FAQ MD regulation roszdravnadzor

VAT rate for medical devices imported to Russia and registered as medical-purpose devices (medical equipment)

With reference to the letter about the application of exemption from value-added tax (the tax rate of 10 per cent) to medical devices imported into the Russian Federation and registered as medical-purpose devices (medical equipment), please be informed of the following.

Under Paragraph 4 of Sub-clause 1, Clause 2, Article 149, and Paragraph 3 of Sub-clause 4, Clause 2, Article 164 of the Tax Code of the Russian Federation (“the Code”), exemption from value-added tax (application of the tax rate of 10 per cent) is granted in respect of medical devices for which a medical device registration certificate is presented or, until 1 January 2017, a medical-purpose device (medical equipment) registration certificate.

As per Federal Law No 25-FZ “On the Introduction of Amendments to Part Two of the Tax Code of the Russian Federation,” dated 7 March 2017 and coming into effect on 1 July 2017, exemption from value-added tax (application of the tax rate of 10 per cent) in respect of medical devices (medical equipment) is granted when tax and customs agencies are shown a medical device registration certificate issued under the Eurasian Economic Union law or, until 31 December 2021, a medical device registration certificate (a medical-purpose device (medical equipment) registration certificate) issued under the Russian Federation law.

At the same time, Resolution No 160 of the Government of the Russian Federation, dated 10 February 2017 and titled “On the Introduction of Amendments to Resolution No 1416 of the Government of the Russian Federation, dated 27 December 2012,” extends the deadline for replacing old registration certificates for medical-purpose devices (medical equipment) until 1 January 2021.

Thus registration certificates for medical-purpose devices and medical equipment without a fixed expiry date issued before the day Resolution No 1416 of the Government of the Russian Federation, dated 27 December 2012, came into effect will remain effective until 1 January 2021.

Considering the above, medical devices registered as medical-purpose devices (medical equipment) imported into the Russian Federation between 1 January 2017 and 30 June 2017, inclusive, will be exempt from value-added tax (the value-added tax rate of 10 per cent will be applied).