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Main  >  News  >  The term for re-registration of medical devices according to the rules of the EAEU can be extended until 2026

The term for re-registration of medical devices according to the rules of the EAEU can be extended until 2026

08/09/2019 | EAEU, medical devices

The Eurasian Economic Commission of the Eurasian-Asian Economic Union (EAEU) intends to extend the transition period for re-registration of medical devices with a registration certificate in their country until December 31, 2026. Until December 31, 2021, the manufacturer or authorized person will retain the right to choose - it will be possible to register MDs both according to the rules of the EAEU and according to national rules.

At the same time, the medical device registered according to the rules of the EAEU member will receive the right to circulate on the national market before the expiration of the registration period (or indefinitely, if this is stipulated by the RU) with the right to amend the registration certificate.

According to the current legislation, all medical devices of the EAEU member countries that were registered according to the rules of their country must undergo a new registration procedure according to the EAEU standards before December 31, 2021. MD of those manufacturers who do not have time to do this will be outlawed, and their circulation will be prohibited.

The decision to extend the re-registration deadline should be taken on September 3.

In September 2018, the Association of Medical Device Manufacturers - the Medical Resources Union (Soyuzmedresurs) called on market players to support the extension of the transitional period for re-registration of medical devices, in accordance with the EAEU protocol, until the end of 2031.

The Association appealed to the statistics of issuing registration certificates by Roszdravnadzor (in 2013 1,145 certificates were issued, in 2014 - 720, in 2015 - 1,052, 1,465 medical devices were registered in 2016, only 1,403 were registered in 2017), taking into account the average registration term in 1.5-2 years. According to experts, it would have taken more than 20 years to complete the renewal of the identity cards circulating in the medical device market.

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