Resolution of the Government of the Russian Federation No. 1440 dated September 15, 2020, approved the Rules for the Destruction of Seized Falsified, Substandard, and Counterfeit Medical Devices (hereinafter the "Rules for the Destruction of Seized Medical Devices" or the "Rules"). The document enters into force on January 1, 2021, and shall remain effective until January 1, 2027.

Under the Rules, medical devices constituting physical evidence in criminal cases and/or administrative offense cases are subject to destruction pursuant to the procedures established by criminal procedure and administrative offense legislation. Authorized entities shall destroy seized medical devices placed under a customs procedure in accordance with the customs legislation of the Russian Federation and the regulations of the Eurasian Economic Union (EAEU).

As a matter of reference, under the procedure for the sale or destruction of items constituting physical evidence whose storage pending the conclusion of a criminal case or during criminal proceedings is impracticable—approved by Resolution of the Government of the Russian Federation No. 848 dated August 23, 2012—the Federal Agency for State Property Management (Rosimushchestvo) executes such destruction. Furthermore, pursuant to the Instruction on the Procedure for the Storage of Seized Goods and Documents Relevant as Evidence in Administrative Offense Cases—approved by Order of the Federal Customs Service No. 1339 dated December 18, 2006—the relevant authorities must return seized items and documents to the owner upon dismissal of the administrative offense case or if the penalty imposed by the internal affairs agency does not involve confiscation or compulsory acquisition for value.

The Rules establish that counterfeit medical devices shall be withdrawn from circulation and subsequently destroyed pursuant to a court order.

Falsified and substandard medical devices are subject to destruction based on either a court order or a decision issued by the Federal Service for Surveillance in Healthcare (Roszdravnadzor) following state control over the circulation of medical devices.

The owner of the seized medical devices must receive the court order or Roszdravnadzor's decision on destruction within 5 business days from the date the court order enters into legal force, or within 10 business days from the date Roszdravnadzor adopts the destruction decision. The authority may transmit this decision via registered mail with return receipt requested or as an electronic document signed with an electronic signature.

The owner may object to the decision within 30 business days from the date of service of the destruction decision by filing an administrative appeal, which the reviewing authority must consider within 30 days from the date of submission.

Upon acceptance of the decision, the order becomes enforceable. The owner of the seized medical devices shall bear all costs associated with their destruction.

The parties shall document the destruction of medical devices by drawing up a certificate of destruction of seized medical devices executed in three counterparts. The owner of the seized medical devices shall retain the first counterpart; the second counterpart shall remain with the organization or sole proprietor that executed the destruction; and the owner must submit the third counterpart to Roszdravnadzor within 5 business days from the date of destruction.

If the responsible party fails to execute the destruction decision, Roszdravnadzor shall petition the court for an enforcement order to compel compliance.

Authorized entities must destroy seized medical devices in compliance with environmental protection laws, healthcare regulations, and legislation governing public sanitary and epidemiological welfare.