Official Fees for Medical Device Registration in Thailand

Q: How much are the official registration fees in Thailand?

1. Key takeaways

Official registration fees in Thailand follow the official fee schedule published on the Thai FDA website, split into a local manufacture tier and an import tier. The schedule covers listing certificates for Class 1, notification certificates for Class 2-3, and product licences for Class 4, each composed of an application fee, a document verification fee or expert fee, and a certificate fee. The most important nuance is that the expert fee is not mandatory: it is decided case by case, charged only when the Thai FDA considers that the device needs deeper technical evaluation, typically because the technology is newer or less mature. Because of this, the actual official fees for Class 2-4 exist in two tiers, and budgeting should be done on the with-expert tier with settlement against the actual outcome. Equally important, official fees are not the main cost of a Thai project; treating them as the budget main body is the most common misjudgment.

• Two tiers per class. The schedule distinguishes local manufacture and import for every certificate type, with the import tier higher in every case.
• Expert fees are case-by-case. Class 1 never triggers them, Class 2 rarely, Class 3 sometimes, Class 4 often.
• Two possible totals for Class 2-4 imports. Without expert review, Class 2-3 import totals 11,000 THB and Class 4 import totals 21,000 THB; with expert review they reach 49,000 THB and 74,000 THB.
• Fees are per application, not per device. The more models merged into one filing, the lower the unit cost, which makes grouping the only controllable saving lever on official fees.
• Reliance saves the expert fee. The Reliance (HSA) path exempts expert review, saving about 53,000 THB.
• Official fees are not the main cost. Real project cost is driven by services, translation, dossier preparation, testing evidence, local operations and time.

2. Legal basis

The fee rates are constituted jointly by two instruments. The Ministerial Regulation on Medical Device Fees B.E. 2563 (2020) sets the application fees and certificate fees, while the MoPH Notification on Fees Collected from Applicants under Medical Device Product Licence Procedures B.E. 2564 (2021) sets the review fees, replacing the old fee schedule of 2017. The combined official rates, as published on the Thai FDA website, are shown below, with all amounts in Thai baht (THB).

The expert fee deserves separate explanation. It is not charged automatically; the Thai FDA adds it only when it considers that the device needs a deeper technical evaluation, usually because the technology is relatively new or not yet mature. The observed trigger pattern is that Class 1 never triggers it, Class 2 rarely, Class 3 sometimes, and Class 4 often. For Class 2-4 imports this produces two tiers: without expert review, Class 2-3 import totals 11,000 THB (1,000 plus 10,000) and Class 4 import totals 21,000 THB (1,000 plus 20,000); with expert review the totals are the 49,000 THB and 74,000 THB shown in the table.

3. Expert insights

Are official fees the main cost of a Thai project? No. Taking the Class 4 import total of 74,000 THB, roughly RMB 16,000, the absolute value of official fees is not high. The real total cost of a Thai project is mainly composed of licence holder and agency services, Thai translation and notarisation, CSDT dossier preparation, testing and clinical evidence, local warehousing and personnel, and time cost. Treating official fees as the budget main body is therefore the most common misjudgment, because it invites a plan that is cheap on paper and expensive in practice. On the saving side there are two levers. The first is the grouping strategy: official fees are charged per application rather than per device, so the more models that can be merged into one filing, the lower the unit cost becomes, which also means the grouping decision should be settled before dossier preparation begins, because it directly determines how many application fees will be paid. The second lever is the accelerated path: the Reliance (HSA) route exempts expert review, saving about 53,000 THB, which for a Class 4 import is more than the entire application-plus-certificate component of the fee. For budgeting purposes, the practical estimate is to plan at the with-expert tier and settle against the actual assessment outcome.

4. Practical recommendations

• Budget at the with-expert tier. Prepare the budget using the tier that includes expert fees, and settle according to the actual outcome of the assessment.
• Decide grouping before dossier preparation. The grouping strategy directly determines how many application fees you will pay, so it must be settled before the dossier is compiled, not after.
• Merge models aggressively where technically justified. Because fees are charged per application rather than per device, merging more models into one filing lowers the unit cost of market entry.
• Evaluate the Reliance (HSA) path. For eligible products, the Reliance route exempts expert review and saves about 53,000 THB.
• Do not let official fees dominate the plan. Build the budget around services, translation and notarisation, CSDT preparation, testing evidence, local operations and time cost, which is where the real money goes.
• Check the current schedule before filing. Use the fee table published on the Thai FDA website as the reference point for each filing year.

5. Verification checklist

• □ Thai FDA website For Commercial Purpose Step 5 official fee schedule (six tiers, local manufacture and import)
• □ Ministerial Regulation on Medical Device Fees B.E. 2563 (2020) (application fees and certificate fees)
• □ MoPH Notification on Fees Collected from Applicants under Medical Device Product Licence Procedures B.E. 2564 (2021) (review fees, replacing the 2017 schedule)
• □ Case-by-case expert review mechanism (Class 1 never / 2 rarely / 3 sometimes / 4 often)
• □ Official fees charged per application, not per device
• □ HSA Reliance exempts expert review, saving about 53,000 THB

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including Thailand. Our team prepares dossiers to ASEAN CSDT structure, manages submissions and deficiency responses with the Thai FDA, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com