Deadline Reprieve Mooted For Russian Registration Replacements

23 Sep 2016

Medtech companies are being warned that if they do not renew their registration certificates in Russia by the start of 2017, their certificates will become invalid.

Time is running short for companies that still need to replace their pre-2013 Russian medical technology registration certificates with new versions, as provided for in the recent regulatory overhaul introduced with Resolution 1416.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

Start your 7-day free trial
Explore trusted news, analysis, and insights
Access comprehensive global coverage
Enjoy instant access – no credit card required

Start Free Trial

Already a subscriber?

Notified Bodies Warn Of Hurdles In The Way Of Their AI Designations

17 Apr 2025

• By Amanda Maxwell

Will challenges in the way of designations of notified bodies that assess AI-enabled medical devices create delays and bottlenecks and slow EU medtech innovation?

Keeping Germany’s Medtech Industry Apprised, Advised and Incentivized in Turbulent Times

16 Apr 2025

• By Ashley Yeo

A change of government, hospital reform and a drive towards healthcare digitization are keeping German medtech manufacturers on their toes. Making the MDR more user-friendly and winning support for a medtech strategy are arguably bigger priorities. US export tariffs have also pushed their way onto the agenda. BVMed chief executive Marc-Pierre Möll puts it all into context.

Edwards Mitral Valve Replacement System SAPIEN M3 Receives CE Mark

15 Apr 2025

• By Natasha Barrow

“We believe [the SAPIEN M3] launch alongside PASCAL and EVOQUE will help support the company’s target of $2bn in transcatheter mitral and tricuspid therapies sales by 2030,” noted analysts from Leerink Partners.

Unlocking Potential: Could EU’s New Surgical Centers Drive Demand For Advanced Medtech?