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Is it enough for the declarant to have a registration certificate for a medical device requiring maintenance or repair when importing spare parts for medical equipment registered under the rules of the EAEU?

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Enough.

According to subparagraph "d" of paragraph 6 of the Procedure, the condition for the declarant's exemption from confirmation of technical regulation measures when importing spare parts for maintenance and (or) repair of previously imported finished products is the submission to the customs authority of documents on conformity assessment of finished products (including expired ones) requiring maintenance and (or) repair, and (or) information about such documents.

Spare parts can only be imported:

  • by a person authorized by a foreign manufacturer of finished products for maintenance and (or) repair previously imported or imported by the specified person into the customs territoryThe EAEUfinished products;
  • the manufacturer of the EAEU member state or a person authorized by him for the maintenance and (or) repair of finished products previously produced and put into circulation, for which compliance with mandatory requirements has been confirmed.

In accordance with paragraph 3 of the Rules for Registration and Examination of Safety, Quality and Effectiveness of Medical Devices approved by the Decision of the CouncilECENo. 46 of 12.02.2016, registration certificate is a document of a single form confirming the fact of registration of a medical device, that is, the fact of passing the procedure for issuing a permit by the authorized body for the medical use of a medical device within the EAEU.

Thus, such a document is a document confirming the compliance of a medical device with safety requirements, and can be applied as a document on the conformity assessment of a finished medical device.

Published 11 months agofrom 
#47