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13 May 2025 |
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 From 01/03/2025, the registration of medical devices in Russia is regulated by Legislative Decree RUS Gov. No. 1684 of 30/11/2024. The new regulation requires foreign manufacturers holding a medical device registration certificate, better known as RZN certificate, to appoint an Authorized Representative in Russia or to update the data on the same in case of appointment of a new representative. The communication must be made by 31/08/2025 under penalty of revocation of the registration certificate.
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24 January 2025 |
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 Since 2019 in the EAC area (Russia, Belarus, Kazakhstan, Kyrgyzstan, Armenia) and since 2021 in Uzbekistan (CIS) there has been an obligation to trace products placed on the local market by affixing an electronic mark (a QR code and more precisely a code called Data Matrix) on each individual product. This is a traceability that reaches down to the single unit and not just the batch. Traceability is currently required for the following product categories.
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16 February 2024 |
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 From 01/01/2024, the mandatory inspection of the production site is introduced for manufacturers of medical devices belonging to risk class IIa (sterile), IIb and III, consisting of a verification of the quality management system documentation and an inspection of the medical device production plant. The inspection service will be provided on a contractual basis by one of the two public bodies controlled by Roszdravnadzor (Medical Devices Market Surveillance Authority).
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07 November 2023 |
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 On 31/08/2023, following the updating of the list of products subject to mandatory certification on Russian territory and the revision of the technical standards, the transitional period within which it was possible to import and distribute products without product certification on the Russian market ended. We remind you that this type of certification (commonly known as GOST R certification) still exists in the Russian Federation, although it is destined to be gradually replaced by the EAC certification of the Eurasian Community.
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28 March 2022 |
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 Russian Government temporarily simplified product certification procedures and automatically extended the validity of certificates and declarations of conformity to support the domestic economy within the sanctions context by adopting Decree No. 353 of 12/03/2022. Certification bodies were given the opportunity to postpone the factory periodic inspection or conduct it remotely by video conferencing services. The control and supervision activities of Russian National Accreditation Body to suspend or invalidate certificates and declarations of conformity have been temporarily suspended.
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