If you want to import, manufacture, or ultimately sell goods in Thailand, then you must understand how to navigate the regulatory landscape of the Thai Food and Drug Administration (FDA) and register your products.
Whether you intend on setting up a trading company or you are planning on running local factories directly in the market, this article will be your starting point for FDA registration in Thailand.
Understanding the scope of the FDA in Thailand
How does the FDA work in Thailand?
As with many countries, the FDA in Thailand is responsible for monitoring and regulating the quality, and efficacy of consumer products that fall within its jurisdiction. The overall aim of the Agency is to protect consumers in the Thai market by conducting quality control audits and putting safety standards in place.
Suppose your company operates within one of Thailand’s FDA-regulated industries. In that case, you must ensure compliance with current regulations for any of the following business activities that involve regulated goods and products:
- Importing
- Manufacturing
- Distributing
- Advertising
Overview of FDA-regulated industries in Thailand
FDA registration in Thailand is a crucial step for getting your products approved for sale within the market. Remember that each regulated industry has its own set of criteria and procedures that must be followed. You will need to undergo the registration process if your activities fall under the following categories:
- Food / Beverages
- Cosmetics / Personal care products
- Drugs / Pharmaceuticals
- Medical Devices
- Herbal products
- Hazardous/volatile substances
While each industry is specifically regulated, you will also need to follow the correct process depending on whether your products are being imported into Thailand, or if you are setting up local manufacturing facilities. We’ll explore these two options in more detail in the next sections.
How to legally import regulated goods into Thailand
Securing an import license through FDA registration in Thailand
The Thailand FDA import license must be acquired by any foreign company that intends to bring their goods into the country for eventual distribution. This also applies to sourcing materials from another country to be used in local manufacturing operations. While the required documents to apply for an import license can vary from industry to industry, the following are mandatory:
- Application
- Affidavit
- Free Sale Certificate
- VAT Certificate
- Seal of registration
These documents will also be necessary for customs clearance once your goods arrive in Thailand. This process can be complex and requires thorough preparation to avoid delays at the port of entry. Alternatively, Emerhub can act as your consignee through our Importer of Record service, allowing you to start importing more quickly through our fully licensed logistics network.
What is a Free Sale Certificate and why do foreign suppliers need it?
A Free Sale Certificate (FSC) is essential for importing goods into Thailand. This official document is issued within the country of product origin, and its purpose is to confirm that the goods in question are legally sold in the exporting country’s local market. This is especially valuable for FDA registration in Thailand, due to the country’s strong trade agreements.
The FSC confirms that the goods meet the origin country’s regulations while providing key details about the manufacturer. This can help speed up the process of obtaining approval to import goods into Thailand, as it will give FDA authorities access to similar regulatory details from the country of origin, such as local inspection reports and manufacturing details.
How to start distributing and selling regulated goods in Thailand
FDA registration requirements for the most common regulated industries in Thailand
If you are considering setting up distribution and sale of your products in the Thai market, you will need to ensure that you provide all the required information through your application. Keep in mind that every product requires individual registration. Below you will find an overview of the required documentation for registering products within the most popular Thai industries:
| Food and Beverage | Cosmetics and personal care | Medical devices |
| – Product details (name, ingredients, composition, shelf life) – Labeling in Thai language – Manufacturer details – Facility information – FSC (for imports) – Factory Registration Certificate (if applicable) – Laboratory Analysis reports | – Product details (name, ingredients, composition, shelf life) – Labeling in Thai language – Manufacturer details – Facility information – FSC (for imports) – Certificate of analysis | – Executive summary (device description, intended use, indications, instructions, etc.) – Labeling in Thai language – Manufacturer details, letter of safety, market history – Design verification – Risk analysis report – Disposal instructions – Distribution and approval confirmation (for imports) |
Product registration through the FDA in Thailand
FDA registration in Thailand is complex and requires that you exercise proper due diligence to ensure approval and avoid delays. It is important to note that in the event that changes are brought to the registered product, you will need to inform the Agency and re-register.
Emerhub can help you with securing the right documentation for the goods you intend to distribute, as well as manage the FDA product registration process for you. Our team of local experts will help navigate product classification as well as review all of your documents to ensure application approval. We can also help protect your brand through trademark registration.
If you are interested in setting up distribution of a regulated product within the Thai market, don’t hesitate to contact us via the form below to get in touch with one of our advisors!
