Manufacturers and importers will be obliged to report on every medical device released or imported into the country
Roszdravnadzor intends to oblige manufacturers and importers to report information about each medical device released or imported into the country within five working days. The data are needed to monitor the safety of the MI circulation, according to the explanatory note to the draft thematic order of the department.
According to the regulator’s plan, the manufacturer, within five working days after the release of the medical device or the assignment of a series or number to it, must enter into the automated information system (AIS) of Roszdravnadzor data on the name, version or model of the medical device, batch number, batch together with the serial number, batch size or batch in pieces, and also indicate the production date and service life. In addition, the system will need to enter data on the composition, configuration and list of accessories for medical devices, if any, as well as the number of the registration certificate and the date of its issue.
Similar information, according to the draft order, must be uploaded to the AIS of Roszdravnadzor by a distributor importing medical products into Russia from abroad, including from the territory of the EAEU countries. This will be provided for five working days from the date of release of the batch under the customs procedure.
As indicated in the explanatory note, the data is needed by Roszdravnadzor „for analysis within 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 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.
Importers are required to notify the department through AIS about batches or consignments of imported medical devices within three days, as well as weekly transmit data on their sales in the Russian Federation, export from the country or destruction. The new regulation, approved by Decree of the Government of the Russian Federation No. 337 of March 6, 2021, concerns medical devices imported for registration, testing, or disposable medical products registered abroad.