During medical device registration in Thailand, whether a Class 2 to Class 4 device attracts a technical review fee depends on the technical documentation evaluation route selected for the application, and on whether the submission must be referred to an external expert or recognised body appointed by the Thai FDA for evaluation.
Sources: Thai FDA medical device official fees page (medical.fda.moph.go.th/non-ivd-head/general-expense) | Thai FDA IVD official fees page (medical.fda.moph.go.th/ivd-head/ivd-06-01)
1. Registration Routes and Official Fees
| Risk Class | Registration Route | Application Fee | Technical Review Fee | Authorisation Fee | Total |
| Class 1 | Listing (listing / filing) | THB 500 | / | THB 2,000 | THB 3,100 |
| Class 2, 3 | Detailed Notification | THB 1,000 | THB 38,000 | THB 10,000 | THB 49,000 |
| Class 4 | Licence | THB 1,000 | THB 53,000 | THB 20,000 | THB 74,000 |
Technical review fees are also charged on changes to imported devices:
| Change Type | Application Fee | Technical Review Fee | Total |
| Class 2, 3 — Major Change | THB 500 | THB 24,000 | THB 24,500 |
| Class 4 — Major Change | THB 500 | THB 30,000 | THB 30,500 |
| Class 2–4 — Minor Change | THB 500 | / | THB 500 |
2. Evaluation Channels (Technical Documentation Routes)
The CSDT documentation routes listed on the Thai FDA website include:
| Evaluation Channel | Basic Meaning |
| Full evaluation | Complete CSDT technical documentation is submitted as prescribed. |
| Abridged evaluation | Where the conditions for approval in a reference country are met, part of the documentation may be exempted and duplicated review reduced. |
| Reliance Program | The Thai FDA conducts review by relying on the evaluation results of other regulatory agencies. Currently this mainly covers Evaluation Reports issued by Singapore HSA and obtained by the Thai FDA. |
3. Evaluating Bodies and When a Technical Review Fee Arises
After an application is submitted, the technical documentation may be evaluated by either of the following:
• Thai FDA internal reviewers;
• external experts, expert bodies or review organisations listed or recognised by the Thai FDA.
Where external expert evaluation is required, a technical review fee is payable. The general rule and the exemptions are set out below.
3.1 Situations Requiring External Expert Evaluation
Under the criteria published by the Thai FDA, the following products generally require submission of complete documentation and evaluation of performance and safety by external experts, and attract a technical review fee:
| # | Category | Description and Examples |
| 1 | Devices using new technology | Innovative products not previously seen in Thailand, including artificial intelligence (AI) medical devices. |
| 2 | Devices switched from professional hospital use to home use | Where the place of use changes from a hospital to the home and the user changes from a healthcare professional to the general public. Examples: laser products for hair growth; red LED products for reducing wrinkles; other phototherapy products (excluding blue light products for acne treatment). |
| 3 | Devices that experts consider require further evaluation of performance and safety | Examples: products without hyaluronic acid intended to repair skin defects; poly dioxanone (PDO) threads, gold threads and similar products intended to lift the skin; products used to collect human cells and reinfuse them into the body, such as platelet-rich plasma (PRP) and stem cell-related products. |
| 4 | Devices with a record of serious safety risk | Products that have experienced a Serious Adverse Event, or that have deficiencies or performance issues that may result in serious adverse reactions to the medical device. |
| 5 | Products subject to specific announcements by the Thai Ministry of Public Health | Products regulated under specific Ministry announcements. |
Source: Circumstances in which documentation on the safety and performance of medical devices must be submitted for external expert evaluation | medical.fda.moph.go.th/product/category/criteria-expert-pre
3.2 Major Changes After Approval
After a product has been approved, where changes are made to the intended use, key design, performance, materials, sterilisation method or manufacturing site, and the change is classified as a Major Change requiring re-evaluation of safety, performance or compliance, a technical review fee is payable. The fee is assessed on the basis of the specific content of the change.
4. Situations Where No Technical Review Fee Is Payable
4.1 Products Designated for Internal Review
Where a product has been designated for evaluation by Thai FDA internal reviewers, it does not in principle need to be referred to an external expert. However, if doubts arise during internal review as to the safety or performance of the product, it may still be further referred to an external expert, in which case a technical review fee is payable.
4.2 Recognised Reference Agencies and Applicable Conditions
The following agencies are recognised by the Thai FDA:
| # | Recognised Reference Agency |
| 1 | Australia — TGA |
| 2 | Canada — Health Canada |
| 3 | European Union — Notified Bodies |
| 4 | Japan — Ministry of Health, Labour and Welfare |
| 5 | United States — FDA |
| 6 | World Health Organization (WHO) — Prequalification of in vitro diagnostic products |
| 7 | Singapore — HSA, under the Thai FDA reliance programme |
Approval by a recognised reference agency must also meet the following conditions:
• the approval is based on an evaluation of safety and performance, and does not take the form of an exemption from evaluation;
• except for the Singapore HSA reliance programme, the approval must have been in place for at least one year;
• the product submitted in Thailand must be consistent with the approved overseas product in intended use, indications, labelling, instructions for use and packaging.
Where a product has already been registered in Singapore and the Singapore registrant is able to issue a letter of authorisation allowing the Thai FDA to obtain the technical review report issued by HSA, the regulatory reliance review route may be applied for.
Products meeting these conditions may apply for abridged evaluation, with partial exemption from documentation and reduced duplicated review, so that no technical review fee is payable. The Thai FDA nevertheless notes that, where there are doubts concerning the quality standards, performance or safety of a device, officers will require the applicant to supply additional documentation to ensure the effectiveness and safety of the approval process.
Sources: Thai FDA abridged evaluation guidance (medical.fda.moph.go.th/press-release/enewslettervol6) | Thai FDA announcement on recognised foreign agencies for medical device / premises inspection and certification results (B.E. 2567), medical.fda.moph.go.th/relevant-laws-and-standards/list-of-foreign-agencies
4.3 Reference to Existing Registration Documentation
In 2024 the Thai FDA issued guidance on the reference of existing registration documentation, the transfer of documentation, and other circumstances in which technical evaluation by a Thai FDA-listed review body is not required in connection with applications for a manufacturing or import licence and for detailed notification applications (B.E. 2567). Three categories of application may rely on an already-approved master file without further evaluation by a Thai FDA-recognised external expert or review organisation, and therefore do not attract a technical review fee.
| # | Category | Conditions to Be Satisfied |
| 1 | New brand name | Conditions:** the referenced documentation must be a complete master file; the consent of the original certificate holder must be obtained; a product safety declaration and a consistency declaration must be submitted; the intended use, manufacturing process, composition, performance and control standards of the new and original products must be consistent; imported products must be manufactured by the same manufacturer and belong to the same product owner; and the original registration certificate and business premises registration must remain valid. |
| 2 | Transfer of documentation on change of importer | Conditions:** the registration file to be transferred must be complete; where the original file benefited from a partial documentation exemption, the outstanding documentation must first be completed; the consent of the original importer to transfer the documentation must be obtained; a safety declaration and a consistency declaration must be submitted; the product name, model, product code, intended use, manufacturing process, composition, performance and control standards must remain consistent; the manufacturing site and product owner must remain unchanged; and the original import registration certificate must remain valid. |
| 3 | Transfer of documentation on change of Thai local manufacturer | Conditions:** the original registration file must be complete; where the original file benefited from a documentation exemption, the outstanding documentation must first be completed; the original manufacturing enterprise must consent to transfer the documentation to the new manufacturing enterprise; a safety declaration and a consistency declaration must be submitted; the product name, model, product code, intended use, manufacturing process, composition, performance and control standards must remain consistent; the actual manufacturing address must remain unchanged; and the original product registration certificate must remain valid. |
Even where an application qualifies for reference or transfer of documentation, if the product has experienced a Serious Adverse Event, has performance deviations or deficiencies that may result in a serious adverse event, or where there are reasonable doubts as to its quality, performance or safety, the application may be referred to an external expert for further evaluation, and a technical review fee will then be payable.
Source: Guidance on the reference of existing registration documentation, transfer of documentation and other circumstances not requiring technical evaluation by a Thai FDA-listed review body (B.E. 2567) | medical.fda.moph.go.th/product/refer-page
5. Practical Considerations for Companies
- Select the evaluation route early. The choice between full evaluation, abridged evaluation and the reliance programme determines whether a technical review fee is payable, and is best made at the pre-submission stage.
- Check the reference-agency conditions before relying on an overseas approval. Confirmation is needed that the overseas approval was based on an actual safety and performance evaluation, that it has been in place for at least one year (except for the Singapore HSA route), and that the Thai product matches the approved overseas product.
- Watch the change classification. Changes to intended use, key design, performance, materials, sterilisation method or manufacturing site may be classified as Major Changes, attracting a technical review fee of THB 24,000 to THB 30,000 depending on class.
- Safety history can override any exemption. A history of serious adverse events, or reasonable doubts as to quality, performance or safety, is sufficient for an application to be referred to an external expert even where it otherwise qualifies for abridged evaluation, reliance or documentation reference.
- Budget the fee into the registration plan. At the top of the range, a Class 4 licence carries a total official fee of THB 74,000, of which THB 53,000 is the technical review component.