Thailand FDA Applications

by Admin on July 19, 2013

The number of  Thailand FDA applications are rising, largely due to the booming medical tourism trade. There are an increasing amount of tourists and expats with money to spend which has led to more and more medical service suppliers are venturing into the Thailand market.

However importing pharmaceuticals, or other medical, narcotic and toxic substances into Thailand requires registration with the FDA.

The Thailand FDA has a clear process which must be complied with depending on the type of product that is being imported. In general though, importers need to provide fairly comprehensive details about the company that will import the product, plans and photos of the production facility and evidence to show that Thai law requirements have been met in respect of manufacturing, including, for example, lighting and ventilation, proper areas for preparation, the type of equipment that will be used.

FDA fees vary greatly depending on the item being registered.

The time required for filing product registration application and receiving registration certificates with the FDA can vary widely.

The Thai FDA also has authority to control product advertising, ensuring that the claims made by producers are backed by proper evidence and studies.

FAD applications can be complicated and timely and are a hugely administrative process, conducted solely in Thai. Consulting a law firm that is familiar with the Thai FDA registration and its processes can help to make sure that applications are expedited and dealt with as smoothly as possible.

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The Work of the Thailand Food and Drug Administration

{ 2 comments… read them below or add one }

John Lleo October 21, 2013 at 18:41

The Thai FDA are nothing but an inept bureaucracy that know nothing about science. After selling our product in their market for over 10 years they decide to restrict it’s use without any scientific verification that it is harmful in any way. Even involved the FAS Embassy staff to assist, supplied them with a complete product dossier and even had legal representation to substantiate our product. It seems no one within the Thai FDA knows how to read. No wonder they are a third world country.

admin October 28, 2013 at 02:32

In our experience the obstacles with FDA registration are the complaints of the regulations. One large issue with the FDA is that they over analyze and over request information from applicants. We welcome your comments on your experience. however our experience with the FDA has been more positive.

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