Global Medtech Guidance Tracker: September 2018

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-three new guidance documents were posted on the tracker since its last update.

Guidance word in red keyboard buttons

[Editor's note: Check out the complete Global Medtech Guidance Tracker, with sortable and searchable listings going back to 2014.]

Thirty-three new guidance documents on medical devices and in vitro diagnostics issued by regulatory authorities from around the world were...

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

Additional Death And Injuries Added To 2024 Philips Ventilator Recall

 

Philips Respironics has updated instructions for use for three ventilators that were included in a May 2024 recall. The company also added three potential injuries and one death to the original number.

Global Medtech Guidance Tracker: July 2025

 

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

Inspection Readiness 101: Be Prepared To Avoid Common Pitfalls When The FDA Comes Knocking

 

A panel of regulatory pros offered stakeholders tips for avoiding FDA citations after facility inspections. The July 29 webinar, hosted by ProPharma and Hyman Phelps and McNamara, follows the agency’s May announcement that it plans to up random foreign inspections.

Award-Winning Lioness Implant Addresses ‘Silent Emergency’ Of Preterm Birth

 
• By 

The Lioness non-surgical silicon ring implant is designed to put an end to pre-term births, sparing maternal anguish and saving health system costs. PregnanTech won the Biomed Israel 2025 medtech start-up award, and Limor Sandach told In Vivo how a non-digital technology beat off stiff competition.

More from Geography

Swiss Medtech To Battle ‘Arbitrary’ 39% US Tariff

 
• By 

In return for building a successful US export business, Switzerland has been handed a 39% tariff effective immediately by the Trump administration. Diplomatic channels have been reopened to undo the tariff. Meanwhile, the medtech industry is looking to develop OUS markets for Swiss exporters.

Injuries And Deaths Linked To Boston Scientific Cardiac Devices. Company Responds

 

The US FDA issued a pair of early alerts on Wednesday warning customers about serious adverse events associated with two Boston Scientific cardiac devices. Both alerts include numerous reports of injuries and deaths and are part of the FDA’s ongoing pilot to enhance its recall process.

HistoSonics Sells Majority Stake To Investor Syndicate In Deal Valued At $2.25Bn

 
• By 

HistoSonics’ CEO Michael Blue describes the deal as a win-win for all stakeholders and plans to use the money to expand clinical indications, as well as the global reach, for its Edison system.