Procedure for the Registration of Medical Devices (Medical Products)

Anna Ivanova, Attorney at BRACE Law Firm

BRACE Law Firm ©

June 25, 2022

According to Article 38 of Federal Law No. 323-FZ dated November 21, 2011, On the Fundamentals of Health Protection of Citizens in the Russian Federation (the "Law No. 323-FZ" or the "Law on Health Protection"), medical devices are any instruments, apparatuses, devices, equipment, materials, and other products used for medical purposes separately or in combination with each other, as well as together with other accessories necessary for the intended use of the specified products, including special software. These devices are intended by the manufacturer for the prevention, diagnosis, treatment, and medical rehabilitation of diseases, monitoring the state of the human body, conducting medical research, restoration, replacement, modification of the anatomical structure or physiological functions of the body, and the prevention or termination of pregnancy, provided their functional purpose is not realized through pharmacological, immunological, genetic, or metabolic effects on the human body.

The circulation of medical devices includes technical testing, toxicological studies, clinical trials, expertise of the quality, efficiency, and safety of medical devices, their state registration, production, manufacturing, import into the territory of the Russian Federation, export from the territory of the Russian Federation, confirmation of compliance, storage, transportation, sale, installation, adjustment, application, operation (including technical maintenance provided for by the normative, technical, and (or) operational documentation of the manufacturer), as well as repair, disposal, or destruction.

Thus, as a general rule, medical devices are subject to state registration. However, certain medical devices are exempt from such registration, including:

• medical devices listed in paragraph 11 of Article 4 of the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Framework of the Eurasian Economic Union dated December 23, 2014, specifically:

• those imported by individuals for personal use into the customs territory of the EAEU;
• those manufactured in the territory of a member state according to individual patient orders exclusively for personal use;
• those imported for use by employees of diplomatic missions and consular offices;
• those imported into the customs territory of the Union to provide medical assistance to passengers and crew members of vehicles, train crews, and vehicle drivers arriving in the territory of the Union;
• those imported to provide medical assistance to participants in international cultural and sports events and participants in international expeditions, as well as for holding exhibitions;
• those imported for research (testing), including for scientific purposes;
• those imported as humanitarian aid in cases determined by the legislation of the member states;

• medical devices imported into the territory of the Russian Federation to provide medical assistance for life-saving indications for a specific patient;
• medical devices produced in the Russian Federation for export outside the EAEU territory and not intended for use within the EAEU territory, as well as those produced in Russia for conducting research and development (R&D) or testing;
• medical devices intended for use in the territory of an international medical cluster or in the territories of innovative scientific and technological centers;
• medical devices representing sets, kits, and first-aid kits consisting of registered medical devices (excluding medical devices connected to or equipped with an energy source) and (or) medicinal products combined in a common package, provided that the secondary (consumer) packaging or primary packaging of the medicinal product (if secondary packaging is not provided) of the manufacturer of each product is preserved along with its labeling;
• medical devices intended for the diagnosis of diseases by testing samples of human biological material outside the body, which are manufactured and used within the same medical organization.

Consequently, if medical devices do not fall under the exceptions mentioned above, they are subject to state registration.

It is important to note that starting January 1, 2022, registration under EAEU rules was intended to become mandatory. However, the Council of the Eurasian Economic Commission (the "EEC") decided to extend national registration until December 31, 2022. Thus, currently, registration under EAEU rules is possible on a voluntary basis. Applicants also retain the right to apply to Roszdravnadzor for the registration of medical devices under national rules until the end of the current year.

Therefore, both the Rules for the State Registration of Medical Devices, approved by Decree of the Government of the Russian Federation No. 1416 dated December 27, 2012, and the Rules for the Registration and Expertise of the Safety, Quality, and Efficiency of Medical Devices, approved by Decision of the Council of the Eurasian Economic Commission No. 46 dated February 12, 2016, are currently in effect in Russia.

This article examines the specifics of the legal regulation of medical device registration under both the national procedure and the EAEU rules.

National Procedure for the Registration of Medical Devices

The rules for registering medical devices under the national procedure are approved by Decree of the Government of the Russian Federation No. 1416 dated December 27, 2012.

This document establishes that state registration for medical devices is conducted based on:

1. results of technical testing;
2. toxicological studies;
3. clinical trials, which serve as forms of conformity assessment for medical devices based on their potential risk classification;
4. expertise of the quality, efficiency, and safety of medical devices based on their potential risk classification;
5. testing for the purpose of measuring instrument type approval (for medical devices categorized as measuring instruments in the field of state regulation, the list of which is approved by the Ministry of Health).

Technical testing involves tests to determine the compliance of the characteristics of a medical device with the requirements of normative, technical, and operational documentation and to decide on the feasibility of clinical trials. These technical testing documents must be attached to the application. Toxicological results are required for medical devices that contact the human body. Documents confirming measuring instrument type approval testing are required for devices listed in Decision of the Council of the Eurasian Economic Commission No. 42 dated February 12, 2016, such as thermometers, scales, and blood pressure monitors.

Clinical trials and safety expertise are conducted after the registration application is filed. The applicant may submit a draft clinical trial plan with supporting materials alongside the application.

Within 3 business days of receiving the application and documents, the registration authority decides whether to start the registration procedure. If the information is incomplete, the applicant has 30 days to eliminate discrepancies. If not corrected within this period, the application is returned.

Once the procedure begins, the registration authority issues an assignment to conduct an expertise of the quality, efficiency, and safety of the medical device to a federal state budgetary institution under its jurisdiction. Currently, Roszdravnadzor is the registration authority, and the expertise is conducted by the FGBU National Institute for Quality of Roszdravnadzor.

The expertise follows the Procedure for Organizing and Conducting Expertise of the Quality, Efficiency, and Safety of Medical Devices, approved by Order of the Ministry of Health of Russia No. 206n dated March 20, 2020. First, the authority evaluates the application to determine the feasibility of clinical trials. Next, it reviews the completeness and results of the technical testing, toxicological studies, clinical trials, and measuring instrument approval tests.

Following the expertise, the institution prepares a conclusion on the possibility of conducting clinical trials. The expert institution cannot request additional materials directly from the applicant; it must notify Roszdravnadzor, which then informs the applicant. The applicant has 50 business days to provide missing documents. Upon receiving a positive conclusion, Roszdravnadzor either issues a clinical trial permit or refuses registration. A conclusion stating that clinical trials are impossible serves as the basis for a refusal.

Clinical trials for most devices, excluding Class 1 devices, medical software (including AI-based software), and in vitro diagnostic devices, are part of the conformity assessment. Risk classes are defined by Order of the Ministry of Health of Russia No. 4n dated June 6, 2012:

• Class 1 – low risk;
• Class 2a – medium risk;
• Class 2b – increased risk;
• Class 3 – high risk.

These trials require a permit from the registration authority and an ethical justification conclusion from the Ethics Council of the Ministry of Health of Russia. For Class 1, software, and in vitro devices, clinical trials are not required; instead, the applicant submits data confirming clinical efficiency and safety.

The procedure for these assessments is governed by Order of the Ministry of Health of Russia No. 885n dated August 30, 2021. Human clinical trials are required for:

• new types of medical devices;
• new complex, unique, or special medical technologies or methods;
• cases where existing clinical data fails to confirm efficiency and safety;
• devices containing new materials or known materials contacting organs where medical experience is lacking or contact is more prolonged than previously studied.

In other cases, trials are conducted as an analysis and evaluation of clinical data. The applicant must submit an application and device samples for these trials.

According to the Regulation on the Ethics Council, approved by Order of the Ministry of Health of Russia No. 58n dated February 8, 2013, the Council meets at least twice a month. These meetings result in a conclusion on the ethical justification of the trials. Medical organizations conducting trials must comply with Order of the Ministry of Health of Russia No. 300n dated May 16, 2013, including holding a valid medical license for the relevant services. Roszdravnadzor maintains a register of compliant organizations.

Roszdravnadzor suspends registration during clinical trials. After trials conclude, the applicant requests to resume registration. Results are sent back to the expert institution for a final review, after which Roszdravnadzor decides to issue a Registration Certificate or refuse state registration.

Grounds for a decision to refuse state registration of a medical device include:

• a conclusion from the expert institution that the quality, efficiency, and safety are not confirmed, or that the risk to citizens and medical workers exceeds the benefits;
• discrepancies between the submitted data and findings from state control over the circulation of medical devices.

Special procedures exist for devices used in combat, emergencies, or for treating dangerous diseases. A temporary Registration Certificate valid until January 1, 2025, can be issued under a simplified process per Decree of the Government of the Russian Federation No. 430 dated April 3, 2020.

Furthermore, simplified registration is available for devices experiencing shortages or risk of shortages due to economic sanctions. In such cases, the Registration Certificate is valid until September 1, 2023. Decree of the Government of the Russian Federation No. 552 dated April 1, 2022, established accelerated timelines for these procedures. For Class 1 devices, a temporary 150-day Registration Certificate can be issued without testing.

Current judicial practice shows that courts often support Roszdravnadzor in cases of challenging decisions to refuse state registration of medical devices. For example, in one case, an applicant submitted testing protocols confirming safety, but the expert expertise concluded otherwise. The court denied the claim, stating that Roszdravnadzor correctly identified that the devices could not replace each other and that efficiency was not confirmed.[1]

Disputes regarding state procurement are also common, particularly concerning the requirement to provide a Registration Certificate in a bid. The antimonopoly authority generally views such requirements as justified.[2]

Registration Procedure for Medical Devices within the EAEU

The Rules for the Registration and Expertise of the Safety, Quality, and Efficiency of Medical Devices, approved by Decision of the Council of the Eurasian Economic Commission No. 46 dated February 12, 2016 (the "EAEU Registration and Expertise Rules"), impose higher standards than the national procedure.

Specifics depend on the risk class, and a new requirement for manufacturing inspection has been introduced. If the registration dossier is insufficient, the authorized body (expert organization) of the reference state sends a request for clarification. The applicant has 60 business days to respond. Manufacturing inspection is mandatory for Class 2 and Class 3 devices.

Medical devices must meet the General Requirements for the Safety and Efficiency of Medical Devices, approved by Decision of the Council of the Eurasian Economic Commission No. 27 dated February 12, 2016. Devices must be effective for their intended purpose, minimize contamination risks, and reduce infection risks during manufacturing.

To register, the applicant chooses a reference state and at least one concerned state. They submit a registration dossier and an application for expertise. If information is missing during the initial analysis, the applicant has 30 business days to respond to the request. If information is missing during the expertise itself, the applicant has 60 business days to respond.

The reference state's expert organization has 45 business days to prepare an expert conclusion or decide to start a manufacturing inspection. The inspection process should not exceed 90 business days. Reports are sent to the expert organization and the applicant.

Grounds for the reference state to issue a conclusion to refuse registration of a medical device are:

• failure to confirm quality, efficiency, or safety;
• risks exceeding the benefits of use;
• unreliable data identified during state control.

If the conclusion is positive, the reference state uploads the dossier to its system and notifies the applicant to pay for coordination in the concerned states within 30 calendar days.

Failure to coordinate in a concerned state results in a refusal. If disagreements persist, the reference state may refer the matter to the Advisory Committee. While its decisions are recommendatory, the reference state uses them to make a final decision.

In conclusion, the EAEU procedure is more detailed and complex than the Russian national procedure, particularly regarding manufacturing inspections and coordination between states. However, EAEU Registration Certificates are valid indefinitely and allow for circulation across the entire Union, making this path more advantageous for applicants. Given the novelty of these rules, judicial practice is still developing.

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References

[1] Ruling of the Supreme Court of the Russian Federation No. 305-ES19-17064 dated October 7, 2019, in Case No. A40-172170/2018.

[2] Decision of the Vladimir FAS Russia No. 033/06/48-314/2022 dated May 17, 2022.