How to find out if a medical device is registered or not?

Registration certificate (RC) is a document that confirms that a medical device can be used on the territory of the Russian Federation. The executive authority for monitoring and supervision in the field of organizing and ensuring the protection of public health is the Federal Service for Surveillance in Healthcare (Roszdravnadzor). All information about the registration process for a medical device (MD) can be obtained on the website https://roszdravnadzor.gov.ru/.

On the main page of the site, go to the “Services” section.

To search for a registered MD, you should use the service: State register of medical devices and of organizations (individual entrepreneurs) engaged in the production and manufacture of medical devices.

Knowledge of what information will help in the basic search?

  1. Name of the medical device;
  2. Registration certificate number;
  3. MD registration date;
  4. Applicant’s name and address;
  5. Manufacturer’s name and address;

The search can be performed either by one parameter or by their combination. To do this, we will use the advanced search.

In an advanced search, you can specify all the available information on the MD to find it quickly.

If after all the manipulations the MD does not appear in the registry, then it is not registered in the territory of Russian Federation and cannot be circulated inside Russian Federation.

References

  1. Federal Service for Surveillance in Healthcare, available at: https://roszdravnadzor.gov.ru/, свободный (accessed: 09.12.2020);