This document summarizes the mandatory information that must be included on medical device labels in Russia. The label must include: 1. The name of the medical device in Russian. 2. Information about the manufacturer including the word "manufacturer" in Russian, the name and address of the manufacturer in the original language, and the country of origin in Russian. 3. The registration number and date of registration for the device in Russia. 4. Information about the device's properties in Russian such as size, sterility, single-use instructions, storage conditions, and shelf life.

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