Roszdravnadzor is considering the possibility of opening data on the introduction of medical products into circulation fro public access. It is planned to do this through the creation of a public system in which market participants will be able to verify the legality of the introduction of the products in circulation by checking the registration and serial number of the medical device, Vademecum reports.
Dmitry Pavlyukov, Deputy Head of Roszdravnadzor, talked about that at the XIV All-Russian Congress of Employees of Pharmaceutical and Medical Industry enterprises. According to him, the agency is considering several possible ways to motivate manufacturers and authorized representatives of foreign companies to enter data into the medical devices monitoring system. The first administrative liability under Article 6.28 of the Administrative Code of the Russian Federation (violation of the rules of medical devices circulation), which in case of legal entities is punishable by a fine amounting from 30,000 to 50,000 rubles.
Secondly, the state control policy is based on a risk-oriented approach. “A fine of 30,000 rubles will not frighten any of the manufacturers much. But there is another thing: all state control measures today are taken into account for the purposes of risk assessment. A manufacturer’s risk level that was assigned as low at the start can be replaced by a high risk. And inspections of your business will become more frequent. And this will give a us free hand in relation to both unscheduled and planned control measures,” the deputy head of Roszdravnadzor said.
He noted that the department is aware that brute force is feasible where the problem cannot be solved otherwise. “We can use a simple way to do it, and we may come out with such a proposal and apply to the working group on the Regulatory Guillotine. We simply propose to publicize the data on the introduction into circulation. What I mean is creating a service to check the legality of circulation of a medical device,” Dmitry Pavlyukov said.
The initiative of Roszdravnadzor to report on each medical device released or imported into the country became known in May 2021. Initially, it was assumed that manufacturers and importers would submit data on medical devices within five working days. As it was explained in the department, Roszdravnadzor needs the information “to conduct an analysis aimed at medical devices safety monitoring.” There was no special sanction, however, for the absence of data. The system was established by Order No. 11020 of November 25, 2021 and has been operational since March 1, 2022.