The deadline for the replacement of Medical Devices registration certificates has been extended to 1 January 2021.
In accordance with Resolution No. 1416 of December 27, 2012, such deadline was set to January 1, 2017, but with Resolution No. 160 approved on February 14, 2017, the Roszdravnadzor stretched to 4 years the possibility of replacing the registration certificates of Medical Devices / IVD and kit having the following characteristics:
- unlimited validity;
- issue date prior to January 1, 2013.
In order to proceed with the replacement of the certificate, it is required to appoint an Authorized Representative (for more information see https://www.thema-med.com/en/russia-ad-oggi-effettiva-la-nomina-di-un-rappresentante-autorizzato-in-loco/).
From January 1, 2021 only devices covered by the new certificates will be placed on the market in the Russian territory.
The procedure will take a few months so it is advisable to start the replacement procedure as soon as possible.
Moreover, should be noted that with Resolution No. 1518, approved on January 2017, the Roszdravnadzor has updated and expanded the list of Medical Devices exempt from VAT.
For more information: http://publication.pravo.gov.ru/Document/View/0001201702140017?index=1&rangeSize=1 http://government.ru/docs/7104/
http://www.consultant.ru/document/cons_doc_LAW_210255/c79e551425daa6748a474e16ead9f6c4fc75c4cd/
