Thailand TFDA

Health and Cosmetics

Registration Procedures

Introduction

The Thailand Food and Drug Administration (TFDA) oversees the regulation and registration of health and cosmetic products. All products intended for sale in Thailand must comply with TFDA requirements to ensure safety, efficacy, and quality.

Step-by-Step Registration Procedure

1. Product Classification

Identify the product category under TFDA regulations. This includes cosmetics, health supplements, or medical devices. The classification determines the required documents and approval process.

2. Document Preparation

Prepare all necessary documents, including:
- Certificate of Free Sale (CFS) from the country of origin
- Product formula details
- Labels and packaging information
- Manufacturing process description
- Safety and efficacy data

3. Local Representation

Appoint a local representative or distributor in Thailand. This representative must have the authority to submit applications and handle regulatory matters with the TFDA.

4. Online Registration

Submit the registration application through the TFDA’s e-submission system. Create an account, upload the required documents, and pay the applicable fees.

5. Product Evaluation

The TFDA reviews the submitted documents and evaluates the product for compliance with regulations. This process may include safety tests and inspections.

6. Approval and Notification

Upon successful evaluation, the TFDA issues an approval or notification number. This number must be displayed on the product packaging before distribution.

Timeframe and Fees

The registration process can take anywhere from 1 to 6 months, depending on the product type and completeness of documentation. Fees vary based on the product category and the evaluation process.

Compliance and Monitoring

After approval, manufacturers and distributors must comply with ongoing TFDA regulations, including periodic reporting and quality control inspections. Non-compliance may result in penalties or product recalls.