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Registration Certificate for a Medical Device


A registration certificate for a medical device is an entry in the state register of medical devices and organizations (individual entrepreneurs) engaged in the production and manufacturing of medical devices, confirming the fact of state registration of a medical device in accordance with the procedure established by the Government of the Russian Federation1.

  1. Federal Law No. 323-FZ of November 21, 2011 "On the Basics of Health Protection of Citizens in the Russian Federation", as amended on March 1, 2026, Article 2, paragraph 24 // Official Compilation of Legal Acts of the Russian Federation. 2011. No. 48. Item 6724. ↩

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