Hand sanitizer regulations
BINH THAI

BINH THAI

General Manager, Asia Actual Thailand

Questions?

THAILAND SUSPENDS PLAN TO REGULATE HAND SANITIZER AS MEDICAL DEVICE

In the wake of the COVID-19 outbreak, the Thai FDA announced on March 5, 2020 that they will cancel their plans to begin regulating alcohol gel sanitizers as medical devices. As initially reported in a blog post in March of 2019, the Thai FDA had planned to transition oversight of sanitizer gel with more than 62.4% alcohol from the Bureau of Cosmetic and Hazardous Substances to the Medical Device Department. Their intention was to prevent insufficiently strong sanitizers from being used as disinfectants in places like schools or hospitals but due to the outbreak and longer review times for medical devices, they have decided to indefinitely postpone this transition.

Furthermore, the FDA is actively urging manufacturers and importers to supply consumers with gel sanitizers of over 70% alcohol to help contain the spread of the novel corona-virus.

Background on Thai FDA

Thailand medical device registration is managed by the Medical Device Control Division of the Thai Food and Drug Administration (FDA) according to the Medical Device Act B.E. 2551 (2008). While changes are scheduled for later in 2018 that will bring alignment with the ASEAN Medical Device Directive (AMDD), the current regulatory system requires medical devices to apply for and obtain a License, Notification, or Certification from the FDA prior to importation depending on classification.

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 (September 13, 2019)
  • Breast implants (May 20, 2020)
CLASS II “NOTIFIED” MEDICAL DEVICES 6-8 MONTHS PROCESSING TIME
  • Physical therapy equipment
  • Alcohol detectors
  • Methamphetamine Detectors
  • Ophthalmic Viscoelastic Device
  • Concentrate for haemodialysis (October 3, 2017)
  • Alcohol based sterilizer (September 13, 2019)
  • Alcohol gel sanitizer (September 13, 2019) suspended indefinitely
  • Teeth whitening devices (Hydrogen peroxide 6% +, fluorite 0.11% +) (September 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

We can help

Asia Actual is available to answer questions regarding the new requirements. Contact us to arrange an initial conversation.