The Russian Federation has a list of slated changes to its Medical Device Regulations for 2013.  Final implementation of the rules changes is still pending.  The Emergo Group discussed the changes with the Russian Ministry of Health and Roszdravnadzor officials and they listed the following potential changes for 2013:

  1. Applicant must obtain an import permit for samples submitted for testing by Rozsdravnadzor.
  2. Applicant must establish agreements with laboratories for any necessary technical and toxicological testing of its device.
  3. Applicant must submit documentation including test reports to Roszdravnadzor.
  4. Roszdravnadzor authorizes expert review of the applicant’s submission.
  5. Expert reviewers determine whether additional clinical testing of device is necessary and provides list of hospitals where such tests should occur.
  6. Roszdravnadzor informs applicant whether clinical tests are required.
  7. Applicant must set up agreements with hospitals where clinical testing will take place.
  8. Applicant provides clinical testing results to Roszdravnadzor.
  9. Roszdravnadzor then sends applicant’s clinical test results out for expert review.
  10. Expert reviewers notify Roszdravnadzor whether clinical test results are acceptable, provide a report of the test review to regulators, and inform Roszdravnadzor whether the device in question can be registered.
  11. Roszdravnadzor issues either a Registration Certificate to applicant based on a positive expert review or a refusal based on a negative review.

More Information can be found at the Emergo Group Website


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