Service companies complain about excess imported medical equipment

Companies involved in servicing medical equipment have encountered difficulties in renewing licenses for their activities, which they need to do before January 1, 2024. The new rules adopted by the authorities require, in particular, to have foreign equipment, with which there are difficulties in supply and, moreover, often not used by market participants. Moreover, it will be risky to rent such equipment. Experts, on the contrary, believe that stricter requirements will contribute to the exit of unauthorized service companies from the market.

Kommersant has obtained letters from MedLevelTech (registration of medical devices) and Alkotektor (manufacturer of ethanol vapor analyzers in exhaled air) to State Duma Speaker Vyacheslav Volodin with a request to initiate changes to the new rules for re-issuing licenses for the maintenance of medical equipment, which will come into force on January 1, 2024. These conditions, the authors of the letters write, will complicate the process.

The State Duma staff reported that so far they have only received a letter from MedLevelTech and forwarded it to the Ministry of Health. They did not respond to Kommersant’s request.

The authors of the appeal indicate that the new rules force companies to purchase unnecessary, expensive equipment, which is “absolutely unacceptable in the current economic conditions.” For example, Alkotektor will now need, for example, a dynamometer, a tachometer, and an ultraviolet radiation radiometer, which the manufacturer of ethanol vapor analyzers in fact does not need. MedLevelTech proposes to provide an opportunity not to purchase unnecessary equipment. At the same time, on October 13, the Ministry of Health published a draft resolution exempting manufacturers from this if they only service their equipment in medical institutions. But Alkotektor proposes to issue licenses to manufacturers for the maintenance of certain types of medical products, so that it is possible to service equipment from third-party manufacturers.

In addition, notes General Director of MedLevelTech Mikhail Vinogradov, some types of required equipment are foreign-made and their supplies to the Russian Federation have been stopped, and their replacement with Russian analogues is not provided for by the new rules. He proposes to reconsider this provision. One of Kommersant’s interlocutors from among service companies confirms that many Western manufacturers of measuring instruments, for example Fluke Medical, left the Russian market amid the Russian military operations in Ukraine.

The government decree on the introduction of new rules for companies involved in servicing medical equipment from January 2024 was adopted back in November 2021 as part of the “road map” for the implementation of the “regulatory guillotine” mechanism aimed at reducing unnecessary pressure on business. But manufacturers and service companies are asking to soften the requirements now not only because of the difficulties that have arisen in the supply of Western equipment since 2022.

In August of this year, the Ministry of Health published a separate order, which identified the use of rented equipment that is used in another region of the country as a risk factor in the work of service companies. This may become a reason for Roszdravnadzor to refuse companies to re-issue a license, explains Mikhail Vinogradov. Previously, renting equipment for service organizations was a common practice, adds Alexey Vanin, CEO of the MDPro consulting company.

Mikhail Vinogradov insists that due to the new requirements, “many companies will lose their licenses” from January 1, 2024, and medical institutions will be left without equipment maintenance. At the same time, according to Kommersant’s source in the industry, the tightening of requirements for re-issuing licenses did not affect all segments. For example, according to him, to re-issue a license for the service of ophthalmological equipment, on the contrary, only two measuring instruments are required, although in practice much more are used.

Kommersant’s interlocutor considers the requirements for renewal of licenses to be justified and sees the positive side in the fact that unauthorized services will not receive a license and will leave the market. It is precisely such centers that are most likely to close, agrees Alexey Vanin. At the same time, the expert does not exclude that they may be in demand if the presence of Western manufacturers in Russia decreases.

Polina Gritsenko