Health Canada to adopt STED format for Class III and IV devices

Health Canada is planning to adopt the STED, the global submission document, for submissions relating to Class III (medium- to high-risk) and IV (highest-risk) medical device premarket licence applications1.

Health Canada is planning to adopt the STED, the global submission document, for submissions relating to Class III (medium- to high-risk) and IV (highest-risk) medical device premarket licence applications1.

The STED – or the Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip 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 Archive

Final Chance To Have Your Say: Take Scrip's Reader Survey This Week

 

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access Scrip, or if you love it how it is, now is the time to have your voice heard.

Galapagos Expands Point-Of-Care CAR-T Study To The US

 

CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.

Analysts Split On Eisai’s Chances Of Changing EU Regulator’s Mind On Leqembi

 

A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand

More from Scrip

Beyond AI Hype: Tokyo-1’s Real Answer On How To Innovate Pharma R&D

 
• By 

Bringing supercomputing power to bear on large-scale calculations for pharma R&D, Tokyo-based Xeureka explains the practical use of AI to empower innovation beyond the hype.

Regeneron Wins Long-Sought FDA Nod For Lynozyfic In Myeloma

 

The agency gave accelerated approval to the BCMAxCD3-directed bispecific antibody, which had been the subject of an August 2024 CRL.

Bluebird Builds Out Leadership Team Under Private Equity Ownership

 

The gene therapy developer appointed a new president, chief medical officer and chief of staff following the closing of its acquisition by private equity firms Carlysle and SK Capital.