The official website of the Federal Service for Surveillance in Healthcare on September 28, 2020 contains information on the launch of the electronic service “Import of unregistered medical devices”.
The Arbitration Court of the Moscow District, in its Award No. F05-15092/2020 of 06.10.2020 No. F05-15092/2020 rejected the state customer's claim to provide a registration certificate of a medical device for the delivered car and mammography device.
New Rules for the destruction of seized counterfeit medicines, substandard and counterfeit medicines (hereinafter – Rules for the destruction of medicinal products) were approved by the Decree of the Government of Russia dated September 15, 2020 No. 1447.
By letter of the Federal Antimonopoly Service dated September 28, 2020 No. IA/83689/20, clarifications were given on the procurement of disposable medical devices (use) made of polyvinyl chloride plastics.
Decree of the Government of Russia dated October 1, 2020 No. 1583 approved the Rules for the circulation of generic drugs and biosimilars until the end of the period established for conducting studies of their bioequivalence or therapeutic equivalence (hereinafter – the Rules), which entered into force on October 5, 2020.
- The Government of Russia determined new rules for the formation of wholesale and retail markups to prices for vital and essential drugs
- The regulation for issuing permits for the online sale of medicinal products came into force
- A new procedure for determining the initial procurement price of medical devices came into force
- A number of legal acts in the field of circulation of medical devices fell under the regulatory guillotine
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