Manufacturers and importers will be obliged to report on the introduction of medical devices into circulation within 15 days
Roszdravnadzor has published a draft procedure for submitting information about medical devices, which will be required to transfer manufacturers or importers of specialized products. The data will be uploaded by market participants through their personal account on the Roszdravnadzor website, the list of information provided will include information on batches, batches, completeness, production date, expiration date of medical devices, and 15 working days will be allotted to their transfer to the regulator.
The manufacturer will have to upload the data to his personal account on the website of the automated information system (AIS) of Roszdravnadzor within 15 working days from the date of production of the medical device and assignment of a marking or identification number to it, and the importer – within a similar period from the date of release from the customs procedure.
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 this data, you will need the registration number of the customs declaration for goods and the date of its registration.
The draft order does not imply responsibility for non-transmission of data within the specified time period, however, if incomplete or inaccurate information is revealed, they “are subject to correction in order to ensure their completeness and reliability.”
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 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 of April 3, 2020. In particular, suppliers are obliged to provide information on the import of medical equipment consignments, as well as data on their sale, export or destruction through the AIS of Roszdravnadzor.
In August 2021, the Government of the Russian Federation 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.