FDA Application

Thailand FDA Application

We help businesses prepare and submit Thailand FDA applications—covering product registration, licensing, labeling, and compliance requirements—so you can import, distribute, or sell regulated products in Thailand with confidence.

Who is it for / Suitable for

Importers and distributors bringing regulated goods into Thailand (e.g., food, supplements, cosmetics, medical devices).

Brands launching products that require FDA product notification/registration and compliant Thai labeling.

Manufacturers needing facility/product compliance for Thai market entry.

E-commerce sellers seeking regulatory compliance to avoid seizures, delays, or platform issues.

Key Requirements

Correct product category

Identify whether your product is food, supplement, cosmetic, medical device, or another regulated category.

Formula & ingredient review

Ingredients must comply with Thai regulations; restricted substances and claims must be handled carefully.

Thai labeling compliance

Thai label requirements vary by product type (name, warnings, ingredients, manufacturer/importer, etc.).

Local license holder (as required)

Some applications require a Thai entity as license holder/importer/distributor.

Document package preparation

Product specs, certificates, manufacturing details, and supporting claims documents (as required).

Clients need to provide the following information / documents

Document Name

Notarized

Product information & specifications

Full product details (ingredients, composition, intended use, and product variants/SKUs).

Certificates (as applicable)

COA, GMP, free sale certificate, and/or manufacturing certificates depending on category.

Sometimes

Label artwork / packaging

Existing label designs and packaging photos for Thai labeling review and edits.

Company registration documents (if applicable)

Thai company affidavit, shareholder list, and authorization documents for filings (where needed).

Power of Attorney (if filing via agent)

Authorization for us to submit and coordinate with Thai FDA on your behalf.

Yes (if required)

Average Processing Time

10–45 working days

Category & eligibility check: 2–5 days
Document preparation & label review: 3–10 days
Thai FDA review & approval: 5–30 business days
Timing varies by product category and completeness of documents.

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What you would get when the application is complete

FDA registration/notification outcome

Official registration/notification number or approval documentation (depending on category).

Compliant label guidance

Recommended Thai label content and compliance checks for claims and warnings.

Submission record & receipts

Filing confirmations and supporting record trail for audits and future renewals.

Next-step roadmap

Clear next steps for import clearance, renewal timelines, and ongoing compliance.

On-going Compliance Requirements

After approval, ongoing compliance typically includes:

Maintain compliant labeling & claims

Ensure labels, marketing claims, and online listings stay within Thai FDA rules.

Track renewals/changes

Update the FDA if product formula, packaging, importer, or manufacturing details change.

Keep records for inspections

Maintain certificates, COAs, and registration documents for inspections and audits.

Import compliance alignment

Ensure customs declarations align with registered product details to avoid clearance issues.

Government Agencies Involved / Overseeing the Application

These authorities may be involved in FDA approvals and related compliance:

Thai Food and Drug Administration (Thai FDA)

Primary regulator for food, supplements, cosmetics, medical devices, and related products.

Thai Customs Department (as applicable)

May request FDA approvals/registrations for import clearance of regulated goods.

Other regulators (as applicable)

Depending on product type, additional agencies may apply (e.g., TISI standards, NBTC for certain devices).

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Consult With Our Corporate Advisory Team

Our team is ready to guide you through the full process. Reach us on WeChat or WhatsApp.