Update: Innovations for existing medical technology registrations in Russia!
To all manufacturers of medical and medical technical products.
On December 27, 2012 a new law no. 1416 was adopted in respect of amendments to the state registration of medical and medical technical products.
The most important point for manufacturers of medical devices and medical technology products is the Law no. 930, which entered into force on October 17, 2013.
All state registrations/approvals of medical and medical technical products which are unlimited and issued before January 01, 2013, require a description at the latest by December 31, 2016.
The cover of the review will be confirmed by the "Federal Service on Surveillance in Healthcare".
This "Approval" is mandatory. If you will not submit this document, it is not permitted to import or distribute your products inside Russia.
Please also note that in today registrations necessarily real photos are needed by all to be registered products.
Our E3M- Team in cooperation with the Rostravnadzor authority is providing full support.
For questions and information please contact us at any time.
Your E3M Team