Eurasian Medtech System Battles To Be In Place This Year

The Eurasian Economic Union's system for regulating medtech products is dropping into place, but too slowly as some see it, and still with many questions remaining over the content. However, it remains a fixture for the future, and device companies serving the region need to be prepared.

The Eurasian Economic Union’s common market for medical technology products retains a headline target of starting to take device submissions before the end of the year. To many, including Alexey Stepanov, regulatory manager for Russia and the CIS with Abbott Molecular Inc., this is an unlikely eventuality.

Addressing the "emerging markets regulatory affairs" stream of Informa Life Sciences Medtech Summit 2016 in Brussels (June 13-16), Stepanov provided...

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

More from Europe

EU Life Sciences Strategy Must Address ‘Regulatory Lasagna’

 

MedTech Europe is ready to become involved and shape Europe’s Life Sciences Strategy and help drive regulatory simplification from the top to make the EU “the world’s most attractive place for life sciences by 2030.”

Questions Over UK Prevention Agenda Within NHS 10-Year Plan

 
• By 

The UK government’s blueprint to deliver an NHS "fit for the future" was released on July 3.

June 2025: A Bumper Month For New EU Medtech Documents And Initiatives

 

The rate at which new documents to support the implementation of EU medtech regulations are issued has slowed of late; but June bucked the trend, with a flurry of activity.

NICE’s Rules-Based Pathway And Innovator Passports Get Go-Ahead In UK NHS 10-Year Plan

 
• By 

The NHS 10-Year Plan officially released on July 3 will crystalize NICE’s Rules-Based Pathway – a new concept for medtech evaluation that will come with a guarantee of funding – but only for a select number of products. Government to also introduce “innovator passport” to speed innovation into NHS.

More from Geography

June 2025: A Bumper Month For New EU Medtech Documents And Initiatives

 

The rate at which new documents to support the implementation of EU medtech regulations are issued has slowed of late; but June bucked the trend, with a flurry of activity.

NICE’s Rules-Based Pathway And Innovator Passports Get Go-Ahead In UK NHS 10-Year Plan

 
• By 

The NHS 10-Year Plan officially released on July 3 will crystalize NICE’s Rules-Based Pathway – a new concept for medtech evaluation that will come with a guarantee of funding – but only for a select number of products. Government to also introduce “innovator passport” to speed innovation into NHS.

New Draft Guidance Clarifies FDA’s UDI Rules For Combination Products

 
• By 

The FDA has released draft guidance clarifying UDI rules for drug- and device-led combination products. The document specifies labeling requirements and makes recommendations to reduce confusion between UDIs and NDCs. Comments are being accepted until Sept. 24.