From January 2021 new requirements have come into force to obtain the EAC Certificate (EurAseC Conformity), which is essential for commercializing products in Russia.
The new procedure is valid both for EAC (TR CUs) and Russian National approval documents (GOST R, National Fire Safety Certificates, etc.) registered in Russia. The EAC certificates registration procedure in other Eurasian Economic Community countries (Belarus, Kazakhstan, Armenia, Kyrgyzstan) remains as it was.
According to the new procedures, in order to obtain the EAC Certificate the applicant must provide various information, detailed below.
What is the EAC Certificate of conformity?
The EAC Certificate of conformity confirms that devices comply with the Technical Regulations of the Eurasian Economic Community (EURASEC).
Products that bear the EAC Mark have all passed the conformity assessment procedures in one of the Member States of the Eurasian Economic Community and they also comply with the technical requirements. Therefore, they can circulate freely within the Customs Area without further restrictions or constraints.
The Eurasian Economic Community includes Russia, Belarus, Kazakhstan, Armenia and Kyrgyzstan.
What does the EAC Certificate Registration Procedure involve starting from 2021?
From 1 January 2021 the registration number of the customs declaration of the cargo is required in order to move goods beyond customs. Note that the customs registration number is assigned when the custom declaration is accepted, that is, when the applicant expresses the intention to place the goods under a certain customs procedure.
From 1 August 2021 in order to register the EAC Certificate, the applicant must provide the following information:
- Name and address of the Manufacturer, with mention of GLN (Global Location Number), that is the unique code that identifies the company, for products manufactured outside the Customs Union;
- The GTIN (Global Trade Item Number), that is the product code that identifies the goods, mentioned also in the product information section;
- Data on annual inspections.
Because of the implementation of these new procedures, it is probable to have delays in the registration of EAC certificates.
Possible further normative amendments on Medical Devices in Russia
In April 2021, the Russian Parliament discussed several amendments made to the Federal Law No. 323 “On health care protection”, related to the regulation of Medical Devices.
The aforementioned amendments have been approved and are part of a published draft law that has not entered into force yet.
Moreover, a proposal from the Russian government was recently discussed regarding the draft regulation that proposes the simplification of the national registration process (a faster one-step registration) for Russian Manufacturers on the condition that the performance type test, supervised by the Russian healthcare regulator Roszdravnadzor, is performed in the testing laboratory of the expert body.
Finally, within the end of May 2021 another amendment should be discussed regarding Quality Management Systems for Medical Devices Manufacturers. According to the draft document, the quality management audit could be performed remotely, as long as there is a standard audit within 2 years from the virtual inspection.
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