Counterfeit Medical Devices

2023:700 thousand fake medical gowns worth 70 million rubles were found in Perm

In the Perm Territory, the prosecutor's office approved the indictment in a criminal case against a group of persons accused of producing and selling falsified medical devices and fraud. The press service of the supervisory authority announced this on April 10, 2023. Read more here.

2022

Roszdravnadzor revealed fake and defective medical devices worth 535 million rubles

At the end of 2022, the Federal Service for Supervision of Healthcare (Roszdravnadzor) identified more than 400 thousand fake, poor-quality or unregistered medical devices totaling 535 million rubles. This is stated in the report, which the department published in April 2023.

In most cases, representatives of Roszdravnadzor identified fakes, of which 296 thousand copies were found in 2022. The second and third places in the list under consideration were taken by poor-quality and not passed the mandatory registration of medical devices - 100 thousand and 42 thousand units were discovered in 2022, respectively. According to official information, all indicated violations were recorded within the framework of 400 inspections, which were carried out with the cooperation of Roszdravnadzor with the Ministry of Internal Affairs, the Investigative Committee, as well as the prosecutor's office and the FSB.

Roszdravnadzor revealed more than 400 thousand fake, poor-quality or unregistered medical devices

It is reported that in just 2022, Roszdravnadzor received 1,176 reports about the adverse consequences of the use of medical devices. At the same time, in 8 cases it was about deaths, and in 136 - about the threat to the health and life of patients. 1020 appeals to Roszdravnadzor, that is, most of them in 2022 were related to imported medical devices. In 156 cases, it was about the products of domestic manufacturers.

According to the materials of Roszdravnadzor, in 2022, more than 3 thousand medical devices were registered for the first time in the Russian Federation. In parallel with this, 3.3 thousand dossiers were amended. In 2022, violations were identified in 608 medical institutions. At the same time, during the inspections, 514 protocols were drawn up in the amount of 4.7 million rubles. Joint inspections of Roszdravnadzor with law enforcement agencies in this direction showed that illegal drugs totaling 7.8 million rubles were stored in hospitals and other medical institutions.^[1]

Mishustin approved the rules for the seizure and destruction of falsified and poor-quality medical devices

In February 2022, Prime Minister Mikhail Mishustin signed a decree approving new rules for the withdrawal from circulation and destruction of falsified medical devices, poor-quality medical devices and counterfeit medical devices. The document will enter into force on September 1, 2022 and will be valid for six years.

The key innovation in the rules is the procedure for Roszdravnadzor to seize falsified and poor-quality medical devices. The rules establish the procedure for the owner to make an independent decision on the withdrawal from circulation of relevant medical products. The destruction of falsified or poor-quality medical devices is entrusted to their owner, subject to compliance with the requirements of legislation on health and environmental protection.

Mikhail Mishustin approved the rules for the seizure and destruction of falsified and poor-quality medical devices

According to the authors of the initiative, the adopted resolution will increase the effectiveness of the existing mechanisms for the implementation of federal state control over the circulation of medical devices, increase the level of coordination of the supervisory authority - Roszdravnadzor - with manufacturers or authorized representatives of manufacturers of medical devices, sellers and suppliers of medical devices or persons performing the functions of a foreign manufacturer.

The implementation of the resolution will allow participants in the circulation of medical devices to minimize the financial risks associated with the identification of medical devices in circulation in violation of the law.

The decision of Roszdravnadzor can be appealed by the manufacturer or owner, whose medical device was found to be falsified or poor quality.

The new rules will replace the 2020 document on the destruction of seized falsified, poor-quality and counterfeit medical products.^[2]"

2021: Russia adopted a law on the operational seizure of poor-quality medical devices

On June 9, 2021, the State Duma adopted in the third (final) reading a bill on the operational withdrawal of poor-quality medical devices. The changes will be spelled out in the law "On the basics of protecting the health of citizens in the Russian Federation."

The document obliges owners of falsified, poor-quality or counterfeit medical devices to bear the costs associated not only with the destruction of such medical devices, as happened before, but also with their prompt withdrawal from circulation.

The Duma adopted a law on the operational seizure of falsified medical devices

Poor-quality and falsified medical devices can be withdrawn from circulation and destroyed on the basis of a decision by their owner, Roszdravnadzor or a court decision. Counterfeit medical products will be subject to seizure and destruction only by a court decision.

The new regulations also oblige owners of falsified, poor-quality or counterfeit medical devices to reimburse the costs associated with the withdrawal of such medical devices from circulation.

Before the adoption of these amendments, the legislation of the Russian Federation did not determine the procedure for the seizure of medical counterfeit by Roszdravnadzor. In this regard, the document proposes to establish mandatory requirements, the assessment of compliance with which is carried out within the framework of state control over the circulation of medical products.

These measures, according to the developers of the bill, will allow participants in the appeal of medical devices to minimize the financial risks associated with the identification of medical devices in circulation in violation of the law. 

The Government of the Russian Federation will have to approve the procedure for the seizure of medical products in circulation in violation of the law.

The Ministry of Health of the Russian Federation has developed amendments to federal law on behalf of Deputy Prime Minister Tatyana Golikova. It was assumed that Roszdravnadzor would receive the authority to recover through the court compensation for the costs of withdrawing and storing poor-quality or falsified medical devices.^[3]

2020: Reduction of fines issued by Roszdravnadzor for defective and gray medical devices by 13 times, to 6.5 million rubles

The fines issued by Roszdravnadzor for defective and gray medical devices by the end of 2020 decreased by more than 13 times and amounted to 6.5 million rubles. In 2019, the total amount of penalties for the supply of unregistered and substandard products was measured at 87 million rubles.

According to the "City News Agency" Moscow"with reference to the deputy head of the department for organizing state control and registration of medical devices of Roszdravnadzor Maria Migeeva, according to the results of control and supervisory measures in the field of circulation of medical devices in 2020, 1,184 orders were issued to legal entities to eliminate the identified violations, 769 protocols were drawn up on administrative offenses under Art. 6.28 (violation of the established rules in the field of circulation of medical products) and 6.33 of the Administrative Code (circulation of poor-quality, falsified, counterfeit or unregistered medical products).

Fines issued by Roszdravnadzor for defective and gray medical devices for 2020 decreased by 13 times

According to Roszdravnadzor, a total of 1,183 inspections of legal entities were carried out in 2020, including 99 planned and 1,084 unscheduled.

In Moscow and the Moscow region, during inspections at the end of 2020, 62 companies were found to have 29 items of expired medical products, one poor quality and 10 unregistered. For control, 184 types of medical devices were selected with a total volume of more than 4.7 thousand units.

In particular, unregistered medical devices were identified at the Dental Revue 2020 exhibition, expired Phase-5NR ventilators were identified during joint actions with the Office of Economic Security to Counter Corruption of the Ministry of Internal Affairs of the Russian Federation at one of the warehouses in Ramensky, Moscow Region. In addition, a factory for the production of counterfeit personal protective equipment was closed in the Samara region.^[4]

2019: A batch of dental implants worth 3.1 million rubles detained at Sheremetyevo

At the end of March 2019, customs officers at Sheremetyevo airport detained a passenger who was trying to transfer more than 2 thousand undeclared dental products from Seoul.

As a result of the customs inspection, 2 thousand 219 dental items were found: scanner markers and analogues of implants, the press service of the department told the Moscow agency.

Employees of the Sheremetyevo customs stopped an attempt to import more than 2 thousand undeclared dental products from Korea into the Russian Federation

When conducting a fluoroscopy of luggage presented by a 32-year-old South Korean citizen, the inspector drew attention to a large number of homogeneous metal objects.

The young man, from whom undeclared objects were seized, stated that these products are demonstration and intended for exhibition. Men estimated the goods at less than $200, however, according to the customs service, the cost of the cargo exceeds 3.1 million rubles.

Since medical products are included in a single list of products, the movement of which through the customs border of the EAEU is carried out with a declaration of compliance, employees of the department issued protocols under Part 1 of Art. 16.2 of the Code of Administrative Offenses ("Non-declaration of goods subject to declaration according to the established form") and Art. 16.3 ("Non-compliance with prohibitions and restrictions").

Vademec notes that attempts to transfer undeclared medical products from Seoul have previously been thwarted at Sheremetyevo Airport. In July 2017, customs officers stopped an attempt by a 45-year-old South Korean citizen to import 1030 mezzanines (cosmetic injection products) into Russia for a total amount of more than 2 million rubles.

According to the World Health Organization, a tenth of medical products that are in circulation are either falsified or poor-quality (data at the beginning of 2019).^[5]

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