Registration of medical products
Registration of medical products is a state procedure, the purpose of which is to allow the release of high-quality and safe products to the Russian market.
Any tools, apparatus, instruments, equipment, materials and other products used for medical purposes, alone or in combination with each other, and also together with other accessories necessary for the use of these products for the intended purpose, including special software, and intended by the manufacturer (producer) for prevention, diagnosis, treatment and medical rehabilitation of diseases, monitoring the state of a human body, conducting medical research, restoring, replacing, changing the anatomical structure or physiological functions of a body, preventing or terminating pregnancy, the functional purpose of which is not realized by pharmacological, immunological, genetic or metabolic effects on a human body (hereinafter referred to as medical products) are subject to state registration.
Medical products made according to individual orders of patients, which are subject to special requirements for prescription by medical professionals and which are intended solely for personal use by a specific patient, are not subject to state registration.
The Federal Service for Surveillance in Healthcare (Roszdravnadzor) performs state registration of medical products.
State registration of medical products is performed on the basis of the results of technical tests, toxicological studies, clinical trials, which are forms of conformity assessment of medical products taking into account the classification, depending on the potential risk of their use, and quality, effectiveness and safety examination of medical products, taking into account the classification depending the potential risk of their use, as well as tests to validate the type of measuring devices (with regard to medical products relating to measuring devices in the field of state regulation of ensuring measurements uniformity, a list of which is approved by the Ministry of Healthcare of the Russian Federation).
A Registration Certificate for a medical device is a document confirming the fact of the state registration of a medical product. The registration authority approves the form of a Registration Certificate.
Part 4 of Article 38 of the Federal Law dated November 21, 2011 No. 323-FZ “On the basis of health protection of citizens in the Russian Federation” allows the circulation of medical products registered in the manner established by the Government of the Russian Federation, through the federal body of executive authorities authorized by it.
Federal Law No. 532-FZ dated December 31, 2014 provides for administrative and criminal liability for illegal manufacture of medical products, circulation of falsified, poor-quality, counterfeit and unregistered medical products, falsification of documents for medical products or their packaging.