On August 25, 2017, CERINS Group successfully completed the medical device registration and certificate issuance support service for Samsung Electronics’ X-Ray product, the GR40CW, with the Federal Service for Surveillance in Healthcare (Roszdravnadzor) of the Russian Federation.

The product is classified as a Class 2b medical device (Products with Increased Risk), and the issued medical device registration certificate remains valid until the discontinuation of the product/model.

Medical devices exported to Russia are required to obtain registration certificates under the supervision of Roszdravnadzor in accordance with Russian Federal Law No. 323-FZ, dated September 21, 2011, “On the Fundamentals of Healthcare Protection in the Russian Federation.” The registration process involves a complex regulatory procedure, including local clinical evaluations, government review, and approval by relevant authorities, which typically takes approximately one year.

Based on its extensive practical experience and expertise in global regulatory affairs, CERINS Group provides comprehensive consulting and registration support services throughout the entire medical device registration process, helping clients successfully navigate complex international certification requirements.