With Special Announcement No. 136 the Thai FDA increased the regulatory status of Hyaluronic Acid-based dermal fillers from Notified to Licensed. This change will effectively increase the cost and time required to obtain an Import License for these devices under the current regulations.
This change was announced on September 13, 2019 and goes into effect 180 days later (on March 11, 2020). Products covered by an existing Import License will retain market access until expiry. All new or renewal applications are subject to the new requirements.
The requirements apply to devices intended for sterilization of human or animal skin or medical formulated from ethyl alcohol or ethanol (minimum of 70% by volume). Government processing fees will depend on device classification as per the table below. Processing times are targeted at 6 months.
GOVERNMENT PROCESSING FEES
|Class 1||THB 25,000 (US$740)|
|Class 2||THB 38,000 (US$1,120)|
|Class 3||THB 63,000 (US$1850)|
|Class 4||THB 88,000 (US$2,590)|
CLASS I “LICENSED” MEDICAL DEVICES – 8-12 MONTHS PROCESSING TIME
- Gloves (surgical & exam)
- HIV test kits
- Contact lens (corrective & cosmetic)
- HA dermal filler (added 3/11/20)
CLASS II “NOTIFIED” MEDICAL DEVICES – 6-8 MONTHS PROCESSING TIME
- Physical therapy equipment
- Alcohol detectors
- Breast implants
- HIV test kits (research)
- Alcohol-based sterilants (added 9/13/19)
CLASS III “GENERAL” MEDICAL DEVICES – 2-6 WEEKS PROCESSING TIME
- All other medical devices
Contact Asia Actual for more information regarding regulatory changes in Thailand