Decree of the Government of Russia dated September 15, 2020 No. 1440 approved the Rules for the destruction of seized falsified medical devices, substandard medical devices and counterfeit medical devices (hereinafter referred to as the Rules for the destruction of seized medical devices, the Rules). The document comes into force on January 1, 2021 and will be valid until January 1, 2027.
According to the Rules, medical devices that are material evidence in criminal cases and (or) in cases of administrative offenses are subject to destruction in the manner prescribed by the criminal procedure and legislation on administrative offenses. The seized medical devices placed under the customs procedure are destroyed in accordance with the customs legislation of the Russian Federation and the legislation of the EAEU.
Recall that in accordance with the procedure for the sale or destruction of items that are material evidence, the storage of which until the end of a criminal case or in a criminal case is difficult, approved by Decree of the Government of the Russian Federation No. 848 dated 23.08.2012, destruction is carried out by the Federal Agency for State Property Management. According to the Instruction on the procedure for storing seized items and documents that have the value of evidence in cases of administrative offenses, approved by the Decree of the Federal Customs Service of December 18, 2006 No. 1339, upon termination of an administrative offense case or appointment to a person in respect of whom the internal affairs body carried out proceedings on the case on an administrative offense, punishment not related to confiscation or compensation, the seized things and documents are subject to return to the owner.
The Rules stipulate that counterfeit medical devices are subject to withdrawal from circulation and subsequent destruction on the basis of a court decision.
Falsified and substandard medical devices are subject to destruction on the basis of a court decision or on the basis of a decision of the Federal Service for Surveillance in Healthcare, adopted based on the results of state control over the circulation of medical devices.
A court decision or a decision of the Federal Service for Surveillance in Healthcare on the destruction of seized medical devices is sent to the owner of the seized medical devices within a period not exceeding 5 working days from the date the court decision enters into legal force, or within a period not exceeding 10 working days from the date of adoption of a decision on the destruction of seized medical devices. In this case, such a decision can be sent by registered mail with acknowledgment of receipt or in the form of an electronic document signed with an electronic signature.
The owner can report disagreement with the specified decision within 30 working days from the date of delivery of the decision on destruction by filing a complaint, subject to consideration within 30 days from the date of filing.
If you agree with the decision, it is subject to execution. The costs associated with the destruction of the seized medical devices are reimbursed by the owner of the seized medical devices.
Destruction of medical devices is documented by an act on the destruction of seized medical devices, the preparation of which is carried out in 3 copies. One copy is kept by the owner of the seized medical devices, the second is kept by the organization or individual entrepreneur who carried out the destruction, the third copy is submitted by the owner to the Federal Service for Surveillance in Healthcare within 5 working days from the date of destruction.
If the decision on destruction has not been executed, the Federal Service for Surveillance in Healthcare applies to the court with a demand to enforce the said decision.
The destruction of seized medical devices is carried out in compliance with the requirements of the legislation in the field of environmental protection, legislation in the field of health protection, as well as legislation in the field of ensuring the sanitary and epidemiological well-being of the population.