Mikhail Murashko advocated the introduction of mandatory labeling of medical devices
Russian Minister of Health Mikhail Murashko announced the introduction of mandatory labeling of medical devices. First of all, it should concern high-tech equipment and high-class medical devices of potential risk, the head of the Ministry of Health said. According to him, in order to combat counterfeit products, an information system will be created to identify each unit of a medical device.
“Mandatory labeling of all medicinal products was introduced on July 1, 2020, during a difficult pandemic period. At present, the system is operating normally, and virtually all drugs in civilian circulation pass through the labeling system. Each patient can independently check the legality of the purchased medicine through a mobile application. The next important step should be the introduction of mandatory labeling for medical devices, especially high-tech and those that have the greatest risks, ”said Mikhail Murashko at the IX International Forum“ Anti-Counterfeiting-2021 ”.
To track the labeling of medical devices, an information system will be created that will identify each unit of specialized products in circulation.
In January 2021, the Minister of Industry and Trade of the Russian Federation, Denis Manturov, reported that the issue of labeling medical devices – while in an experimental manner – is being worked out in the ministry. Among the possible nomenclature to be included in the experiment were coronary stents, diapers and CT scanners.
At the beginning of June 2021, an experiment on marking technical means of rehabilitation – mechanical and electric wheelchairs – was completed in Russia; its results were not publicly reported. In parallel, the Ministry of Industry and Trade announced an experiment on the labeling of coronary stents (code OKPD2 18.104.22.168), absorbent products used for incontinence (22.214.171.124), hearing aids (126.96.36.199), as well as orthopedic shoes and corrective inserts for them, including insoles and half insoles (codes 188.8.131.52-184.108.40.206). It is assumed that the experiment will last until February 28, 2023, participation in it for market players will be voluntary.
The operator of the marking system in both cases is the subsidiary structure of CRPT – LLC Operator-CRPT. A 25% share of the CRPT through Concern Avtomatika JSC belongs to Rostec State Corporation, 50% – to Peter-Service JSC, which is part of Alisher Usmanov’s USM Holdings, the remaining 25% – to Alexander Galitsky’s Elvis + Group LLC.
In parallel, Roszdravnadzor is building its own system for tracking the turnover of medical products. The agency is developing amendments to by-laws, in accordance with which it intends to oblige market participants – importers, distributors and manufacturers – to transfer to the automated information system of Roszdravnadzor data on all medical products imported or produced in the territory of the Russian Federation that have entered circulation. The data is needed by the department “for analysis in the framework of monitoring the safety of medical devices.”