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.
Pingback: Russia Enforced Price Regulation for Implantable Medical Devices | Medical Device Regulations in Russia and Eurasian Union
Pingback: Thirty days to provide information on prices for implantable medical devices | Medical Device Regulations in Russia and Eurasian Union
Pingback: Five Things to Know about Medical Device Regulations in Russia in 2016 | Medical Device Regulations in Russia and Eurasian Union
Pingback: Three Things You Should Know About Medical Device Regulations in Russia, July 2017 | Medical Device Regulations in Russia and Eurasian Union
Pingback: Extension of the List of Implants for National Healthcare Programs | Medical Device Regulations in Russia and Eurasian Union