As Thailand enters a new wave of the Covid-19 pandemic, Medical Device Control Division adds 11 more items to the list of Covid-19 related products with access to a special fast track approval through a new electronic platform.

Previously, the fast-track route includes only 10 items:

1. Surgical Mask,

2. N95 Mask

3. Surgical gown

4. Isolation gown

5. Hair Cover

6. Goggles

7. Face Shield

8. Hood Covering

9. Leg Covering

10. Nasopharyngeal swab, Nasal swab, and COVID-19-related specimen collection kit

With the new regulation, the following items were added:

1. Examination gloves

2. Non-electrical thermometer

3. Electrical thermometer

4. Powered air-purifying respirator: PAPR

5. Negative pressure isolation chamber

6. Syringe

7. Needle or Syringe with needle or needle

8. Pulse oximeter

9. Ventilator

10. High flow nasal canular oxygen: HFNC

11. UVC

Applications for these items can be submitted by first accessing the E-submission Fast Track then informing the authority by filling in a Google form: https://forms.gle/NDdcrkkuAhZRQPZq6. This decree will take effect on the date of its publication in the Government Gazette.

 

 

References:

E-submission Fast Track Guidance

List of COVID-19 Products Applicable for Fast Track Route Approval

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