Thai Fda Registration
Thai FDA Cosmetic Registration

Ensure your cosmetics meet Thailand's regulatory standards with our expert Thai FDA registration services. We offer fast, efficient, and fully online solutions, guiding you through every step for smooth market entry and compliance.

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A cosmetic product under Thai FDA regulations refers to any substance or preparation intended for application to the human body for cleansing, beautifying, promoting attractiveness, or altering appearance. This includes a wide range of items such as creams, lotions, perfumes, makeup, hair care products, deodorants, and other personal care products. Cosmetics are designed for external use on the skin, hair, nails, or lips and are not meant to affect the structure or functions of the body through chemical or metabolic processes. Instead, they work on the surface to enhance or maintain appearance and hygiene. Compliance with Thai FDA regulations ensures these products are safe, properly labeled, and suitable for use in the market.

Low-Risk Cosmetics Registration 

Low-risk cosmetics, such as basic skincare and makeup products, go through a relatively quick notification process. The manufacturer or importer must prepare and submit required documents, including a product dossier, label samples, ingredient lists, and intended usage details. If all documentation is in order, the notification process typically takes 7 to 14 working days. However, any errors in the submission can delay approval, highlighting the importance of accuracy.

  • Document Preparation: Compile all necessary details, including ingredient lists, label drafts, and intended product use.
  • Submission to Thai FDA: Upload the documents through the Thai FDA online portal.
  • Review and Approval: The Thai FDA reviews the submission, verifying compliance with regulations. If no corrections are needed, approval is typically granted within 7 to 14 working days.
  • Post-Approval Compliance: Once approved, ensure that the product’s packaging and labeling match the registered details to avoid issues during post-audit inspections.

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    High-Risk Cosmetics Registration

    For high-risk cosmetics, such as those with active ingredients or therapeutic claims, the registration process involves additional steps. Companies must provide detailed safety assessments, efficacy studies, and ingredient certifications. Thai FDA reviewers may require further clarification or testing results, extending the timeline. On average, high-risk cosmetic registration can take 20 to 30 working days, depending on the product's complexity and the completeness of the submission.

  • Safety and Efficacy Data Collection: Prepare detailed reports, including safety assessments, efficacy studies, and ingredient certifications.
  • Document Submission: Submit a full dossier through the Thai FDA online system, ensuring all forms are completed accurately.
  • Thai FDA Review: The agency may request additional information or clarification. This phase can take 20 to 30 working days, depending on the product complexity and the submission quality.
  • Approval and Implementation: Upon approval, confirm that the final product matches the registered details in all aspects.

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    Thai FDA Cosmetic Post Audit

    After registration and market entry, the Thai FDA performs a post-audit process to ensure compliance. This involves random checks of registered products to verify that the packaging, labeling, and formulation match the approved details. The post-audit process does not have a set timeline, as inspections are conducted periodically and without prior notice. Non-compliant products are subject to regulatory actions such as fines, recalls, or license suspension..

  • Random Inspections: The Thai FDA selects registered products for review without prior notice.
  • Document Verification: Officials compare submitted details with the product’s packaging, labeling, and formulation.
  • Compliance Actions: If discrepancies are found, the manufacturer or importer may face penalties, recalls, or suspension of licenses. Maintaining precise records and ensuring consistency is critical.

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