RUSTANDARD - Product Registration and Certification
GOST R, Gost Russia, Gost Standard, RTN, GGTN

MEDICAL DEVICE REGISTRATION IN RUSSIA - (Medical device registration certificate)

In the Russian Federation all medical devices for use diagnostic and therapeutic purposes must be registered in Moscow, at the central department of the Federal Service on Surveillance in Healthcare and Social Development (Roszdravnadzor), which at the end of a process issued a certificate of registration. The certificate shall indicate the name of the producer, the name of device, the intended use and the class of potential risk to the patient, information on any similar.
If the medical device is a unit complex, consisting of more components (modules), the certificate of registration shall be accompanied by a Annex, that shall identify all components that make up and any accessories with which it is provided.
If the components (modules) are produced by different manufacturers and marketed under their own brand, the certificate of registration used for each component. In this case, before proceeding with the registration is advisable to verify that the component in question has not already been registered. To do this simply go to National Directory of medical devices and do a search. The certificate of registration of the component should be made payable to producer, who must provide a letter of consent to use of its product by the applicant for registration.
After obtaining the certificate of registration of medical devices will provide the declaration of conformity GOST R, and where predicted, also the Customs Union hygienic registration certificate.
If the medical device is provided with the tools of weight or measure (gauges, thermometers, and various sensors) you will also get the metrological certificate.

  Summary outline of the registration procedure (ITA 72 KB)

Normative References
The registration of medical devices in Russia is regulated by the Decree of the Government of the Russian Federation No. 1416 of 27/12/2012.

  Decree of the Government of the Russian Federation No. 1416 of 27/12/2012 (ENG 77 KB)

  Decree of Ministry of Health of the Russian Federation No. 737n of 14/10/2013 (RUS 2,65 MB)

  Lists of authorized Testing Laboratories (RUS 153 KB)

  Guidelines for the preparation of registration dossier (RUS 3,3 MB)

  Guidelines for medical device classification (RUS 279 KB)

  New Medical Device Nomenclature (in effect from 01/2015)

Types and validity of the certificate
The certificate can be issued to the producer who is the importer, for the mass production of devices for playing or for a single device. If the certificate is issued to the producer is valid indefinitely.

Documents required
1) Technical File
2) ISO 9001/13485* certificate
3) 93/42/EEC* certificate/declaration of conformity (98/79/EC for IVD)
4) Power of attorney**
5) Product samples

N.B.: An additional documents might be be required for every single case.

*A certified copy with Apostille stamp is required.
**The original with Apostille stamp is required.

Release times and costs

First issue: up to 12 months
Upgrading: up to 4 months

The whole registration procedure (each registration certificate) costs approximately 5.000 - 20.000 EURO, depending on the type of medical device.

Check on-line state of the practice
To check the status of your file (click here)
Enter the number and the date of the application that you have been notified.

Where and when

Federal Service on Surveillance in Healthcare
Headquarters: Moscow 109074, Slavjanskaja ploshad, 4 building 1. Tel: +7 495 6983098
Wednesday: 10:00 to 12:45, 14:00-17:00
Friday: 10:00 a.m. to 12:45 p.m., 2:00 p.m. to 4:00 p.m.

The registration of medical devices is a fairly complex procedure, which in addition to an excellent knowledge of bureaucratic procedures, requires specific knowledge in the medical field. Therefore, we recommend contacting qualified service personnel. We are always at your disposal for any further questions or need information.

Last Updated on: 19 March 2024