What is Fast Track? 
The Thai Food and Drug Administration (Thai FDA) has introduced a "Fast Track" pathway to mitigate supply chain disruptions in raw materials and packaging affecting essential medical device imports. Under this pathway, the review timeline for change notifications of an approved medical device has been reduced from normally 15 workdays to 5 working days.

Thai FDA will thoroughly review only the necessary documents related to safety and performance of medical devices during the crisis.

 

Priority Medical Devices — Watch List
Thai FDA gives priority to medical devices that are on the Watch List — products identified as essential and in high demand, including:

• Hemodialysis (HD) solutions
• Endotracheal tubes
• IV drip sets
• Suction sets and suction tubes
• Urine bags and urinary catheters
• Plastic gowns
• Sterile wound dressing set

 

Change Notifications that are Not Eligible

The following change notification topics are excluded from the Fast Track pathway:

• Changes to Indications of medical device
• Changes to physical manufacturer or manufacturing site(s)

Our regulatory specialists are committed in assisting international manufacturers registering and importing medical devices in Thailand.

Qualtech Consulting Corporation has been a trusted partner for medical device manufacturers for over 26+ years. Whether you're a local startup or an international player, we empower your devices to enhance lives.

Connect with us today to unlock your medical device potential.

 

Reference

Thai FDA_Fast Track: Urgent Measures for Medical Devices in Response to the Middle East Crisis