Market participants were obliged to report on manufactured and imported medical devices from March 1, 2022
Roszdravnadzor approved the procedure for submitting information about medical devices to the automated information system (AIS) of the department. From March 1, 2022, manufacturers and importers will be required to transfer data on batches, batches, completeness, date of production, expiration date of medical devices, 15 working days will be allotted for their transfer to the regulator.
The regulation was approved by order of the department No. 11020 dated November 25, 2021. From March 1, 2022, market participants are required to upload data to the personal account of the AIS Roszdravnadzor within 15 working days from the date of production of the medical device and assigning it a marking or identification number in the case of the manufacturer and within a similar period from the date of release from the customs procedure for the importer.
The department proposes to include production data in the list of information, including the number, series, identification number, information on the registration certificate, composition, completeness, accessories, the number of MI in a batch or pieces, as well as the production date, expiration date, number and date of the universal transfer document. For importers, in addition to these data, you will need the registration number of the customs declaration for goods and the date of its registration.
The initiative of Roszdravnadzor to report on each medical device released or imported into the country became known in May 2021. It was originally envisaged that manufacturers and importers would transmit MI data within five business days. As explained in the department, the information is needed by Roszdravnadzor “for analysis in the framework of monitoring the safety of medical devices.” In addition, no separate sanction was foreseen for the lack of data.
In March 2021, the Government of the Russian Federation regulated the procedure for notification of the import of unregistered medical devices imported into the country to combat the spread of coronavirus by decree No. 430 dated April 3, 2020. In particular, suppliers are obliged to provide information on the import of MI consignments, as well as data on their sale, export or destruction through the AIS of Roszdravnadzor.
In August 2021, the government approved similar changes to the rules for importing medical products into Russia that are not subject to registration. The updates will take effect from March 1, 2022 and will be valid until January 1, 2027.