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

Thailand Issues New Medtech Regulations – Industry Guidelines To Follow

 
• By Ashley Yeo

More parts of the Thai FDA’s new medtech regulations will come into force in mid-March, following the first tranche last month. Other changes will become effective later in 2021 and certain elements of the system remain a work in progress.

NaughtyNut

New medtech regulations aligned with the ASEAN Medical Device Directive (AMDD) were published by the Thai FDA in the Government Gazette on 15 February. The first of the 11 new or updated regulations came into effect immediately, while others will enter into force in 17 March.

The changes and information on the new risk class 1-4 (low to high risk) system of medical device and IVD regulation were outlined by

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 Asia

More from Geography

Don’t Sleep On Inspections: Experts Warn FDA Maintains Enforcement Resources

 
• By Brian Bossetta

Manufacturers of medical products would be foolish to think that recent upheavals at the US FDA will result in a lack of inspections in the coming years. A panel of experts discussed the current state of inspections during a webinar hosted by the Food and Drug Law Institute.

Global Medtech Guidance Tracker: April 2025

 
• By Vibha Sharma

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. 25 documents have been posted on the tracker since its last update.

South Korea Adds Digital Health Rules To Already Complicated Regulatory Landscape

 
• By Elizabeth Orr

A New South Korean law, the Digital Medical Products Act, enhances regulation for digital health products. Medical devices in the country are categorized both by risk and by similarity to already authorized devices. The approval process may stretch to 515 days for new manufacturers.