The number of registrations of medical devices in the first half of 2023 decreased by 16.5%

The reduction in the activities of foreign suppliers of medical devices in Russia, such as 3M, Agilent and Illumina, negatively affects the range of the local market. According to the results of the first half of 2023, the number of medical device registrations decreased by 16.5% year-on-year, which was the worst result since the beginning of the pandemic. The emergence of medical devices from China and India on the market may be noticeable by the end of 2023, while Russian manufacturers still prefer to increase production volumes rather than expand the range, market participants note.

The number of registrations of medical devices in the first half of 2023 decreased by 16.5% year-on-year, to 1.13 thousand units, Kommersant calculated based on the register of Roszdravnadzor. This is the deepest drop in annual terms since the beginning of the COVID-19 pandemic, when the Russian government introduced a simplified registration of medical devices, including for increasing the production of respirators and tests. In the first half of 2020, the number of registrations increased by 2.9 times year-on-year, to 1.53 thousand units, and in the same periods of 2021–2022, the figure decreased by 3.7–8.4%.

The results of the first half of 2023 were affected by a decrease in the activity of foreign suppliers, say consultants for the introduction of medical devices to the Russian market of Medrelis and Meditex. Many Western manufacturers stopped projects until better times or abandoned them altogether, says Yuriy Matviyenko, general director of Medrelis. After the outbreak of hostilities in Ukraine, deliveries to the Russian Federation were stopped by the American manufacturer of respirators and dental products 3M, the supplier of laboratory, diagnostic equipment and reagents Thermo Fisher Scientific, the manufacturer of diagnostic equipment Agilent Technologies, the biotechnology company Illumina, etc. In the structure of registrations in the first half of 2023 foreign medical products accounted for 61.5% compared to 56% a year earlier.

The number of approvals issued by Roszdravnadzor for conducting clinical trials of medical devices in the first half of 2023 decreased even more significantly – by nine times, to 70 units. According to the CEO of Medleveltech, Mikhail Vinogradov, this is due to the simplification in 2022 of the rules for registering medical devices recognized as defective. Now, for the market launch of most of the names, except for the classes of high-risk medical devices, implantable and not having registered analogues, a separate permit for clinical trials is not required, he points out. But, Andrey Vilensky, the founder of NTC Meditex, notes, it was not possible to stimulate manufacturers to more actively withdraw medical devices in this way.

Aleksey Vanin, CEO of the consulting company MDPro, says that Russian distributors are now showing interest in products from China and India. But these are long deals, quick replacement of dropped out medical devices will not work, Yury Matvienko points out. Many companies are just starting to work with China and “stuffing bumps” on ignorance of the law or the peculiarities of contractual work, Mikhail Vinogradov confirms. According to Mr. Vanin, the registration of medical devices usually takes 1.5-2 years, and the work of applicants in 2021 and early 2022 is also reflected in the current indicators. According to him, the activity of Russian distributors regarding the registration of medical devices of Chinese companies probably began in the second half of 2022 and may be noticeable in the data of Roszdravnadzor by the end of 2023.

Andrei Vilensky notes that Russian manufacturers have become more active in the market, but import substitution occurs due to an increase in the output of already registered medical devices, and not through the launch of new items. According to him, there are also local companies entering this market, but not on such a scale that their activities would be noticeable on the growth of registrations. As Yury Matvienko notes, the Russian health care system as a whole can work at the expense of already registered medical devices, but the decrease in the number of registrations indicates a smaller entry of new, advanced Western technology to the market.

Polina Gritsenko