Registration of medical devices according to the Russian Federation rules
Registration of medical devices according to the Russian Federation rules
Registration of medical devices is a complex multi-stage process that requires specific knowledge and, more importantly, relevant experience. That is why when you register a medical device with the help of KC-PROF experts you are guaranteed to receive a registration certificate in the shortest time possible. This result comes from the coordinated work of highly qualified experts with many years of experience in the field of medical device circulation. Our department of medical device registration consists of 9 experts, including 2 candidates of technical and 1 candidate of biological sciences.
What is registration and why is it necessary to register medical devices?
Following paragraph 4 of Article 38 of the Federal Law N 323-FZ “On the Basics of Protecting the Health of Citizens in the Russian Federation” dated November 21, 2011, the circulation of medical devices is allowed on the territory of the Russian Federation only if they were registered in the procedure established by the Government of the Russian Federation, by its authorized federal executive body.
Registration of medical devices is a state procedure developed to bring to the market only those products which are effective, safe and have high quality. The registration certificate (RC) is a document which confirms the compliance of medical devices with the established requirements and the fact of their registration in Russia. Therefore, RC is a document mandatory for the circulation of a medical device on the Russian market. In other words, the registration of medical devices is a prerequisite for their import, use, sale, as well as production on the territory of the Russian Federation.
Registration of medical devices on the territory of the Russian Federation is conducted by the Federal Service for Supervision of Healthcare of the Russian Federation (Roszdravnadzor). In the process of state registration, Roszdravnadzor sends the registration dossier of a medical device to one of the subordinate organizations, FSBI VNIIIMT or FSBI NIK (formerly called FSBI CMIKEE), for quality, safety and effectiveness examination.
Medical devices registration chart
The regulations for state registration of medical devices are determined by the Decree of the Government of the Russian Federation No. 1416 “On Approval of the Rules for State Registration of Medical Devices” dated December 27, 2012. These rules are reviewed periodically, which creates additional problems for all market participants since it is quite difficult for manufacturers and distributors of medical devices to keep track of these changes. The latest changes to the registration procedure have been made by the Decree of the Government of the Russian Federation No. 633 “On Amending the Rules for State Registration of Medical Devices” dated May 31, 2018. Certain changes to the procedure cause changes in the documents which regulate the activities of Roszdravnadzor and its expert organizations. Thus, most recently, there have been published guidelines on the procedure of the quality, effectiveness and safety examination of the medical devices for state registration. We monitor all changes in the regulatory field and take them into account when preparing documents for our Clients.
In order to facilitate all market participants, we have prepared a medical device registration chart, which we promptly update, taking into account all changes introduced.
Registration according to the rules of the Russian Federation or the EAEU?
Types of products subject to mandatory registration as medical devices
Medical equipment:
Devices used for medical purposes (dmp):
Specialized software:
Documents for the registration of medical devices
In order to develop a registration dossier (a set of documents required for the registration of a medical device) for a product manufactured outside of Russia, the following documents will be required:
Depending on the complexity of the medical device, its risk class, and functional characteristics, the list of documents can change.
Terms for receiving registration certificates for medical devices
The duration of registration depends on the risk class of the medical device, the chosen registration procedure, the required amount of laboratory tests. We register products in a very short time as we carry out the individual steps of the procedure simultaneously where possible, which saves your time and sets us apart from our competitors.
At an average, the registration of medical devices in our company is carried out in the following terms:
If you already have certain documents from the registration dossier and have completed certain stages of registration, the terms of these services can be significantly reduced.
The circulation of medical devices is subject to state control. Thus, Article 235.1 of the Criminal Code of the Russian Federation states that production of medical devices without a special permit (license) by the officials is liable to a penalty in the form of imprisonment for up to 8 years with a fine of up to 3 million rubles. Following Article 6.33 of the Administrative Code of the Russian Federation, the production or sale of unregistered medical devices by legal entities is punishable by a fine of up to 5 million rubles or administrative suspension of activity for up to 90 days.
