Food, food supplements, medicines, and devices that are being used for health purposes or for general and specific consumption must undergo registration under the Ministry of Public Health, fulfill registration requirements, and obtain FDA approval prior to distribution. This is for the sake of the consumers' safety and health.
According to the FDA Thailand, the health products are placed into six separate categories, namely: drugs (or psychotropic substances), food and food additives, narcotics, hazardous substances (or volatile substances), and cosmetic or medical devices. Any of these products must undergo the standard of validation and registration, so that sellers can validly advertise and distribute it to their consumers assuring its standard. Scientific study is done for its safe distribution to the market.
1. Classification and Reclassification
In this stage, the applicant must gather the documents which are required by the Food and Drug Authority. These must be submitted to the Ministry of Health through an online application (e-filing) and shall undergo the classification stage. If the device is classified as not under the FDA classification, it will be rejected. If 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 during the classification and reclassification stage, the documents for its storage must be prepared and certified by the producer. They must follow the standard and guidelines in accordance with the warehouse where it will be stored. It can be approved or disapproved. If it is approved, a Storage License shall be issued.
3. Import Licensing
Import licenses might be necessary to obtain, so that the food, drugs, narcotics, hazardous substances, cosmetics and devices can enter through Customs. This is usually only for the products that are imported from overseas, and therefore originate from another country outside of Thai market. These items are typically produced by foreign companies.
4. Advertising of products with FDA approval
The products that have the FDA's approval will need an advertising license before they can 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 that have storage, importation, advertisement licenses will also need a Distribution license to be able to sell inside the Kingdom.
It is important to note that companies who wish to produce their own products in a factory would also require a separate manufacturing license.
Thai law prohibits the import and distribution of products that do not meet Thai FDA standards and undergone the process of gaining storage, importation, advertising and distribution licensing.
Thailand requires registration and licensing of any products that the Thai FDA categorizes: drugs (or psychotropic substances), food, narcotics, hazardous substances (or volatile substances), and cosmetic or medical devices.
Juslaws & Consult stand out above other agencies. We have a specialized team that deals with obtaining the FDA permit, registration certificate, and licensing of your products, either locally produced or imported, that are intended for medical use, require licensing, and need to be registered at the Ministry of Health.
