1. Medtech Insight
  2. >>Geography
  3. >>International

Global Medtech Guidance Tracker: January 2022

 
• By Vibha Sharma

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.

The updated tracker includes new guidance from the European Commission’s Medical Device Coordination Group explaining how sponsors should collect and...

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?

More from International

‘Small Business’ Applications For Waiver Of Device User Fees To Be Streamlined By US FDA

 
• By Brian Bossetta

FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.

Global Medtech Guidance Tracker: May 2025

 
• By Vibha Sharma

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

Get Ready For International Harmonization Before Approaching QMSR Deadline, Says Regulatory Expert

 
• By Brian Bossetta

During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.

Health Literacy Issues Cost Major Economies $303B Per Year, Recent Study Shows

 
• By David Ridley

By addressing disparities in health literacy, particularly in the areas of oral care, bone health, nutrition and air pollution, the consumer health industry can “save lives and billions in healthcare costs, boosting productivity and increasing GDP,” says a new report from Haleon and Economist Impact.

More from Geography

FDA Outlines Responsibilities For Owners Of Transferred 510(k)s

 
• By Elizabeth Orr

The US FDA's new draft guidance details the responsibilities of new owners of 510(k) clearances, including making timely updates device listings in FURLS and GUDID to maintain accurate information for safety alerts and recalls. Comments on the draft are accepted until 4 August.

US House Budget Sets FDA FY26 Funding At $3.2B

 
• By Sue Sutter and Derrick Gingery

A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.

Panel: FDA’s Home Healthcare Initiative Holds Promise, But Challenges Remain

 
• By Elizabeth Orr

During a recent FDLI panel, experts discussed the FDA's Home Healthcare initiative, highlighting its potential benefits and challenges. Key issues include usability testing, reimbursement, labeling for home use, and the need for innovation while ensuring patient safety.