Registration of medical devices in case of their defects or the risk of defects

Registration of medical devices is a state procedure, the purpose of which is to allow the release to the market of the Russian Federation only high–quality and safe medical devices that have been tested in accordance with current norms and standards.

Only after passing the registration procedure, manufacturers get access to the circulation of products on the territory of Russia.


Regulatory document regulating the cancellation of the registration certificate:

The registering body decides to cancel the state registration of a medical device on the basis of paragraph 57 of the Decree of the Government of the Russian Federation of December 27, 2012 N 1416 "On approval of the Rules for state registration of medical devices". There is no state fee for revocation of the registration certificate. At the same time, the manufacturer of a medical device or an organization importing a medical device into the territory of the Russian Federation, at least six months before the planned suspension or termination of the production of medical devices or importation into the territory of the Russian Federation, notify the federal executive authority exercising functions of control and supervision in the field of healthcare*. *Federal Law No. 323-FZ of November 21, 2011 "On the Basics of protecting the Health of citizens in the Russian Federation" Article 38, Part 25 was introduced by Federal Law No. 64-FZ of 26.03.2022.



Collection and analysis of information/documentation
Development of accompanying documents
Collection and submission of documents
Making a decision to cancel the validity of the registration certificate
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