State control over the circulation of mediacl devices. Results.

MIGEEVA M.A., Deputy Head of the Department for Organization of State Control and Registration of Medical Devices migeevama@roszdravnadzor.gov.ru

1 Federal Service for Surveillance in Healthcare, 4, bld. 1, Slavyanskaya Square, Moscow, 109074, Russian Federation.

Keywords: medical device, State control over the circulation of medical devices, examination of quality, safety of medical devices

For citation: Migeeva M.A. State control over the circulation of medical devices. Results // Vestnik Roszdravnadzora. – 2021. – Vol. 3. – P. 17-20.

The article summarizes the results of State control over the circulation of medical devices during the period of validity of the Decree of the Government of the Russian Federation dated September 25, 2012 № 970 “On approval of the Regulation on state control control over the circulation of medical devices”.

Before July 1, 2021 circulation of medical devices have been regulated by legal norms that are defined in:

  • Federal law dated November 21, 2011 № 323-FZ “On basics of public health care in the Russian Federation” (hereinafter – Law № 323-FZ);
  • The Resolution of the Government of the Russian Federation dated September 25, 2012 № 970 “On approval of Regulation of government control over the circulation of medical devices” (hereinafter – Resolution № 970);
  • The Order of Roszdravnadzor dated December 9, 2019 № 9260 “On approval of Administrative regulations of Federal service for surveillance in healthcare of government control over the circulation of medical devices” (hereinafter – Order № 9260);
  • Code of Administrative offences of the Russian Federation dated December 30, 2001 № 195-FZ, (hereinafter – Code of Administrative offences);
  • Criminal code of the Russian Federation dated June 13, 1996 № 63-FZ (hereinafter – Criminal code).

The 38th article of the Law № 323-FZ defines that medical devices – are any tools, instruments, devises, equipment, materials and other products used for the medical purposes either separately or in combination with each other, or also with other accessories required for the use of those devices as intended, including specific software, and designed by producer for preventive measures, diagnosis, treatment, and medical rehabilitation from diseases, human organism condition monitoring, medical researches, recovery, substitution, change in anatomical formation or physical functions of organism, prevention or termination of pregnancy, which are not functionally used by pharmacological, immune, genetic or metabolic effect on human organism.

The state control over the circulation of medical devices represents one of the ways of inspection in healthcare and includes control over technical, biocompatibility and clinical testings, effectiveness, safety, production, manufacture, utilization, storage, transportation, import to the Russian Federation, export of medical devices from the Russian Federation, as well as state control over assembling, adjustment, usage, operation, including service, repairing, utilization or destruction of the medical devices.

The 95th article of the Law № 323-FZ states that the circulation of medical devices within the Russian Federation is subject to state control.

State control over the circulation of medical devices includes:

  1. inspections of compliance with the regulations in sphere of circulation of medical devices, affirmed by the authorized executive body, by subjects of circulation of medical devices;
  2. issuance of permits for the import of medical devices into the territory of the Russian Federation for the purpose of their state registration;
  3. safety monitoring of medical devices;
  4. evidentiary purchases in order to inspect the compliance with the restriction of realization of falsified medical devices, imperfect medical devices and counterfeit medical devices.
Table 1. The amount of identified defective, falsified, unregistered medical devices for the period from 2014 to 2020
Identification of medical devices in circulation (amount of titles):
Year unregistered defective falsified withdrawal of a producer
2014 624 0 2 56
2015 390 10 6 31
2016 338 135 20 116
2017 337 261 12 226
2018 251 438 20 413
2019 257 443 13 425
2020 169 234 14 293

Defective, falsified, unregistered medical devices have been revealed throughout the previous period (table 1).

Since 2014 Roszdravnadzor has terminated the circulation of approximately 25 million pieces of medical devices that are fail to fulfill the requirements of Russian legislation. Thereby, the potential danger for lives and health of 25 million citizens, who need medical assistance have been avoided.

In 2014 604 titles of unregistered medical devices were revealed as part of the state control over the circulation of medical devices. The results of the state control over the circulation of medical devices proved the need to take measures aimed at stiffening of administrative and criminal liability for the circulation of falsified, defective and unregistered medical devices.

The Federal Law dated December 31, 2014 № 532-FZ that took effect on the January 23, 2015, amended Code of Administrative offences and Criminal code by establishing and stiffening the administrative and criminal liability for the circulation of falsified, defective and unregistered medical devices on the initiative of Federal service for surveillance in healthcare, with the support of Ministry of Health of the Russian Federation (table 2, 3).

Table 2. Administrative liability for the circulation of falsified, defective, unregistered medical devices
Year Administrative liability
records under the article 6.28 of the Code of Administrative offences total sum of imposed fines, million rubles records under the article 6.33 of the Code of Administrative offences total sum of imposed fines, million rubles
2014 624 0 2 56
2015 390 10 6 31
2016 338 135 20 116
2017 337 261 12 226
2018 251 438 20 413
2019 257 443 13 425
2020 169 234 14 293
Table 3. Сriminal liability for the circulation of falsified, defective and unregistered medical devices
Time range (year)/ article 2015 2016 2017 2018 2019 2020

Article 235.1 of the Criminal code

Illegal production of pharmaceuticals and medical devices

reported crimes 0 4 5 7 3 3
completed investigations of the crimes with a referral to the court 0 0 6 4 1 4

Article 238.1 of the Criminal code

The circulation of falsified, defective and unregistered pharmaceuticals, medical devices and biologically active supplements

reported crimes 12 29 101 103 115 122
completed investigations of the crimes with a referral to the court 4 4 32 62 30 28

Article 227.2 of the Criminal code

falsification of documents for pharmaceuticals or medical devices

or for packaging of pharmaceuticals or medical devices

reported crimes 1 0 2 2 1 6
completed investigations of the crimes with a referral to the court 0 0 0 3 1 0

Since 2015 the total sum of imposed fines for administrative offenses in sphere of the circulation of medical devices amounts approximately 166 million rubles.

The interaction with law-enforcement agencies in order to warning, uncovering and suppress the offences of law in sphere of the circulation of medical devices within the state control over the circulation of medical devices. Thuswise, in order to work against the circulation of falsified, counterfeit, defective and unregistered medicines and medical devices an Agreement on coordination arrangements of the Federal service for surveillance in healthcare and the Ministry of Internal Affairs of the Russian Federation was signed in 2015.

Table 4. Typical offences of obligatory requirements specific for different subjects of the medical devices circulation
Subjects of the medical devices circulation Typical, offences of obligatory requirements that are detectable during the oversight actions.
Producers of medical devices
  • production and realization of defective items;
  • production and realization of unregistered medical devices;
  • production of medical devices out of accordance with the technical and (or) operational documentation prepared/designed by the producer;
  • production of medical devices without corresponding license;
  • change in location and in location of manufacturing without notification of Roszdravnadzor and corresponding adaptions to the registration certificate.
Suppliers of medical devices
  • Realization of unregistered and defective medical devices;
  • violation of labeling (absence of name and manual written in Russian language);
  • dissemination of incorrect information on decisions of Roszdravnadzor, unauthorized interpretation of decisions of Roszdravnadzor, failure to report to the territorial bodies of Roszdravnadzor about the detection of medical devices in circulation that do not satisfy the established requirements.
Medical organizations
  • usage of defective and unregistered medical devices;
  • delayed maintenance operation and inspection of medical devices;
  • storage and usage of medical devices with the expired lifetime;
  • failure to report to the territorial bodies of Roszdravnadzor about the detection of medical devices in circulation that do not satisfy the established requirements

The mentioned measures have led to the positive results – the amount of detectable unregistered medical devices has declined in 2015, at the same time, the amount of applications for the official registration of medical devices and adaptions to registration documentation that is contained in  application dossier (also in case of changing of production (manufacture) place address of medical device and in case of changing of the name of medical device, upgrade of its’ parameters and characteristics as its’ purpose of use and (or) functional principle remains the same) has increased by more than 700. The increasing trend of submitted applications for the official registration and adaptions to registration documentation that is contained in application dossier has remained in 2016. If in 2014 there were approximately 4 thousand applications, in 2016 this amount has increased to 7.7 thousand of applications.

Since 2014 Roszdravnadzor records typical offences of obligatory requirements which are specific for different subjects of the circulation of medical devices, while carrying-out the state control over the circulation of medical devices (table 4).

The offences of obligatory requirements can influence the quality and safety of medical device to a different extent. Therefore, that influences the safety and quality of medical assistance.

Results demonstrate the presence of of typical offences throughout the whole period of state control over the circulation of medical devices. The structure of revealed offences remains the same, what confirms the need of quality management system implementation at each stage of medical device circulation.

Summing up the work of the Federal service for surveillance in healthcare in the sphere of state control over the circulation of medical devices the active work of territorial bodies of Roszdravnadzor in constituent entities, subdivisions of the Ministry of Internal Affairs on different levels and other subdivisions of law-enforcement agencies of the Russian Federation are worth noting in work to prevent the circulation of unregistered, imperfect, falsified medical devices.