Thai FDA License — Food, Drug, Cosmetic, Medical Device, Supplement

Company, BOI & accounting reference — 37 answers

Compiled from Department of Business Development (DBD), Revenue Department, BOI and DIP requirements as cited on each service page. Government fees are set by those authorities and passed through at cost.

• Q12078. Thai FDA License — Food, Drug, Cosmetic, Medical Device, Supplement — what does the service cover?

  Full Thai FDA licensing for every product family: food and beverages (Sor.Bor.5), dietary supplements, cosmetics (notification under the 2015 Cosmetic Act), medical devices (Class I–IV), and traditional or modern pharmaceuticals. We handle GMP factory registration, Thai-language labelling, and on-site inspections. quoted on request per SKU. Sources: https://www.fda.moph.go.th/ , https://www.fda.moph.go.th/en/

• Q12080. How much does Thai FDA License cost and how long does it take?

  From quoted on request per item; turnaround 30–120 days by category. Government fees are set by the issuing authority and passed through at cost.

• Q12088. Which products require FDA registration?

  Food, drugs, cosmetics, medical devices, hazardous substances, psychotropic substances, dietary supplements, and herbal products all require registration.

• Q12089. Do cosmetics need a license or just notification?

  Under the Cosmetic Act B.E. 2558 (2015), cosmetics use a Notification system via e-Submission (3–7 business days). The Notification Number must appear on the label.

• Q12090. Is a GMP-certified factory required?

  For domestic manufacturing: yes (food, drug, cosmetic). For imports: a Certificate of Free Sale (CFS) and Certificate of Analysis (CoA) from the country of origin are required.

• Q12091. How do Medical Device Classes I–IV differ?

  Class I: low risk (bandages) — notification. Class II: low-medium (thermometer). Class III: medium-high (X-ray). Class IV: high risk (implants, IVF).

• Q12092. What are the FDA fees?

  Vary by category: cosmetics quoted on request; generic drug quoted on request +; medical device quoted on request. Our fee includes government charges.

• Q12093. Must labels be in Thai?

  Yes, 100% Thai. Food labels must show product name, FDA number, ingredients, manufacture and expiry dates, net weight, and warnings if any. We prepare and vet labels.

• Q12094. How long does approval take?

  Cosmetics 3–7 days; general food 30–45 days; supplements 60–90 days; Class I medical device 30 days, Class IV 120+ days; modern pharmaceuticals 6–12 months.

• Q946130. What are the end-to-end steps for fda license?

  We start with a document and fact review, prepare and verify the file, submit to the Department of Business Development (DBD) and the licensing agencies, follow up on any queries raised by officials, and hand over the completed result with a full copy set. For fda license a case manager tracks every stage and reports status. Call +66 83-249-4999 · LINE @NYCLI · nyclegal@ilc.ltd

• Q946132. Which documents are required for fda license?

  The baseline set is the applicant's ID or passport, the original documents relating to fda license, proof of connection (house registration, company affidavit or the underlying contract) and a power of attorney if a representative attends. The exact list follows the Department of Business Development (DBD) and the licensing agencies requirements on the filing date; we send a case-specific checklist before your appointment.

• Q946134. How long does fda license take?

  Timing depends on the Department of Business Development (DBD) and the licensing agencies queue, how complete your file is, and public holidays. Our own preparation usually takes a few business days; the official stage is an estimate that can shift. We give you a realistic fda license timeline before starting and update you as it progresses.

• Q946136. What costs are involved in fda license and how are they calculated?

  There are two components: official government fees passed through at the published rate, and our professional fee, which depends on scope, document volume and urgency of fda license. Fees are quoted case by case based on complexity and document volume — ask our team before work starts. You always receive a written breakdown before work begins — no hidden charges.

• Q946138. Can fda license be handled if I live upcountry or overseas?

  Yes. Send photos of your documents via LINE for a feasibility check, then we proceed under a power of attorney, or you sign at a Royal Thai Embassy/Consulate where you live and courier the originals back. For fda license we map out the fastest and safest option before you commit.

• Q946140. What are the most common mistakes in fda license and how do we prevent them?

  The usual causes of rejection are name spellings that differ between documents, documents that expire before the filing date, uncertified copies, and translations that do not match the original. the Department of Business Development (DBD) and the licensing agencies returns files for exactly these reasons, so we cross-check names, dates and seals across every page before submitting fda license.

• Q946142. Which laws or regulations govern fda license?

  The framework is set by the Civil and Commercial Code, the Foreign Business Act B.E. 2542 and the applicable tax legislation, together with the regulations and notifications issued by the Department of Business Development (DBD) and the licensing agencies, which are revised from time to time. Before advising on fda license we verify the version in force on the filing date and rely on official sources rather than second-hand summaries.

• Q946144. What happens if fda license is rejected or returned for correction?

  First we obtain the written reason from the Department of Business Development (DBD) and the licensing agencies, then separate formal defects (fixable and quickly refiled) from substantive or eligibility issues (which need a change of approach). Where the error is ours, we redo fda license at no extra professional fee and coordinate until the matter is resolved.

• Q946146. Who is fda license for, and what are the eligibility conditions?

  It suits anyone who must present the result of fda license to a government body, bank, educational institution or overseas counterparty. Applicant eligibility and supporting documents follow the Department of Business Development (DBD) and the licensing agencies rules; some cases require the document holder in person or a properly executed power of attorney. We screen eligibility free of charge before accepting the case.

• Q946148. How long does the result of fda license stay valid?

  Certified documents rarely carry an expiry date themselves, but most receiving authorities require issuance within 3–6 months of submission, and some are stricter. Check the destination's rule before starting fda license so nothing has to be redone; we plan the sequence around your filing deadline.

• Q946150. Does fda license also need an English or target-language translation?

  If the receiving body is overseas, a certified translation is normally required, and many countries insist on their own official language rather than English. We confirm the destination rule first, then produce a translation aligned with fda license and certify it in the same workflow to avoid extra rounds.

• Q946152. Should I handle fda license myself or use a service provider?

  Doing it yourself saves the professional fee but leaves you carrying the risk on document format, queueing and travel time, plus shifting the Department of Business Development (DBD) and the licensing agencies practice. A provider reduces rejection loops and gives you someone accountable for follow-up. For fda license we are happy to give initial guidance even if you proceed on your own.

• Q946154. Is there an express option for fda license?

  We can prioritise our own preparation subject to capacity, but any stage controlled by the Department of Business Development (DBD) and the licensing agencies follows official procedure and cannot be guaranteed to a fixed date. We tell you plainly what the fastest realistic fda license window is and offer alternatives if your deadline is too tight.

• Q946156. How is my data protected when you handle fda license?

  We process personal data under Thailand's Personal Data Protection Act B.E. 2562 (PDPA), use it only to carry out fda license as instructed, restrict access to the assigned team, and return or destroy originals on your instruction. You may exercise access or deletion rights at any time.

• Q946158. What happens after fda license is completed?

  Check names, dates and seals as soon as you receive the result of fda license, keep at least one digital copy, and submit to the receiving authority within its validity window. If the destination requires further legalisation — for example the Department of Consular Affairs or an embassy — we continue the chain in the same engagement.

• Q946160. What risks should I know before starting fda license?

  The main risks are destination rules changing mid-process, historic documents that no longer match current facts, and deadlines so tight that no correction round is left. We confirm requirements with the Department of Business Development (DBD) and the licensing agencies or the receiving body before filing fda license and build correction time into the plan.