The government approved the expansion of the powers of Roszdravnadzor to confiscate medical devices
The Government of the Russian Federation approved amendments to 323-FZ “On the Fundamentals of Health Protection of Citizens in the Russian Federation”, which regulate the right of Roszdravnadzor to make decisions on the seizure of falsified, low-quality medical devices and their destruction, as well as to file claims for enforcement of such decisions. The profile bill will be submitted to the State Duma for consideration.
The bill involves the introduction of amendments to Art. 38 and Art. 86 323-FZ concerning the circulation of medical devices and the powers of Roszdravnadzor. In particular, the law will include the obligation of the owners of counterfeit, substandard or counterfeit medical devices to pay the costs of removing substandard products from circulation, and not just for their destruction.
In turn, the regulator will have the right to apply to the court with claims for the enforcement of decisions on the seizure of falsified, low-quality medical devices and their destruction.
If the amendments are approved, the Government of the Russian Federation will approve the procedure for the seizure by Roszdravnadzor of substandard medical products that do not pass as material evidence in criminal or administrative cases.
As stated in the explanatory note, the amendments are being made to ensure “prompt seizure of counterfeit, substandard, falsified products of the medical industry, including from healthcare institutions, at the expense of violators.”
The Ministry of Health of the Russian Federation developed amendments to 323-FZ in March 2019 on behalf of Deputy Prime Minister Tatyana Golikova. Then it was assumed that Roszdravnadzor would receive the authority to collect through the court compensation for the costs of seizing and storing substandard or falsified medical devices.
In July 2020, the department presented the Procedure for the destruction of falsified, substandard and counterfeit medical products seized in the course of detecting violations during their circulation. In accordance with the document, such medical devices will be subject to destruction either by a court decision or by a decision of Roszdravnadzor or its territorial bodies.
In accordance with the current version of the law, counterfeit and substandard medical devices are subject to seizure and subsequent destruction or export from the territory of Russia, and counterfeit ones – to seizure and destruction. Removal of medical devices from the country must be carried out by the company that imported them, and the owner of the medical devices must compensate for the costs of destruction.