Med Comply Global

Russia

Russia

 

The population of Russia is approximately 146 million people. Russia is a major global power with a large and diverse economy that spans natural resources, manufacturing, and technology. The official language is Russian.

The Russian healthcare system consumes approximately 5-7% of the national budget. The pharmaceutical market is one of the largest in Europe, valued at over $20 billion, with a high percentage of imports. The medical devices market is estimated at $4 billion.

Medicines and medical devices must be registered with the Ministry of Health before being marketed.

Competent authorities:

  • Ministry of Health of the Russian Federation: Oversees health policies, regulations, and the healthcare system.
    Website: https://www.rosminzdrav.ru/
  • Federal Service for Surveillance in Healthcare (Roszdravnadzor): Regulates pharmaceutical and medical device registration.
    Website: http://www.roszdravnadzor.ru/

Main legislative acts:

  1. Federal Law No. 61-FZ, dated April 12, 2010, “On Circulation of Medicines.”
  2. Government Decree No. 825, dated October 1, 2017, “On Registration of Medicines.”