Oct 12, 2021

The Eurasian Economic Union (EAEU), which  includes Russia, Armenia, Belarus, Kazakhstan and Kyrgyzstan, has amended requirements and timeframes for medical device registration and compliance across its economic area.

A recent order (link in Russian) revises rules for registration as well as inspection of medical devices sold within the EAEU:

  • Steps in the EAEU device registration process are clarified;
  • Clearer criteria are provided for grouping families of several device models under single registration certificates;
  • Timeframes are clarified and adjusted for various registration and compliance processes and procedures.

The new order replaces rules established in early 2016 , but must be ratified by all five EAEU member countries before taking full effect.

Additional Russian and EAEU medical device regulatory resources:

Author

  • Stewart Eisenhart

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