining licenses, conduct some maintenance activities that are not obviously subject to supervision.

Polina Gritsenko