Mass media inform about the readiness of the Federal Service for Surveillance in Healthcare to provide market participants with access to information about manufactured medical devices. To do this, a specialized system will be created that provides information on the legality of the trade circulation of devices upon entering of the number of the registration certificate or the serial / factory number of the item itself. The aim is to motivate market participants to enter timely the data on new incoming products into the electronic database, which has been operating since March, 2022.
This decision was announced by Dmitry Pavlyukov, Deputy Head of the Federal Service for Surveillance in Healthcare, at the XIV Congress of Pharmaceutical and Medical Industry Workers. He considers that it is necessary to speed up the entry of data on medical products manufactured and imported from abroad into the general control and monitoring system, due to the fact that hundreds of suppliers use registration services, and only about forty companies entered data into the database. Pavlyukov also outlined several ways to achieve this goal.
The first way is administrative liability for violation of the rules for the trade of medical devices in accordance with Article 6.28 of the Code of Administrative Offenses of the Russian Federation. In this case, legal entities that have delayed the provision of information to the system should face a fine in the amount of 30 to 50 thousand rubles.
Since such money amounts may seem insignificant for many manufacturers, the next step will be state control and risk assessment, allowing authorized auditors, in case of violation or delay, to appoint scheduled and unannounced inspections in relation to the companies producing medical devices that are not included in the monitoring system.
Pavlyukov considers such a decision as too tough. The proposed alternative – the publication of a database on medical devices – seems to him a simpler and trouble-free solution to the problem.
Potential consumers can easily find out if a product is legally traded by its number. In addition, the bet is also made on healthy competition: manufacturers themselves will motivate each other to provide data timely in order to satisfy demand.
The initiative itself appeared in March, 2021. Order No. 11020 dated the 25th of November, 2022, established the rules for the operation of the system, and the system already started working in March, 2022. Initially, the data had to be entered within 5 days, but there were no fines or other penalties for ignoring this recommendation.
Now we are talking about the mandatory nature of the procedure, and the period for providing information has been increased to 15 days. For manufacturers, the starting point will be the release of the product with the assignment of an identification number and an appropriate marking, and for importers – the finishing of customs control procedure.