On 14 August 2012, a procedure came into force on the state registration of imported medical devices. Previously, this procedure was not regulated separately.
Upon the request of a manufacturer of a medical device or its authorised Russian representative, the Federal Service for the Supervision of Public Health and Social Development (“Roszdravnadzor”) issues permission for import within five days. Permission is issued free of charge and is valid for six months.
Permission may be denied in three cases:
- an applicant has not submitted all of the required documents;
- import of the medical device is limited by an international agreement or a decision of the Government of the Russian Federation; and/or
- the side effects, adverse reactions or other circumstances which threaten the life and health of citizens and medical personnel are not indicated in the user’s manual or instruction guide.
Additionally, on 14 August 2012, an Order of the Ministry of Health of the Russian Federation came into force, requiring those who handle medical devices to report any side effects and adverse effects discovered during the use of these medical devices to Roszdravnadzor. This order is obligatory for all those who handle medical devices, including those who sell, transport, store and test medical devices, as well as doctors, patients and others.
These measures are first of all intended to strengthen state monitoring of the quality and safety of medical devices. The handlers of medical devices will be held administratively responsible if they withhold information on side effects and adverse reactions resulting from the use of medical devices.
[Order No. 7n of the Ministry of Health of the Russian Federation “On Adopting the Procedure of State Registration of Medical Devices Imported to the Russian Federation”, dated 15 June 2012] [Order No. 12n of the Ministry of Health of the Russian Federation “On Adopting the Procedure by which the Handlers of Medical Devices Must Report Side Effects Not Indicated in the Instruction Guide of a Medical Device, on Adverse Reactions when Using It, on the Specifics of the Interworking of Medical Devices with Each Other, and on Circumstances which Threaten the Life and Health of Citizens and Medical Personnel during the Use of Medical Devices”, dated 20 June 2012]