Thai FDA has set a higher regulatory status for alcohol-based hygienic products to ‘Medical Devices requiring Notification (Class 2)’. In line with this change, the Medical Device Committee has updated its definitions and requirements as follows:
1. Alcohol-based hand sanitizer" are products consisting of ethyl alcohol/ethanol, or isopropyl alcohol/ isopropanol and may contain other compounds such as flavouring agents, preservatives which are in various forms such as lotion, solution, cream, gel, foam, spray: including non-pressurized sprays, continuous (bag-on-valve) sprays, and aerosol (no chlorofluorocarbon (CFC) based spray)with the purpose of cleaning hands without using water.
2. All alcohol-based hand sanitizers must have undergone notification process prior to importation.
3. All alcohol-based hand sanitizers must adhere to the following standards:
(a) Must contain at least 70 % (v/v) of ethyl alcohol/ethanol or isopropyl alcohol/ isopropanol.
(b) Must comply with EN 1500:2013 (or newer standard): Chemical disinfectants and antiseptics Hygienic hand rub; or with standards recognized by the Food and Drug Administration as published in the Government Gazette or their equivalents.
(c) Stability test results follow ASEAN guideline on Stability Study of Drug Product.
4. Manufacturers and importers of alcohol-based hand sanitizers must provide labels in Thai or English, printed legibly, and prominently placed on the outer packaging or primary containers. Labels should contain the following information:
(1) Trade name of the product
(2) List of all substances as prescribed by the Food and Drug Administration. Substances should be listed in descending order by quantity.
(3) Name and address of the manufacturing site. Importers should provide the address of the manufacturer.
(4) Year and Month; or Month and Year of manufacturing date. Manufacturing year must be 4 digits.
(5) Year and Month; or Month and Year for expiration date or use before date. Expiry date must be 4 digits
(6) Number or letter indicating LOT number or manufacture number.
(7) Registration license number of the medical device to be notified.
(8) Instruction for use and storage methods
(9) Warnings and precautions.
(10) Auxiliary label: “For cleaning hands without water
(11) Auxiliary label: "Do not place or use near flames
(12 Auxiliary label: "For external use only"
Labelling (10) (11) and (12) must in in Thai
5. Importers should attach labels on the product package before selling. This should be done within thirty days from the date of medical device's checking and release.
6. Drug or Cosmetic Certificate holders having alcohol-based sanitizers within their product scope should apply for establishment import license and prepare the documents required for medical device notification. These shall be done within 30 days from the effective date of this announcement.
7. This announcement shall come into force after 180 days following the date of its publication in Government Gazette.
Translated from official ThaiFDA announcement, by: