Russia will use risk-oriented approach for medical devices circulation control

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government russia

The Chairman of the Government of the Russian Federation Dmitry Medvedev signed a document, which establishes that Roszdravnadzor would use a risk-oriented approach for the state control of legal entities and individual entrepreneurs in the area of circulation of medical devices. This will allow to improve the effectiveness of control and surveillance activities in this area while ensuring the optimal use of material, financial and human resources of federal state control authorities.

In particular, the introduced changes define the criteria and procedure for assigning a specific risk category to the objects of state control and frequency of scheduled inspections with regard to the objects of state control depending on their risk category.

The document also established that Roszdravnadzor should maintain a list of objects of state control that were assigned a specific risk category and post, on its official website, the information on objects assigned a significant risk.