Three Things You Should Know About Medical Device Regulations in Russia and the Eurasian Union, October 2021

Dear Colleagues, 

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

1. New rules for Russian state register of medical devices

On 30 September 2021, the Russian government released Resolution 1650 (link in Russian), ‘On approval of the Rules for maintaining the state register of medical devices’, which, since 1 March 2022, implements new requirements for the Russian state register (the database of approved medical devices).

According to the published regulation, in addition to the information, which is currently available in the database, the updated state register will contain registered instructions for use, photos of the device or software interface as well as information on analogue (substitutable) medical devices.

2. Prolongation of the accelerated registration routes for medical devices intended for diagnosis and treatment of COVID-19

On 28 October 2021, the Russian Ministry of Health released draft amendments (link in Russian) to Resolution 430, which suggested prolonging, from 1 January 2022 to 1 January 2025, the validity of registration certificates for particular batch/lots if the medical devices and in vitro products were intended for diagnosis and treatment of COVID-19. Such certificates were issued according to the accelerated registration procedure. For such a prolongation of the licenses, the registration holder has to submit documents for the procedure of administrative replacement by 1 January 2022.

It should be noted that, for the end of October 2021, there are more than 600 registration certificates in the national database that were issued according to this route and potentially may be prolonged.

The same published draft document extends the possibility of submitting new batches of medical devices for the accelerated registration procedure to 1 January 2025 (instead of 1 January 2022), regardless of the approaching transition to the Eurasian medical device registration system.

In addition, the published regulation expanded, from 360 to 470, the list of medical device products intended for emergency use in the prevention and treatment of coronavirus infection, which fall under the simplified accelerated registration process.

3. New state fees for registration of medical devices in Russia and the Eurasian Union

At the end of September 2021, the Russian government released a draft amendment to the Russian tax code (link in Russian) suggesting an increase in the level of state fees for registration of pharmaceutical products and medical devices in Russia and the Eurasian Union, as of the beginning of 2022.

According to the document, the new amount for registration expertise will vary, depending on the risk class of the medical device, from 72,000 to 184,000 rubles (app. 1,000–2,500 USD). The level of expertise required for amendment of the registration certificates will incur a cost also, from 32,000 to 104,000 rubles (app. 500–1,500 USD).

The fees for the new procedure for getting authorisation for use for certain non-registered in vitro products is expected to be 65,800 rubles (app. 1,000 USD).

According to the published draft regulation, the same level of fees will apply for the expertise and acceptance procedures for Eurasian medical device registration.