Major Changes to Russian Medical Device Regulations Planned for 2013

Significant changes to how medical devices are regulated in the Russian Federation are slated for early 2013, but final implementation of the new rules remains tentative.

The Russian Ministry of Health has already approved new orders regarding medical device classification, importation and adverse event handling. Also under consideration are medical device vigilance processes, conformity assessments as well as quality and safety issues. All orders under consideration must be approved before authorities begin implementing actual regulations.

Some of the most important changes that may come about include a less direct regulatory role for Roszdravnadsor—final approval decisions will be made by “expert reviewers” rather than the regulator; lack of timelines for medical testing, meaning they could last for years; and inclusion of medical device registration fees into written law.

However, exact implementation timeframes for the new regulations are not yet clear. We will keep you informed of new medical device regulatory developments in Russia as we learn them.

Based on discussions with Russian Ministry of Health and Roszdravnadzor officials, Emergo Group has learned that the following steps to the Russian regulatory process may occur next year:

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.