IMDRF Issues Proposed Guidances On Device Auditors, Global UDI System

The International Medical Device Regulators Forum issued proposed guidance documents on monitoring of device auditing organizations, training for auditors and core elements of a global UDI system.

The International Medical Device Regulators Forum released three draft guidance documents addressing the recognition and monitoring of device auditing organizations, minimum competency and training requirements for auditors, and the core elements of a globally harmonized unique device identification system.

The documents were posted on the group’s website

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 Asia

FDA Blocks Some Olympus Endoscopes From Entering US

 

After multiple warning letters and safety communications, the US FDA has decided to block the import of certain endoscopes from Olympus. In total, the agency’s action pertains to 58 device models manufactured by the Japanese firm used in urinary, respiratory, abdominal and pelvic procedures.

New EU Rules Limit Chinese Participation In Medtech Procurement

 

From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.

Industry Execs Talk Tariff Turbulence During MD&M East

 

During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.

India-UK Free Trade Agreement Sets Stage For Medtech Growth, But Industry Demands Safeguards

 
• By 

Announced after three years of negotiation, the FTA eliminates tariffs on 99% of Indian product types, covering nearly all trade value, and reduces tariffs on 90% of UK products. Although not yet formally signed, the deal is being positioned by the Indian government as “transformative,” with an estimated economic impact of $6.4bn for the UK alone by 2040.

More from Geography

Former Top OIG Attorney Gives Inside Look At Fraud Prevention

 
• By 

Former HHS-OIG attorney Rob DeConti emphasized the significance of data analytics and compliance in combating healthcare fraud, urging medical tech companies to adopt robust measures to prevent potential risks.

Deaths And Serious Injuries Linked To A Pair Of Heart Device Recalls

 

Two recent recalls from the US FDA involve three deaths linked to an issue with an Abiomed heart pump — as well as three serious injuries related to angiographic catheters from Cook Medical.

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.