RUSTANDARD - Product Registration and Certification
GOST R, Gost Russia, Gost Standard, RTN, GGTN

Russia: mandatory inspection of the medical device production site

16 February 2024

Russia: mandatory inspection of the medical device production siteFrom 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).

 

Ended the transitional period in the GOST national certification

07 November 2023

Ended the transitional period in the GOST national certificationOn 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.

 

Russia temporary simplified product certification procedures

28 March 2022

353Russian 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.

 

Exports to Russia: clarification on GLN and GTIN codes

28 June 2021

GLN RussiaThe requirement of the GLN and GTIN codes was introduced for the first time in the Russian certification field with the order of the Ministry of Economic Development of the Russian Federation of 31.07.2020 No. 478. This order sets out an EAC declarations of conformity registration procedure in the Russian national database. For manufacturers outside the Eurasian Union, in addition to the data usually entered, the obligation to enter GLN and GTIN code was introduced starting from 01.01.2021 (date of entry into force of the aforementioned order).

 

SPS IPC Drives Italia - Parma, May 22 - 24, 2018

08 May 2018

SPS IPC Drives Italia - Parma, May 22 - 24, 2018Rustandard will take part in the SPS IPC Drives exhibition held in Parma (Italia) from 22 to 24 May 2018. The event is dedicated to industrial automation technologies and gathers manufacturers and suppliers of electric equipment and electronic components from all over the world.
All those who are interested in the product certification in the Customs Union will have an occasion to get more information on this subject and the latest news on the evolution of local technical regulations.

 
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