The Ministry of health of the Russian Federation and Roszdravnadzor are considering expanding the list of medical devices subject to preferential regulation in accordance with Resolution No. 430 of April 3, 2020, to 363 positions. In addition, agencies are discussing the opportunity ti simplify mechanisms for registering low-risk medical devices on a permanent basis.

The changes will affect not only the list of medical products, but also the order of treatment, expanding the form and functionality of medical products for the treatment and prevention of coronavirus infection.

At the level of the Eurasian economic Commission, there is a discussion on the notification nature of registration of MI hazard classes 1 and 2A. “If the countries come to an agreement on what it will look like, there will be a fix for fast track for a large number of products that belong to a low risk class»

In early April 20,20, Prime Minister signed resolution No. 430, introducing a preferential treatment of medical products during the pandemic. The simplified registration procedure includes ventilators, oxygenators, artificial blood circulation systems, thermometers, as well as various test systems for SARS-Cov-2, including diagnostic systems for antibodies to a new type of coronavirus.

For single-use medical products-gloves, medical masks, dressing gowns, respirators, Shoe covers – it is allowed to enter into circulation and use without registration in Russia if there is a registration document in the country of origin. In this case, the supplier must, within 3 working days from the date of import of unregistered medical devices, send to Roszdravnadzor information about the series and batches, quantity, factory number, production date, expiration date and storage address of imported medical devices. If they are not used by December 31, 2020, then the devices imported under preferential rules will be destroyed by the beginning of 2021.

News taken from www.vademec.ru