According to information from the Roszdravnadzor, the Russian healthcare agency, new regulations for medical devices are currently being implemented in the country. Some of the new medical device regulations became active on January 1st, 2013. However, details of the new regulations aren’t fully available yet.
The Emergo Group, a medical device consultancy, provided an early analysis of the new regulations. According to information posted on a company blog, the new regulations impact conformity assessment, quality and safety issues and medical device vigilance processes. As of now, new regulations on importation, adverse event handling and medical device classification have been approved.
Overall, the new regulations may indicate a more challenging atmosphere for medical device companies. Instead of playing a direct regulatory role, the Roszdravnadzor will defer decisions to expert reviewers. In addition, the new regulations indicate there may not be established timelines for medical and clinical testing; this could lead to multiyear approval delays for medical devices. In addition, changes have been made in medical device registration fees.
Emergo Group (http://emergogroup.com) posted a summary of new regulatory processes. A copy of the text from their Web site is available below:
1. Applicant must obtain an import permit for samples submitted for testing by Roszdravnadzor.
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.
http://roszdravnadzor.ru/main/oficial/22972 (text only available in Russian)
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