In a significant move to enhance healthcare delivery, the Thai FDA has introduced a priority track to expedite the approval of 6 key medical devices targeting major Non-Communicable Diseases (NCDs). This initiative is designed to expedite the regulatory process for devices that address critical healthcare challenges. By prioritizing approval for these devices, the Thai FDA aims to ensure quicker access to life-saving solutions.
Priority Track Overview
This track accelerates the registration of devices specifically designed to prevent, diagnose, or treat diabetes, hypertension, hyperlipidemia, cardiovascular diseases, and cancer.
The devices eligible for this expedited review process include:
- Glucose Meter
- Blood Pressure Monitor
- Blood Lipid Test Device
- Echocardiogram
- Cancer Screening Tools
- Electrocardiograph (ECG or EKG)
Registration Requirement and Timeline
The registration pathways remain unchanged: Full Evaluation Pathway, Abridged Pathway, and HSA Reliance Program. The priority track allows faster queueing of applications, resulting in quicker market access. There’s no fixed timeline for this scheme yet.
Conclusion
This priority track offers an opportunity for companies whose devices fall under this priority category to expedite their products' market entry. Contact us today to take advantage of this streamlined approval process and get your device to the Thai market faster.
Qualtech Consulting Corporation has been a trusted partner for medical device manufacturers for over 25 years. Whether you’re a local startup or an international player, we empower your devices to enhance lives.
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References:
Thai FDA Press Release: 2025 Update
Thai FDA Press Release: Medical Device Control Division Introduced Priority Track To Support National Policy