Medical Device Registration

In Russia, all medical devices for diagnostic and therapeutic use must be registered in Moscow at the central office of the Federal Service for Surveillance in Healthcare and Social Development (Roszdravnadzor), which issues a registration certificate at the end of the process. The certificate states the name of the manufacturer, the device name, its intended use and its risk class for the patient.

If the medical device is a unit made up of several components (modules), annexes must be attached to the registration certificate listing all components and any accessories provided with the device. If components (modules) are supplied by different manufacturers and sold under their own brand, a separate registration certificate must be issued for each component. In that case, before starting the registration, it is advisable to check whether the component has not already been registered. A module’s registration certificate must be issued to the manufacturer, who must provide written consent to the use of their product by the applicant for registration.

After receiving the registration certificate for medical devices, a GOST declaration of conformity will be issued, as well as Customs Union hygiene certificates. If the medical device is equipped with weighing or measuring instruments (pressure gauges, thermometers and various sensors), you will receive a metrology certificate.

Types and validity of the certificate

The certificate may be issued to a manufacturer that is also an importer, for mass production of devices, for all production, or for a single device. If the certificate is issued for production, it is valid indefinitely.

Documents required for certification

1. product HS code

2. device datasheet data

3. manual, reference book, instructions for use

4. certificate of registration in the companies register *

5. free sales certificate issued by the Ministry of Health *

6. quality certificates: — ISO 9001:2000 and/or ISO 13485:2003 certified * — CE 93/42 certificate/declaration of conformity * (for reagents and analyzers EC 98/79)

7. test reports: — ISO 10993 biocompatibility — General safety standards IEC601-1 — Electromagnetic compatibility — 601-1-2

8. additional documentation may be required on a case-by-case basis

9. power of attorney with a notary-certified legal signature of the representative *

Medical-device registration is a rather complex procedure that, in addition to a solid knowledge of bureaucratic procedures, requires specialized knowledge of medicine. We therefore recommend contacting qualified personnel. We are always at your disposal for any additional questions and information you may need.