Overview of Russia’s Mandatory Registration Process

According to current legislation (Article 38 of Federal Law No. 323-FZ dated November 23, 2011 “On Protection of Public Health”), all medical devices distributed within the Russian Federation must be registered. Possession of a registration certificate confirms the quality, safety and efficacy of a medical device, and allows it to circulate in the Russian market. Completing technical, toxicological (for devices with direct or indirect human contact) and clinical testing is mandatory for registration. The medical device registration process follows the guidelines of two key regulations:

1) Decree No. 1416 of the Government of the Russian Federation dated December 27, 2012 (with amendments and supplements dated October 17, 2013, July 17 2014, February 10 2017) “On Approval of the Rules for State Registration of Medical Devices”.

2) Order No. 885n dated August 30, 2021 “On Approval of the Procedure for Assessing Conformity of Medical Devices in the Form of Technical Testing, Toxicological Research, Clinical Testing for State Registration of Medical Devices.”

Our company has long-standing partnerships with accredited technical and toxicological laboratories. We guarantee our testing experts have the specialized knowledge and skills to competently conduct tests and prepare accurate protocols documenting technical test results.

The next step is to compile the documentation package for regulatory submission and file for state registration. Selecting a hospital appropriate to the medical device’s intended use to conduct clinical performance testing plays an important role in securing the registration certificate. A list of accredited medical institutions can be found on the website of the Federal Service for Surveillance in Healthcare.

Based on the safety and efficacy assessment, the federal agency issues an open-ended registration certificate to approved medical devices.