MEDICAL DEVICE REGISTRATION IN RUSSIA
In accordance with article 38 of the federal law of 21.11.2011 N 323-FZ, dedicated to the protection of the health of citizens, only those medical products that have passed the state registration procedure in accordance with the established procedure are allowed for free sale in Russia. The fact of its passage is confirmed by the issuance of a special document – a registration certificate. The requirement for its availability applies to all types of medical products that are available for free sale.
However, if the product is intended for individual use by a specific patient and is made specifically for him by private order, taking into account the instructions of the attending physician, it is not necessary to register such a product.
The procedure for state registration is determined by the provisions of Government Decree No. 1416 of December 27, 2012. This regulatory act indicates that Roszdravnadzor is responsible for state registration of medical goods. In this situation, the applicant will need to confirm the quality, efficacy and safety of his product, at his own expense organizing and conducting a number of important studies.