For the attention of subjects of circulation of medical devices

In connection with the numerous applications from applicants on the issues of amending the documents contained in the registration dossier of medical devices registered in accordance with the Decree of the Government of the Russian Federation dated March 18, 2020 No. 299 “On Amendments to the Rules for State Registration of Medical Devices”, Roszdravnadzor reports the following.

Amendments to the documents contained in the registration dossier of medical devices registered in accordance with the Decree of the Government of the Russian Federation dated March 18, 2020 No. 299 is carried out after a decision has been made to confirm the state registration of medical devices.