The ban on the export of samples and medical devices

"On Amendments to Certain Acts of the Government of the Russian Federation" came into force .

In accordance with this document, Russian Government Resolution No. 311 of March 9, 2022, "On measures to implement Decree of the President of the Russian Federation No. 100 of March 8, 2022" (RF PP No. 311) has been extended until December 31, 2027, meaning that certain goods are prohibited from being exported from the Russian Federation for another two years. A two-year extension was also initiated in 2023.

Currently, in order to obtain permission from Russian customs authorities to export a medical device imported for the purpose of state registration, it is necessary to obtain a conclusion from Roszdravnadzor regarding the possibility or impossibility of state registration of the medical device.

Unfortunately, a separate export permit issued by Roszdravnadzor does not grant the right to export a previously imported sample of a medical device, since it does not meet the requirements of RF Government Resolution No. 311, paragraph 2, regarding the non-applicability of this resolution "to samples of medical devices previously imported into the territory of the Russian Federation for the purposes of state registration, subject to confirmation by the Federal Service for Surveillance in Healthcare of the fact of import of these goods for the specified purposes (based on copies of documents submitted to the Federal Service for Surveillance in Healthcare confirming the results of tests (research) of the medical device conducted in the territory of the Russian Federation for the purposes of state registration) in the manner established by it."

Please note that the list of medical devices prohibited from export from the Russian Federation is quite extensive, so it is necessary to check the possibility/impossibility of export for each individual medical device.

Please also take into account that it is necessary to check not only the possibility of export from the Russian Federation, but also the possibility of importing a medical device that has been in use during testing into the country of manufacture, since, for example, based on the register “Catalogue of used electromechanical products prohibited for import” from Announcement No. 106 of 2018 of the Ministry of Trade and the Main Customs Administration of products with HS Code 9018 "Used medical, surgical, dental or veterinary instruments and apparatus (including scintigraphic apparatus, other electromedical apparatus and apparatus for examining the eye)" is prohibited from being imported into China.