THAILAND ELEVATES REGULATORY STATUS OF DERMAL FILLERS

With Special Announcement No. 136 the Thai FDA increased the regulatory status of Hyaluronic Acid-based dermal fillers from Notified to Licensed (Class 4). 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.

GOVERNMENT PROCESSING FEES
Class 1THB 25,000 (US$740)
Class 2THB 38,000 (US$1,120)
Class 3THB 63,000 (US$1850)
Class 4THB 88,000 (US$2,590)


CLASS I “LICENSED” MEDICAL DEVICES

1 YEAR PROCESSING TIME

  • Condoms
  • Gloves, surgical and exam
  • Syringes
  • HIV test kits
  • Contact lens (corrective and cosmetic)
  • Injective Hyaluronic for defective skin (09/13/2019)

CLASS II “NOTIFIED” MEDICAL DEVICES 

6-8 MONTHS PROCESSING TIME

  • Physical therapy equipment
  • Alcohol detectors
  • Methamphetamine Detectors
  • Breast implants
  • Opthalmic Viscoelastic Device
  • Concentrate for haemodialysis (10/03/2017)
  • Alcohol based sterilizer (09/13/2019)
  • Alcohol gel sanitizer (09/13/2019)
  • Teeth whitening devices (Hydrogen peroxide 6% +, fluorite 0.11% +) (09/25/2018)
  • Intense Pulsed Light (IPL) devices (pending)
  • Automatic External Defibrillators (AED) (pending)
  • Syphilis Screening Tests (pending)

CLASS III “GENERAL” MEDICAL DEVICE

2 TO 6 DAYS PROCESSING TIME (TYPICAL)

  • All other medical devices
  • Including dental equipment

Contact Asia Actual for more information regarding regulatory changes in Thailand