What is “Unregistered Medical Device” in Russia?

As is known, at the beginning of 2015, Russia adopted the Federal Law # 532 (link in Russian) and implemented amendments to the Russian civil and penal codes enacted stiffer criminal penalties of up to 2,000,000 rubles (app. $30,000) and a jail term of up to 12 years (for aggravating circumstances) for the manufacturing, sale or trade of counterfeit and unregistered pharmaceuticals and medical devices. In August 2015 Russian medical device expert organization VNIIMT held a seminar about control of circulation of medical devices and clarified, what medical devices are considered as “unregistered” and may come under jurisdiction of this law.

Here is the slide:

4 thoughts on “What is “Unregistered Medical Device” in Russia?

  1. Pingback: Five Things You Should Know about Medical Device Regulation in Russia, CIS and the Eurasian Union in 2015 | Medical Device Regulations in Russia and Eurasian Union

  2. Pingback: Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Economic Union, June 2016 | Medical Device Regulations in Russia and Eurasian Union

  3. Pingback: Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union, September 2016 | Medical Device Regulations in Russia and Eurasian Union

  4. Pingback: Three Things You Should Know about Medical Device Regulatory Changes in Russia in 2017 | Medical Device Regulations in Russia and Eurasian Union

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s