Wheelchair labeling will become mandatory from 1 February 2023
From February 1, 2023, the Ministry of Industry and Trade of the Russian Federation will introduce mandatory labeling of wheelchairs related to medical devices. The measure will affect both the means of rehabilitation produced in the Russian Federation and imported from abroad. The voluntary labeling experiment took place from June 2019 to June 2021, its results were not reported.
It is assumed that manufacturers and importers will be required to label medical devices and enter information into the state information monitoring system. Medical products already imported into the Russian Federation and not in circulation will have to receive marking before May 1, 2023, and those purchased before February 1, 2023 and released by the customs authorities after the deadline – until March 15, 2023.
For labeling, the system will be used, which was previously used during the experiment on voluntary labeling – it is assumed that market players who took part in the pilot project will be automatically registered in the system.
The experiment on voluntary labeling of wheelchairs took place from June 1, 2019 to June 1, 2021. The pilot project was carried out to counter the “illegal manufacture and circulation of wheelchairs”. The operator of the system was Operator-CRPT.
In January 2021, the Minister of Industry and Trade of the Russian Federation, Denis Manturov, reported that the issue of labeling medical devices – so far 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 computed tomography scanners.
In November 2021, the Ministry of Industry and Trade of the Russian Federation announced an experiment on the labeling of radio-electronic products, including medical products. It is assumed that the pilot project will include computer and magnetic resonance tomographs, X-ray equipment, hearing aids, ultrasound scanners and other medical devices. The experiment starts on January 1, 2022 and will last until September 1, 2022; participation in it for market players will be voluntary.
Russian Minister of Health Mikhail Murashko supported the introduction of mandatory labeling of medical devices. First of all, it should concern high-tech equipment and high-end medical devices of potential risk, he said in August 2021.