Three Things You Should Know about Medical Device Regulations in Russia

Dear Colleagues, 

Welcome to my monthly review of medical device regulatory changes in Russia and the Eurasian region:

1. New Procedure for Importation of Samples of Medical Devices into Russia

On 30 September 2020, the Russian Ministry of Health published Regulation 661N (link in Russian) and updated the procedure for obtaining an importation permit and importing samples of medical devices for registration in Russia. 

The new regulation will go into effect in January 2021, and unlike the current procedure described in Regulation 7N, the entire new procedure will be completed only in electronic form.

The importation permit is required for bringing in samples of medical devices for preregistration testing. It will be required for any medical device made by a foreign manufacturer, except medical software. It will be issued free of charge by the regulator Roszdravnadzor within five business days and will be valid for one year.

The Regulation lists the documents required for obtaining an importation permit and the list of reasons for the rejection of a submission.

2. Updated Guidance on VAT Application for Medical Devices in Russia

On 19 October 2020, the Russian Ministry of Finance published letter N0307-07/90841 (link in Russian) and provided guidance on the application of value-added tax (VAT) exemption on the sale of medical devices and its components in Russia.

According to the document, exemption from VAT is applied on the conditions that there are registration certificates for the medical devices and that they are included in the list found in Resolution 1042.

If the components necessary for the intended use are sold together with medical devices and in the amount specified in the delivery set, then these components should be recognised as integral parts of medical devices and exempted from VAT.

3. Criteria for Humanitarian Use of Medical Products in Kazakhstan

On 14 October 2020, the government of Kazakhstan published Resolution 662 (link in Russian) and updated the list of cases when pharmaceutical products or medical devices are allowed to be imported into the country for humanitarian use.

The regulation allows importation – without the approval/registration by the Ministry of Health – of medical products for the prevention and elimination of the consequences of natural and civil emergencies, as well as during the start of a state of emergency; of medical products that are intended for prevention and treatment of especially dangerous infectious diseases; and of orphan (rare) diseases.