Russian President Vladimir Putin signed 09.03.2015 an amendments ( link in Russian ) to the article #80 of the Russian Federal Law #323 “On the Fundamentals of Health Protection in the Russian Federation”. These amendments implements additional regulation for implantable medical devices included in the recently approved list for national reimbursement programmes.
What is now regulated?
- Manufacturer`s maximum sale prices for implantable medical devices.
- Maximum wholesale markup for implantable medical devices.
- Maximum retail markup for implantable medical devices.
How it will be regulated?
- Methodology for detecting prices and markups will be published by the Government.
- State registration procedure for prices and markups will be implemented by Roszdravnadzor (Russian medical device regulator).
- Public state registry of prices and markups will be implemented Roszdravnadzor.