Thai Food & Drug Administration

Thai Food and Drug Administration (FDA)  

Food, medicines, and devices that are being used for health purposes or for general or specific consumption must undergo registration under the Ministry of Public Health. According to the FDA Thailand, the health products are categorized into six such as: drug, food, narcotics, hazardous substances, cosmetic and medical devices.

It must undergo the standard of validation and registration so that consumers can validly advertise and distribute it to the consumer assuring its standard and scientific study are done for its safe distribution to the market.

Process of registration of Medical Devices in Thailand.

1.     Classification and Reclassification
-       In this stage, the applicant must gather the documents which are required by the Food and Drug Authority, which must be submitted to the Ministry of Health through an online application (e-process) which shall undergo classification stage. In case, the device is classified as not under the FDA classification, it will be rejected. In case, the food, medicine, or devices are classified as under FDA, it will be undergoing reclassification in accordance with its purpose.

2.     Storage Licensing

-       After its approval on classification and reclassification stage, the documents for its storage must be prepared and certified by the producer and follow the standard and guidelines in accordance with the warehouse where it will be stored. It can be approved or disapproved. In case, it is approved, a Storage License shall be issued.

3.      Importation Licensing

-       The importation license (if necessary) shall proceed so that the food, drug, narcotics, hazardous substances, cosmetics and devices can enter the Customs. This is only for the products which origin is

4.     Advertising of FDA approved products
-       The products which are approved as FDA products shall be undergoing an advertising license before it will be advertised in the market. Its information must be matched together with the approved scientific evidence presented during the classification and re-classification stage.

5.     Distribution of FDA approved products

-       The FDA approved products which have storage, importation, advertisement license shall be needing the Distribution license to be able to sell inside the Kingdom.

Juslaws & Consult

Juslaws & Consult has a specialized team that deals with the registration of your products either locally produced or imported which are intended for medical use to be registered at the Ministry of Health.