Global Medtech Guidance Tracker: January 2022

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-eight documents have been posted on the tracker since its last update.

Guidance word in red keyboard buttons

Thirty-eight guidance documents on medical devices and diagnostics issued by regulatory authorities from around the world were added to Medtech Insight’s Guidance Tracker in the past month.

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 International

Diagnostics Are Essential, But How Can Companies Ensure A Fair Price?

 

Biotech and pharma are increasingly clear about one thing: They need diagnostics. But with prices suppressed, how have diagnostics companies proven their utility without going under?

Medtech Looks For Relief As Trump Hits Pause On Most Tariffs

 
• By 

The medtech industry hopes to use a 90-day pause on tariffs to negotiate a “zero for zero” exemption. However, recent public comments from President Donald Trump suggest the health care sector may still be at risk.

IMDRF Offers Granular Playbook On ‘Regulatory Reliance’ Program Development And Implementation

 
• By 

International device regulatory group IMDRF has issued a new playbook on “regulatory reliance,” which allows regulators to make use of assessments performed by trusted regulatory partners. The document is the first to offer a detailed guide on developing and implementing these agreements.

Medtech Industry Faces Tariffs Despite Pleas for Exemption

 
• By 

Medical devices, diagnostics, and equipment face tariffs announced by President Donald Trump, despite industry pleas for exemption. The tariffs, ranging from 10%-49%, impact most countries trading with the US, potentially hindering innovation and increasing costs in the medtech sector.

More from Geography

EU Harmonized Standards Continue To Trickle In Under MDR

 

Well over 200 European standards need harmonizing under the MDR. But only around 12% have been attended to so far.

Medtech Looks For Relief As Trump Hits Pause On Most Tariffs

 
• By 

The medtech industry hopes to use a 90-day pause on tariffs to negotiate a “zero for zero” exemption. However, recent public comments from President Donald Trump suggest the health care sector may still be at risk.

Medtechs Eye German Health Minister Switch As Governing Parties Reach Coalition Agreement

 
• By 

The architect of Germany’s hospital reform, Karl Lauterbach, will not be retained as health minister according to how the new CDU/CSU-SPD coalition government plans to spread the ministerial portfolios.