The circulation of medical devices in Russia is regulated as strictly as pharmaceuticals. From a legal perspective, a medical device can enter circulation only after undergoing state registration. This is stipulated in Part 4 of Article 38 of Federal Law No. 323-FZ: only those medical devices that have a valid registration certificate are allowed to circulate in the territory of the Russian Federation. Without it, the device is not considered market-approved, and it cannot be manufactured, imported, sold, or used in medical practice. The law interprets the lack of registration as a violation that poses a potential threat to patient safety.
However, there is a strictly limited list of exceptions: devices for personal use as prescribed by a doctor, demonstration of samples at exhibitions, use in scientific research, humanitarian aid, and special regimes in innovative medical clusters. Starting from March 1, 2025, the registration procedure will be regulated by Decree of the Government of the Russian Federation No. 1684. However, this does not apply to commercial circulation, as selling unregistered devices is prohibited under any circumstances.
State registration in Russia and the EAEU involves verification of the device’s technical characteristics, compliance with regulatory requirements, test results, and clinical assessment. The authorized body is Roszdravnadzor. It analyzes the submitted materials, evaluates the safety and quality of the device, and, if compliant, issues a registration certificate. In 2025, registration can be conducted either through the national procedure or according to the unified rules of the Eurasian Economic Union. However, regardless of the chosen path, state registration remains the only legal way to bring a medical device to market.
For manufacturers, registration is a key milestone of responsibility. The manufacturer must ensure the completeness of technical documentation, conduct necessary tests, prepare operational materials, bring the device to market in accordance with declared characteristics, and subsequently monitor its safety under real-world conditions. Foreign manufacturers are obliged to appoint an authorized representative in the Russian Federation, as they are responsible to the regulator for the circulation of the device and communicate with надзорные органы in case of identified issues. At the same time, distributors, importers, and sellers also bear direct responsibility. Import of medical devices is possible only with a registration certificate, and the importer must notify Roszdravnadzor. Warehouses and retail outlets are allowed to store and sell only those devices whose registration status is confirmed. If the registration certificate is canceled or revoked, the circulation of the device must be immediately stopped.
Violation of registration requirements entails administrative, civil, and criminal liability. Administrative sanctions are provided for in Articles 6.28 and 6.33 of the Code of Administrative Offenses of the Russian Federation. Thus, violation of established rules in the field of medical device circulation entails an administrative fine for citizens in the amount of two to four thousand rubles, for officials — five to ten thousand rubles, and for legal entities — thirty to fifty thousand rubles. In the first case, these are relatively small fines for violation of medical device circulation rules. In the second, significantly more serious measures: large fines for organizations, suspension of activities, and separate enhanced sanctions for online sales. The use of online channels is considered by the regulator as a way to widely distribute potentially dangerous products.
Civil consequences arise if an unregistered device causes harm to a patient’s health. In this case, the seller and manufacturer are held liable under the Consumer Protection Law and are obliged to compensate for harm in full, regardless of the contract and supply conditions. The buyer can also demand a refund, contract termination, or compensation for damages. The lack of registration is recognized as a significant defect of the product, which automatically makes the transaction vulnerable from both civil and administrative law perspectives.
In some cases, criminal liability arises. Article 238.1 of the Criminal Code of the Russian Federation provides for punishment for illegal production, import, or sale of unregistered medical devices if the circulation is carried out on a large scale or leads to serious harm to patients’ health. Sanctions include imprisonment for up to 12 years. This article is applied when the violation ceases to be formal and becomes a threat to life and health. In practice, criminal cases are initiated based on facts of supply of unregistered devices to hospitals, sale of unregistered devices on a large scale, and cases of forged registration documents. Roszdravnadzor plays a key role in identifying such violations. The service conducts inspections, seizes illegal products, suspends operation of dangerous devices, and transfers materials to law enforcement agencies. Annually, the agency, together with the Ministry of Internal Affairs, detects millions of units of illegal products. Each such case shows that even if a device seems «simple», for example, consumables, ultrasound paper, or individual instruments, its circulation without registration is considered a violation of the same level as the circulation of complex medical equipment.
