Medical devices entered into the market should be registered by lots by a special service of the Federal Service for Surveillance in Healthcare
A new function appeared on the web-site of the Federal Service for Surveillance in Healthcare that is available in the applicant’s personal profile. It is intended to help the manufacturers and importers to add information on series and lots of their devices according to the requirements established and published by the Service.
The register service is based on the provisions of the Order of the Federal Service for Surveillance in Healthcare No.11020 dated 25.11.2021 on recording of medical devices entered into the market by units and by lots. The same scheme has already been used since 2019 for recording of medical drugs and pharmaceutical substances.
The use can use the personal profile to enter the required data in two ways: manually or with use of xml-file. In the first case, the applicant fills all the fields by himself. When using a semi-automated mode, it is enough just to enter the information on the manufacturer and to apply the xml-file.
The web-site contains a detailed instruction on use of the modes and the requirements to formatting of margins and text with samples.
The applicant should enter all the required data on lots (series) and/or serial numbers within 15 working days since entry of the medical device to the market.