Registration of Medical Devices - МедРег Консалтинг

The registration of medical devices in the Russian Federation is a procedure intended to permit the circulation of quality and safe medical products within the domestic market. Furthermore, in line with the Federal Law dated November 21, 2011 “On the Fundamentals of Health Protection of Citizens of the Russian Federation”, only those medical devices that are registered in accordance with the requirements established by the Government of the Russian Federation are permitted for sale within the country.

What is included in the concept of “circulation” of medical devices?

It is strictly prohibited to engage in any of the aforementioned activities in relation to medical devices that have not undergone state registration and do not have a registration certificate. It is important to note that those who circulate unregistered devices or equipment may be held to account, whether administratively or criminally. In the first case, the individual in question may be subject to a fine.

In what situations may criminal liability be incurred?

In what circumstances is registration of medical devices not required?

In the case of medical devices that are customized and intended for personal use only. It is important to note that the device in question must be used by a specific patient. As an illustration, should a bespoke medical bed be commissioned, it is to be used by a single individual. In all other cases, registration is a mandatory requirement;
It would be beneficial to consider the import and export of medical devices for the purpose of doping control, as well as various studies and tests for scientific purposes.

How medical devices are registered: stages, peculiarities and nuances

The procedure is divided into 2 types: registration of medical devices within the EAEU and registration of medical devices within the national procedure. Each of these types has certain features and nuances, which will be discussed in more detail in the relevant sections. Below we would like to provide a generalized scheme for conducting the procedure within the national registration procedure.

It is important to note that the procedure will have its own characteristics, which will depend on a number of the following factors:

The entire procedure shall be carried out in strict accordance with the Government Decree dated December 27, 2012. Please find below a general overview of the procedure.

The registration process, as outlined in the General Rules, is conducted in the following sequence:

If the device is not of domestic production, then first of all, it is necessary to obtain permission to import samples into the territory for their subsequent registration;
The next step is to carry out all necessary studies (technical and toxicological);
After this, a package of documents and an application are submitted to Roszdravnadzor. Verification of documents usually takes no more than five days. If errors or mistakes are found, the documentation is returned for revision. And the updated documents must be re-submitted no later than one calendar month. This opportunity is provided only once, so it is necessary to approach the collection of the package of documents with special care;
After re-submission of documents (if there are no comments), a decision is made within 3 days, and the registration procedure is initiated. Then, an examination of the quality and safety of the products is carried out, after which Roszdravnadzor shall issue permission to conduct clinical trials, while the registration procedure is suspended. The results of clinical trials and their completeness are checked within 10 days. Resumption of registration is possible after completion of the trials, for this it is necessary to submit a new application;

What are the key features of simplified registration of medical devices?

Today, there’s a big demand for simplified registration of medical devices in line with the Resolution dated March 18, 2020 (shoe covers, gloves, masks, etc.). In this case, it is possible to register without doing any extra research and it’ll be done within 64 working hours. All the necessary research can be performed within seven months.

The following devices can be registered in a simplified manner until December 31, 2021: masks, shoe covers, respirators, gloves and medical gowns, thermometers, artificial lung ventilation devices, oxygenators, etc. It should be noted that provided that disposable devices are registered at the place of production, their sale without registration on the territory of the Russian Federation is permitted. In such instances, there is no obligation to register a series (batches) of medical devices.

Where to apply professional assistance in registration of medical devices?

As previously stated, the process of registering medical devices is complex and requires meticulous attention to detail. To avoid potential issues and streamline the procedure, it is advisable to entrust the procedure to professionals. Our company offers a comprehensive range of registration services tailored to meet your specific needs.

MedReg Consulting employs a team of highly qualified specialists, including experts, lawyers, engineers and others, who are well-versed in the latest developments and intricacies of medical law. Our specialists have extensive experience dealing with complex cases and possess a wealth of knowledge, which minimizes the risk of an unfavorable outcome. We are contacted by clients even after they have already received a refusal to register. We also assist clients at various stages of preparing documents for the registration of a medical device. Our team is adept at solving any problems that may arise.

The range of services provided is extensive and includes obtaining a registration certificate, conducting tests and research, appealing expert assessments, pre-trial resolution of issues, preparing technical and operational documents, consulting work, preparing documentation for obtaining registration, assistance in obtaining the original (duplicate) of the registration certificate, and more.

What reasons might there be for contacting us?

Our specialists are highly educated and regularly engage in advanced training courses, active scientific work, participation in various conferences, forums and seminars, knowledge exchange and the acquisition of new expertise.

What is the cost of our services? It is impossible to give a clear answer, because everything depends on many factors: the service chosen, what stage of registration is, what is the risk class and many other issues. To clarify the prices, we recommend contacting our experts at the numbers listed on the website, or fill out a simple application form. Our specialists will fulfill contractual obligations efficiently and within the strictly agreed time frame, and you will not have to worry about this.

Our company offers a comprehensive range of services related to the registration of medical devices including licensing of production and maintenance, declaration, amendments to registration documents and registration certificate, and the development of a set of registration documentation for a medical device. Our highly skilled specialists provide these services to the highest standards and at competitive prices.

We are confident that once you contact us, you will be convinced of our value and return as a customer. Our website lists our partners and regular customers, which include some of the largest medical organizations and manufacturers of medical devices in the industry. This demonstrates that our company is a trusted partner for many leading organizations and manufacturers of medical devices in the medical sector.