Import Registration in Thai FDA

Registration in Thai FDA

Importing goods in Thailand without Registration in Thai FDA is illegal

In Thailand, for any activity related to food, dietary supplements, medical devices, cosmetics, drugs and traditional medicine (chinese medicine) a registration in Thai FDA is mandatory, even for samples. Let’s see in detail.

Registration in Thai FDA is mandatory

Thai Customs prohibits even the temporary import, promotion or advertisement (online and offline) of any product in the above list without a correct registration in Thai FDA.

Any clinical meeting, product test, even with samples not for sale, is subject to this rule. As exception to this rule, Cosmetics are allowed to be imported for expositions and lab test (not for consumer test!). For this reason, every person importing in Thailand Medical Devices, Dietary Supplements, or drugs not intended for personal use  is  subject to fine and imprisonment (up to 3 years and 200.000THB).

Shipping products by courier with door-to-door term can be a shortcut? Yes, if Custom don’t check the package. If they do it, you will face fine and delays in the best case. In any case this is not the legal solution for a professional and commercial use. We suggest not ot do it.

According to the above, we have seen many attempts to bypass rules that in most cases have been turned in big problems. Shipments blocked for long time in the custom, products seized, and Companies flagged.

Thai FDA registration is easy to get with a professional help. Except for drugs (obviously time is long for such product category), your product can be registered in Thai FDA in 1/4 weeks, just providing the necessary documents to a Thai accredited and licensed importer.

How to get a License in Thai FDA?

  1. find a Thai company with full license and registered business place. You can register your company in Thailand and get the FDA license under your own name, or you can rent a storage in bangkok and let us do it for you.
  2. provide a set of documents, variable according to the nature and classification of your product.
  3. register healthcare products you want to import through our Regulatory Services Department
  4. pay government tax (variable according to product classification), pay our professional fee and get the original license you will use for custom clearance.

Normal time is 3 weeks for the full process for medical devices and dietary supplements; 1 week for cosmetics, up to 6 months for traditional medicine, more than this for drugs. These lead time are not the standard times, but based on our direct experience. Authorization of Cosmetic Products theoretically takes two days, but it never happens…

How to Import after Registration in Thai FDA

Thai FDA Registration authorizes you to import the product according to this scheme:

  1. Send the request for import to Thai FDA
  2. Receive the approval to import from Thai FDA (technical name is LPI, License per Invoice)
  3. Apply for Custom clearance in Thai Custom
  4. Pay Duties and VAT
  5. Get the product and store it.

After this process terminates, every foreign company gets the authorization to import, promote, advertise healthcare products in the full respect of Thai law. Please note that from November 2019 Medical Devices need a proper Advertisement License issued by Thai FDA.

To know more, contact us by email or book a free 20 minutes consultancy by Skype or WhatsApp with our regulatory specialist.

Summary
Import Registration in Thai FDA
Article Name
Import Registration in Thai FDA
Description
In Thailand, a registration in Thai FDA is mandatory for any activity related to food, dietary supplements, medical devices, cosmetics, drugs and traditional medicine (chinese medicine), even for samples. See the details.
Author
Publisher Name
Siam Trade Development
Publisher Logo