• English
  • Русский
8 (800) 505-34-91
(звонок из регионов бесплатный)
TUV SUD in EEU countries
150 years of inspiring trust
 

Certificate of State Registration of Medical Products Issued by the Federal Service for Surveillance in Healthcare (Roszdravnadzor)

Roszdravnadzor Certificate of Registration

Roszdravnadzor Certificate of Registration

The certificate of registration of a medical product is required for manufacturers to import and sell any instruments, apparatuses, devices, materials and other products to be used for any medical purpose in the Russian Federation.

This certificate is issued by the Federal Service for Surveillance in Healthcare if the results of trials have confirmed the product quality and safety.

The state registration of medical products needs to be carried out by the product developer, manufacturer or their authorized representative. The medical device/equipment registration certificate is issued in perpetuity.

Any use of medical products not registered with Roszdravnadzor is prohibited in the Russian Federation.

How to Obtain the Registration Certificate

To register medical products with Roszdravnadzor, the manufacturer should file an application for the state registration and submit a set of documents to support the application. Today the registration of medical devices with Roszdravnadzor is considered one of the most complicated certificate issuance procedures; however, such complexity is dictated by the need to ensure protection against any risks to human health and safety.

Thus, to obtain the registration certificate from Roszdravnadzor, it is necessary to submit an application for state registration of the medical product together with the following documents:

  • copy of a document confirming powers of the manufacturer’s authorized representative;
  • information about regulatory documentation for the medical product;
  • manufacturer’s technical documentation for the medical product;
  • manufacturer’s operating documentation for the medical product, including package inserts or user manuals;
  • photographic images of the medical product together with all accessories necessary for intended use thereof (min. size 18 x 24 cm);
  • documents confirming the results of technical trials of the medical product;
  • documents confirming the results of toxicological studies of the medical product the use of which implies human body contact;
  • documents confirming the results of trials of the medical device for the purpose of approval of the type of measuring instruments (with respect to medical products referred to measuring instruments in the field of government regulation of the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation);
  • list of documents submitted for the registration of the medical device with Roszdravnadzor.

If the documents to be submitted to Roszdravnadzor for the state registration of medical products are in a foreign language, they shall be submitted with a duly notarized translation into Russian.

Registration of Medical Devices with Roszdravnadzor

Roszdravnadzor issues the registration certificate in accordance with the Regulations on Medical Product State Registration approved by RF Government Resolution No. 1416 on Approval of Regulations on Medical Product State Registration, dated December 27, 2012. The RF Government Resolution came into effect on January 1, 2013.

The timeframe and sequence of administrative procedures and actions to be taken by the registration authority are established pursuant to the Administrative Regulations on Provision of the State Service of State Registration of Medical products, as developed in line with Order 373 of the RF Ministry of Health, dated May 16, 2011.