What Is Thailand FDA (อย.)? Which Products Require Approval?

Emory Views: 832 2026-06-22 12:36:41 Comments: 0

About TMA Group
TMA Group is a professional company focusing on local recruitment and corporate consulting in Thailand, dedicated to providing one-stop services including recruitment, financial management, tax disposal, legal consulting, personnel management, etc. for enterprises and individuals. If you need more advice on investment in Thailand, please feel free to contact us.

—— TMA GROUP ——

TMA GROUP

FDA-Related Questions

Does Your Product Require Thailand FDA (FDA Thailand / อย.) Approval?

When entering the Thai market, one of the most common questions is:

Does my product require Thailand FDA (อย.) approval?

In Thailand, products related to health and safety are generally subject to regulatory control.

Incorrect assessment may not only affect product sales and market entry, but could also result in regulatory violations.

Therefore, understanding the scope of Thailand FDA regulation is the first step toward compliant market entry.

First Category: Food and Beverages

Including:

• Ready-to-eat food
• Canned food
• Drinking water
• Dietary supplements
• Vitamins

These products fall under key regulatory categories and generally require:

👉 Obtaining an FDA registration number (อย. number)

👉 Product labels must be in Thai language

Particularly for health supplements and functional foods, the review process is usually more stringent.

Second Category: Cosmetics

Including:

• Face creams
• Serums
• Shampoos
• Body wash and other personal care products

Thailand implements a notification system for cosmetics.

👉 Product notification must be completed before sale.

👉 Even products sold through cross-border e-commerce channels must comply with local regulations.

Third Category: Pharmaceuticals, Medical Devices, and Related Products

Including:

• Pharmaceuticals (modern medicines and traditional medicines)
• Medical devices (such as masks and diagnostic test kits)
• Herbal products, disinfectants, pesticides, etc.

👉 These are highly regulated product categories.

They generally require a more comprehensive approval process and qualification review.

In practice, common misconceptions among businesses include:

👉 Assuming that only food products require FDA approval

👉 Overlooking the importance of Thai-language labeling

👉 Believing that cross-border e-commerce is exempt from local regulations

👉 Selling products before completing notification or registration

These situations may lead to significant compliance risks in the future.

Summary

Understanding whether a product falls within the scope of Thailand FDA regulation is essential before entering the Thai market.

Proper compliance planning at an early stage can help businesses avoid regulatory risks and ensure smoother market access.

END

YouTube

Disclaimer

TMA Consulting Management has been paying attention to the updating of information through newsletters for many years, but we do not assume any responsibility for the completeness, correctness or quality of the information provided. No information contained in this article can replace the personal consultation provided by a qualified lawyer. Therefore, we do not assume any liability for damages caused by the use or non-use of any information in this article (including any kind of incomplete or incorrect information that may exist), unless it is caused intentionally or by gross negligence.