E.M. ASTAPENKO, Candidate of Engineering Science, the Head of the Department for Organization of State Control and Registration of Medical Devices

D.Yu. PAVLYUKOV, Deputy Director

For citation: Astapenko E.M., Pavlyukov D. Yu. Medical devices in light of COVID-19: a new reality. – Vestnik Roszdravnadzora. – 2020. – Vol. 4. – P. 39–43.

DOI: https://doi.org/10.35576/2070-7940-2020-4-39-43

Keywords: medical devices, regulatory change, COVID-19, coronavirus, expedited registration of medical devices

 

Introduction

The article presents new approaches to regulating the circulation of medical devices developed with the emergence of a new coronavirus infection. The prospects for the further application of these approaches in the field of circulation of medical devices are described taking in account the gained experience and the analysis of law enforcement practice.

 

The issues of circulation of medical devices have recently become of increasing interest not only in a professional medical community, but in lives of ordinary citizens. Therefore, the challenges that civil society accepted as a result of the emergence of new coronavirus infection also affected the changes in legislation in the field of the circulation of medical devices aimed at accelerated market access of essential medical devices.

It worth noting that due to the current epidemiological situation the change of approaches in circulation of medical devices is observed in all countries of the world, and the Russian Federation is not an exclusion. When choosing approached to regulate the circulation of medical devices on the territory of the Russian Federation, world experience was taken into account. For example, in Europe the restrictions on the access to the market of medical devices for diagnosis of new coronavirus infection were lifted, which, on the one hand, led to a rapid filling of the market, from the other hand – further recalls from the market of such medical devices because of their low quality, that didn’t allow to reveal infected patients with due probability. China has identified its own manufacturers of medical devices for diagnosis of new coronavirus infection, the quality, effectivity and safety of which were confirmed by the regulatory authority. In the USA, recommendations for validation and confirmation of compliance while manufacturing medical devices for diagnosis new coronavirus infection were issued.

Considering the existing world experience in the Russian Federation it was decided to form a list of medical devices necessary for the provision of medical care in view of new coronavirus infection as well as its prevention, and to determine approaches to the access to the market. In this connection, for medical devices with a low degree of potential risk of use related to personal protective equipment an approach of accelerated registration on the territory of the Russian Federation was proposed subject to the provision of technical and operational documentation of the manufacturer, as well as the photos of these medical devices followed by during 150 working days from the date of registration, conducting necessary trials and tests. The list of these devices is represented in the Appendix to the Rules of State Registration of Medical Devices approved by the Decree of the Government of the Russian Federation №1416 dated 27.12.2012 “Adoption of rules for state registration of medical devices” (as amended by the Decree of the Russian Federation №299 dated 18.03.2020).

It should be noted that for the issuance of a registration certificate for a medical device a state fee in the amount of 7000 rubles is stipulated.

If the applicant submits properly completed documents, then Roszdravnadzor proceeds with registration of such medical devices within a period not exceeding 8 working days. As already mentioned, the applicant within the period not exceeding 150 working days from the date of state registration of a medical device, is obliged to submit to the registering authority a full set of documents stipulated by p. 57 (10) of the Rules for state registration of medical devices approved by the Decree of the Government of the Russian Federation №1416 dated 27.12.2012 in order to confirm the state registration of a medical device. It should be noted that technical and biocompatibility trials of such medical devices in order to confirm their state registration are conducted in the “All-Russian Scientific Research Institute of Medical Equipment” FSBI of Roszdravnadzor (hereafter “ASRIME” FSBI of Roszdravnadzor).

The decision to confirm the state registration of a medical device is taken on the basis of the statement formalized on the results of the expertise of quality, effectiveness and safety of a medical device. In case the applicant fails to submit documents within the specified timeframe to confirm the state registration of a medical device, Roszdravnadzor will decide to cancel its state registration.

It should be noted that with such registration scheme there is an increased responsibility on a manufacturer and its authorized representative for the quality, effectiveness and safety of a circulating medical device, since it can be put into the circulation before the state registration is confirmed. At the same time, if within the framework of state control over the circulation of medical devices a substandard medical device is revealed before the confirmation of its state registration, a subject responsible for its entry to the market will bear both administrative and criminal liability in the order prescribed by the legislation of the Russian Federation.

Please note that the state fee for the expertise of quality, effectiveness and safety of a medical device is paid in accordance with the legislation of the Russian Federation on taxes and fees and amounts to 45000 rubles for a class 1 medical device.

In order to provide methodological assistance applicants with the preparation of documents for state registration of medical devices, Roszdravnadzor has prepared and posted on the official website www.roszdravnadzor.gov.ru. Methodological recommendations on registration of medical devices with a low degree of potential risk of their use included in the list presented in the appendix to the Rules of state registration of medical devices approved by the Decree of the Government of the Russian Federation №1416 dated 27.12.2012.

For 5 months since the beginning of the accelerated procedure of state registration of a medical device described above Roszdravnadzor issued 1038 registration certificates (as of August 20, 2020), which is almost 3 times more of medical devices than there were registered previously (before March 18, 2020).

Besides, the Government of the Russian Federation based on the proposals of the Russian Ministry of Health has drawn up the list of medical devices which are meant for use in military activities, emergency situations, prevention and treatment of diseases constituting a danger to others, diseases and injuries gotten as a result of exposure of unfavorable chemical, biological, radiation factors and for which state registration of a batch (set) is possible. Specifics of the circulation of such medical devices., including medical devices for diagnosis of new coronavirus infection, artificial ventilator and membrane oxygenation are approved by the Decree of the Government of the Russian Federation №430 dated 03.04.2020 (hereafter – Features).

In accordance with the Specifics, documents for state registration of medical device may be sent by a developer, manufacturer (producer) or a person importing a medical device to the Russian Federation for the purpose of state registration (hereafter – applicant). Moreover, if the documents are prepared in a foreign language, they should be provided with a notarized translation into Russian, i.e., in accordance with this regulatory-legal act, a notarization of the translation of documents drawn up in a foreign language in the country of their origin is not required.

In addition to it, only operational documentation of medical device should be obligatorily submitted, and it is also possible to conduct testing under the sample program, depending on the type of medical device developed by expert institution and published on the official websites of expert institutions in the Internet information and telecommunication networks: “ASRIME” FSBI of Roszdravnadzor and “National Institute of Quality” FSBI of Roszdravnadzor.

Besides, on the official websites of these expert institutions of Roszdravnadzor there is a “Check-list for applicants for submitting documents for the purpose of state registration of a batch (set) of medical device in accordance with the Decree of the Government of the Russian Federation №430 dated 03.04.2020”.

According to the statistics an average duration of trials for state registration of medical device in accordance with the Specifics is 8 working days, the time period of issuing registration certificate including preparation of the report of possibility (impossibility) of state registration of a batch (set) of medical devices (in the absence of comments to submitted documents) is 5 working days.

In accordance with the Specifics, Roszdravnadzor registered 174 medical devices in 5 months. Particular attention is paid to the availability of medical devices in circulation on the territory of the Russian Federation for diagnosis of new coronavirus infection, Roszdravnadzor allowed the use of 159 of such medical devices, among them based on the method of polymerase chain reaction (PCR) – 33 (real-time 15), method of enzyme-linked multiplied immunoassay (ELISA) – 50 (3 of them are rapid-tests), method of lateral flow assay (LFA) – 89 (32 of them are rapid-tests).

It should be noted that in accordance with p.10 of Specifics it is allowed to import into the Russian Federation, sale, transportation, storage, use and disposal (elimination) of disposable medical devices not registered in the Russian Federation according to the list provided by the appendix, without getting the permission of Roszdravnadzor, if these devices are registered in the appropriate manner in the manufacturing country.

In this case, the application for state registration of a batch (set) of medical devices is not sent and state registration of these devices is not conducted. At the same time, the applicant is obliged within 3 working days from the date of the import into the Russian Federation of unregistered medical devices to send to the Federal Service for Surveillance in Healthcare the information about series (batches) of medical devices in accordance with Specifics. As of the end of August, 2020, more than 280 million units of such medical devices were imported into the territory of the Russian Federation.

It is important to stress that confirmation and verification of the fact of registration of such medical devices in the country of origin lies directly with the person who puts in force their importation and purchase, respectively. Procuracy and state control authorities including Roszdravnadzor can verify the compliance with this requirement within the framework of state control (inspection).

Regarding the state control over the circulation of medical devices during the period of epidemiological situation, control events are conducted only in the case of harm to life and health of citizens, scheduled checks are not conducted. However, due to the spread in the Internet information and telecommunication networks the information regarding rapid tests detecting antibodies to new coronavirus infection as well as low diagnostic sensitivity of test-systems for diagnosing new coronavirus infection, Roszdravnadzor published on the official website an information letter № 01И-945/20 dated 20.05.2020 “On the use of rapid-tests to detect antibodies to COVID-19” (hereafter – information letter), and also additional testing of registered test systems according to established order was conducted. Thereat it was found that at present the characteristics of test-systems obtained from the results of additional testing and studies correspond to those declared by the manufacturers during the state registration. Besides, it is noteworthy that in accordance with information letter rapid tests are screening tests, not recommended for laboratory diagnosis of COVID-19 and are not applicable in domestic conditions. At the same time, within the established powers, Roszdravnadzor and its territorial bodies continue to undermine the attempts of illegal offtake of unregistered medical devices designed for treatment, prevention and diagnosis of new coronavirus infection, primarily unregistered test systems.

Thus, the measures taken by the Government of the Russian Federation to prevent the spread of new coronavirus infection in terms of medical devices made it possible to eliminate the shortage of medical devices necessary for provision of proper medical care in the shortest time possible. At the same time, it should be noted that on the territory of the Russian Federation it is necessary to implement a mechanism of putting medical devices into civil circulation, as well as traceability via labelling of medical devices from the manufacturer to the end consumer, which, undoubtedly, must become one of the foremost targets in the near future in order to increase control over quality, effectiveness and safety of medical devices.

References

1. Astapenko E.M., Kortoshkina A.O. Global trends in circulation of medical devices. – Vestnik Roszdravnadzora. – 2019. – Vol. 3. – P. 21–23.