Singapore Regulators To Streamline Framework For Software And Apps

A consultation by Singaporean regulators on telehealth devices is seeking to speed access to new and innovative medical device software and apps.

Singapore’s Health Sciences Authority (HSA) has proposed a set of guidelines on telehealth devices that include clarification on which products would qualify as medical devices and which of the agency’s evaluation pathways – immediate, expedited, abridged or full – they should follow.

Innovation in telehealth technology has advanced at a rapid pace and the HSA wants to refine and streamline its regulatory...

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 Approvals

More from Policy & Regulation

MHRA’s Tallon Hails PMS Regulation As Start Of UK Device Framework Transformation

 
• By 

16 June marked the first major new regulatory instrument in the UK’s post-Brexit transition to a standalone device regulatory system for Great Britain.

Increasing Safety Concerns Spur Scrutiny of Device Plastics Use

 
• By 

With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.

With LDT Rule DOA, Could FDA Shift Focus To RUOs?

 

Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?