On 30 April 2021, substantial amendments were made to the licensing procedures for activities associated with the manufacture of medical equipment. The Law No. 128-FZ was adopted, which amends the Federal Law on the Fundamentals of Health Protection of Citizens and makes changes to several paragraphs of the Federal Law on Licensing.
It is important to note that the licensing of the production of medical devices has been cancelled, while the licensing of maintenance remains in place. Consequently, the licensing of production has been replaced by a system of inspections.