3 Most Important Documents Required for FDA Registration In Thailand

The import-export business is a lucrative opportunity for foreigners. This is because it doesn’t require any permission from the Thai government. Another benefit is that you can import goods in Thailand without any strict restriction. However,there are certain goods that require prior permission from the Food and Drug Administration (FDA) in Thailand. For that, you must get the FDA import license.

FDA License Application & Approval
Image Credit: Esofosbuvir.com

The approval from the FDA depends on the following five criteria:

1.  Pre-marketing control of the specific product
2.  Post-marketing control measures such as regular checks in the facilities
3.  Supervision of consumer safety after the launch of product
4.  Accuracy of the product information
5.  Cooperation with the government agencies

Three Most Important Documents

You have to furnish a number of documents, along with the application form, to get the FDA import License. The most important of all are:

i.  A Copy of Domestic Registration:

This is important in case you are not a Thai national. Along with your application form, attach your work permit in Thailand. This work permit is issued by the Labor Department, Thailand.

ii.  A Copy of Company Registration:

Submit the documents related to the establishment of your company. These documents must contain the information related to the objectives of the company and the name of the authorized person of the company.

iii.  Authentication of the Nationality of the Company:

This document contains the list of shareholders in your company. You will get this document from the Ministry of Commerce.  In case you are a foreigner, then along with this document, you have to provide a certificate for carrying on business in Thailand.

Apart from these documents, the FDA also has specific guidelines for labeling of your products. The labels must include:

1. The name, type and category of the device (in case you are importing a medical equipment)
2.  Identity of the importer or manufacturer (name and address)
3.  Intended use of the product
4.  Storage and usage instructions
5.  License number
6.  Any warning and precautions regarding the usage of the product.

The time period for obtaining FDA registration can vary. In the case of cosmetics registration, it takes no longer than a day. On the other hand, food registrations might take as long as four months while medical device registration can take minimum six months. Consult a qualified legal firm (like us) to guide with the processes. In case you want to obtain import export license in Thailand, then get in touch with us. We will help you with the FDA registration process and make sure that your application is processed quickly and smoothly. Book an appointment with us at +66 26260277.

Tags : FDA import license, FDA import license Thailand, import export business Thailand, import export Thailand,
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