Amendments to the registration documentation are carried out if something has changed in the submitted registration dossier. Amendments under the national procedure is carried out until the end of 2026, then manufacturers need to switch to the registration procedure for the EAEU. The reasons for amendments can be very different - from changing the address of the manufacturer authorized representative to updating the old registration dossier. In this regard, the package of documents and the terms for amendments differ - from 1 month from the date of submission of all documents to 8-9 months. Please contact us, and we will help you to make the necessary changes in a timely manner, in the shortest possible time, and continue circulation of your medical device without the risks associated with a discrepancy between the real medical device and the registration dossier, which is stored in Roszdravnadzor. Roszdravnadzor is endowed with the function of monitoring the circulation of medical devices after their registration and carries out inspections of all subjects of circulation, selects samples of any medical devices, conducts tests and issues appropriate expert opinions. If the medical device has not passed the examination under state control, Roszdravnadzor notifies the authorized representative of the manufacturer about this and asks to eliminate inconsistencies, withdraw the product from the market, etc. If the authorized representative of the manufacturer does not eliminate these discrepancies, then Roszdravnadzor can apply various methods of influence up to until the suspension of the marketing authorization and criminal liability.