Foreign manufacturers asked to postpone the introduction of labeling of new types of medical products: CT scanners, implantable stents, adult diapers. The company is especially concerned about the inclusion of heavy medical equipment in the experiment.
General Director of the Association of International Manufacturers of Medical Devices (IMEDA) Sergey Vanin asked the Ministry of Industry and Trade to consider manufacturers’ proposals for an additional six-month deferment of the requirement for mandatory labeling from March 2024 for CT scanners, implantable stents and diapers. Companies are focusing on the labor-intensive nature of the experiment for all participants in the supply chain, he said on November 8 on III All-Russian forum “Circle of medical devices “NOVAMED-2023”.
The format and location have not yet been determined marking on CT equipment (printed sticker or passport), there is no clear description of the experiment process and its stages, the expert said. “There is a question about the advisability of using this mechanism for this segment of medical products. So far, the purpose of the CT labeling program is not obvious to manufacturers and users,” says Vanin.
According to him, CT is a piece product that is produced for a specific customer, and the market volume of such products in Russia does not exceed 200-300 units per year.
Companies are also asked to coordinate industry participation in cross-departmental collaboration to assess the relevance of the experiment. To the operator systems for marking and tracking goods – LLC “Center for the Development of Advanced Technologies (CRPT) a checklist or “road map” should be developed and a labeling passport should be determined. At the same time, the specifics of the packaging of CT machines and the likelihood of its loss after installation must be taken into account, Vanin emphasized.
UPD! IN CRPT reported to MV that conscientious participants in the pilot, who did not sabotage the tests, successfully studied all the processes at the enterprises. A total of 249 companies took part in the experiment, including one tomograph manufacturer, GE Healthcare.
According to the CRPT, Vanin’s statements do not correspond to reality and contain incorrect value and emotional judgments.
“All processes have been fully tested, the stages are clear and contained in the developed regulatory documentation,” the CRPT believes. They emphasized that labeling of medical devices is being implemented in stages, and market participants have every opportunity to be fully prepared.
The pilot for labeling medical devices started in Russia on February 15, 2022 and assumed the voluntary participation of manufacturers. The project includes computed tomographs, hearing aids, coronary stents, air disinfectants, orthopedic shoes and absorbent underwear. From October 1, 2023, dietary supplements, antiseptics and wheelchairs are subject to mandatory labeling. From March 2024, this requirement is planned to be gradually extended to manufacturers of medical gloves.