Thailand FDA Registration.
Obtain FDA approval Professional & efficient
Thailand FDA registration is essential for importing food supplements, cosmetics, and health products into Thailand. At WELLION, we provide professional, compliant registration services to help your products enter the Thai market legally and efficiently.
Medical Devices
We register medical device with an added value: the license holding service. If you are a foreign company looking for a distributor, we register your products quickly. Or, if you are not willing to open a local unit, we register your products quickly. We support you in the import and distribution process. We can license medical devices in all 4 classes and take care of your compliance.
Dietary Supplements
Dietary supplement registration in Thai is the most engaging process for regulatory companies. Controls on formulas, ingredients and standards are stringent, and risk of failure without a proper knowledge is high. We have a 100% success rate in this category. Dietary Supplement market in Thailand is one of the most profitable in the world, due to a high internal consumption.
Cosmetics
Registration of Cosmetic Products seems to be easy and fast. It may be if documentation is correct and if you can satisfy all the requirements for your registered business place. According to new rules, you will need safety measures. You will also need trained staff and many other details. These requirements can make your experience long and expensive. We offer a one-stop-service that includes everything!
Hazardous Substance
Hazardous substance registration is required for importing chemical products, cleaning agents, and other hazardous items into Thailand. We provide comprehensive support. This includes product classification, document submission, and obtaining approval. We ensure your hazardous products meet all legal requirements before import.
Other Service
Products Assessment
Our expert team conducts in-depth assessments to ensure your products meet the stringent requirements set by the Thai FDA. Trust us to navigate the regulatory landscape, providing a clear path to market entry.Our team conducts thorough feasibility assessments, considering regulatory requirements and potential challenges, helping you make informed decisions.
Alcoholic Beverages Registration
Thailand is a main importer of Alcoholic beverages from foreign Countries, specifically wine and liquors from Europe. Compliance with alcoholic beverage labeling regulations is crucial for market access. Our Alcoholic Beverage Registration services cover comprehensive assessments to ensure your alcoholic beverages meet all required standards. We support your projects in Alcoholic beverage import.
Product Labels & Manuals
All food and ingredients must be registered before being sold on the market. Categories are multiple, from ready-to-eat to special food. An accurate and compliant food labeling is crucial for market success. Our services include thorough food labeling assessments, ensuring your products meet regulatory standards and provide clear information to consumers..
Thailand FDA License Holing Solution
With Wellion as a neutral agency, you can authorize us as your license holder and importer to ensure business advantages.
Register Thailand FDA, You have two options
1. Register your own Thai company
- Suitable for planning a business entity in Thailand.
- Register import qualifications and products under your own Thai company.
- Manage licensing, importing and sales under your own company name.
2. Appoint WELLION as your license holder and importer
- Legal to import and sell in Thailand
- No need to register and operate a company
- Applicable to operating cross-border stores abroad.
- Can find Thai distributors and sell directly to them.
- Fully protect your trade secrets and intellectual property
Thailand FDA License holding general procedure
Step 1
Registered Business Place
The first step for FDA Products Registration is obtaining the “import license.” This license must point to a “registered business place” located in a Thai FDA-authorized warehouse. This means that you have to rent and bring up to a standard a warehouse in Thailand. With our License Holding program, you no need to do it, you will use our venue.
Step 2
FDA Import License
As your Thai license holder WELLION will be indicated as Importer of your products in Thailand. We will perform all the Custom Procedures (LPI – License per Invoice, clearance and tax paying process). These procedures will be done in your name. WE are fully accredited and have all the authorization for Healthcare products.
Step 3
Specific Product License
Your Products shall be registered under our licenses. We’ll follow all the process until we get the Healthcare Product Registration in Thai FDA. We will sign a contract. It will state that you will be the owner of the product and of Intellectual Property. We will act simply as your local representative for Compliance and Storage.
Compliance Policy News
Latest News
We deal with authorities almost every week. We keep our website updated to ensure you don’t miss out on the latest regulatory changes.
Don’t know how to start？
Schedule a 30-minute virtual meeting or conference call to discuss further with us
Dylan Guo, Wellion Director and Project Operation Supervisor
FAQ
What is the role of an FDA License Holder in Thailand?
A License Holder in Thailand is responsible for holding the registration of the product under their name. They ensure compliance with all regulatory requirements. They are legally accountable for the product’s safety and quality, including managing the registration process, renewals, and any required updates.
What documentation is required for FDA registration in Thailand?
he required documents typically include a Certificate of Free Sale and Good Manufacturing Practice (GMP) certification. They also include product labels, ingredient lists, and detailed product information. Additional documents may be needed depending on the product category (e.g., food, cosmetics, medical devices).
What are the risks if my product’s FDA registration lapses or is not renewed on time?
If FDA registration lapses or is not renewed, your product can no longer be legally sold in Thailand. This can lead to penalties, including fines, product seizures, and potential legal action. Additionally, you may need to restart the entire registration process, which can be time-consuming and costly.
What happens if there are changes to my product’s formulation after it is FDA registered?
Significant changes to the product’s formulation, packaging, or intended use must be reported to the FDA. An amendment to the existing registration may be required. The FDA License Holder will need to manage this process to ensure continued compliance.
Can I hold the FDA registration for my product if I’m not based in Thailand?
No, foreign companies cannot directly hold FDA registration in Thailand. You must appoint a local representative or partner. This could be an FDA License Holder. They will manage the registration and compliance on your behalf.
How long is the FDA registration valid in Thailand, and what is the renewal process?
FDA registration in Thailand is generally valid for 3 to 5 years, depending on the product type. The renewal process requires re-submission of certain documents, including any updates to the product. This must be completed before the expiration of the current registration to avoid any disruption in market access.
Can I change my FDA License Holder after the product is registered?
Yes, you can change your FDA License Holder. However, the process involves transferring the registration to the new holder. This transfer requires approval from the Thai FDA. This may involve submitting new documents and possibly undergoing a re-evaluation of the product.
How does the FDA License Holder manage post-market surveillance and reporting?
The FDA License Holder is responsible for monitoring the product once it is on the market. This includes handling any adverse event reports, product complaints, or recalls. They must ensure that any issues are reported to the FDA and managed according to Thai regulatory requirements.