Russian medical device labeling requirements.

1. Регистрационное удостоверение: ФСЗ XXXXот DD.MM.YYYY
Производитель:Healthcare Inc. 12-35 BoylstonAveSeattleWA98102 USA. Сделанов США
Размер 23Gx1, Стерильно, Не применять при повреждении упаковки. Хранить в сухом месте, избегать воздействия прямых солнечных лучей, использовать до: DD.MM.YYYY
Игла инъекционная безопасная
1. Name of the medical device:
(Name of item).Wording must be the same as written in the Russian registration certificate.
2. Information about manufacturer:
•Word "manufacturer“ (Russian lang.)
•Name and address ofthe manufacturer (Original lang.)
•Country of Origin(Russian lang.)
3. Information about registration: Number of the certificate and date of registration in Russia.
4. Information about main "consumer properties”: Current regulations are not clear, what exactly "consumer properties" are. In this section it is recommended to provide information about: -size, -sterility, -single use (if applicable), -cautions (if any), -storage conditions and shelf life.
All information must be provided in Russian. Symbols are not accepted.
5. RST (GOST) symbol: If labeled item is a matter of conformity assessment in Russia (absolute majority of medical devices).
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What information is mandatory on medical device label?
Device and manufacturer on label are fictional; Slide prepared by Alexey Stepanovfor www.medicaldevicesinrussia.comSeptember, 2014