Class 1 Medical Device Listing in Thailand: Requirements, Fees and Auto-Approval

How does a Class 1 medical device reach the Thai market? It goes through the Listing pathway: the manufacturer or its authorised representative submits an application to the Thai FDA and receives a Certificate of Listed Medical Device. Among the three approval routes in Thailand, Listing carries the lowest degree of regulatory control, because Class 1 devices are considered to present the lowest potential risk to patients and users.

1. Key takeaways

The Listing route is document-based and comparatively light, but light does not mean effortless. The points below summarise what determines whether a Class 1 listing in Thailand moves smoothly or stalls.

• Class 1 devices enter Thailand through the Listing pathway and receive the Certificate of Listed Medical Device. This is the lowest-control route of the three pathways in the Thai system.
• Since January 2025 (official announcement; industry sources record January 15, 2025), qualifying Class 1 devices that appear on the Thai FDA Positive List are auto-approved after e-Submission and fee payment, with no human review. The Positive List identifies devices by GMDN code.
• Class 1 devices outside the Positive List, and Class 1 devices with a measuring function, still follow regular document review, which typically takes about 4 months.
• The Class 1 document set follows the checklist published on the Thai FDA website and is built around labelling, the instructions for use, specifications, device description, materials, the declaration of conformity and the letter of authorisation. Sterile devices additionally need sterilisation reports, and devices with a measuring function need calibration reports.
• Class 1 does not require an ISO 13485 certificate (only Classes 2-4 do), but manufacturers must still follow the Thai GMP guidance.
• Official fees for the import route are: application fee 500 + document verification fee 600 + certificate fee 2,000, totalling 3,100 Thai baht. For local manufacturing the total is 500 + 300 + 1,000 = 1,800 Thai baht. Class 1 attracts no expert review fee.
• For home-use devices, the label and the instructions for use must be in Thai, and the application forms must also be in Thai under the labelling notification B.E. 2568.

2. Legal basis

The Class 1 submission set is defined by the Class 1 checklist published on the Thai FDA website. The items and their applicability are as follows.

The underlying framework is the MoPH classification notification B.E. 2562 (2019), which assigns devices to the four risk classes, together with the MoPH labelling notification B.E. 2568 (2025), which governs language requirements for labels and instructions for use, including the Thai-language obligations for home-use devices. The fee levels come from the fee schedule published on the Thai FDA website, and the auto-approval mechanism for Positive List devices derives from the official announcement of January 2025. Note again that Class 1 does not need an ISO 13485 certificate — that obligation begins at Class 2 — but Class 1 manufacturers must nevertheless comply with the Thai GMP guidance (see article 23 for detail).

3. Expert insights

Three issues account for most of the trouble seen in Class 1 projects. First, assuming that low risk means low requirements. Sterile Class 1 devices and Class 1 devices with a measuring function require additional sterilisation or calibration reports, and teams that discover this late lose time assembling them. Second, the Thai-language requirement for home-use devices. For home-use devices the label and the instructions for use must be in Thai, and the application forms must also be in Thai under B.E. 2568. Third, assuming that the absence of an ISO 13485 certificate means no quality system obligations. Although Class 1 is exempt from certification, manufacturers must still comply with the Thai GMP guidance, and that compliance expectation is real even though no certificate is filed with the listing.

Another point worth internalising is the nature of the auto-approval mechanism. It is not a general fast lane for everything in Class 1; it applies specifically to qualifying devices on the Positive List, identified by GMDN code, submitted through e-Submission with the fees paid. Everything outside that list — including measuring devices — remains in the regular document review stream of roughly four months. The practical consequence is that two otherwise similar Class 1 devices can follow dramatically different timelines depending on one administrative detail: whether the GMDN code falls inside the list.

4. Practical recommendations

• Check early whether the product qualifies for the Positive List. Confirming that the GMDN code is on the list can compress the review from several months to automatic approval, and this single check offers the highest return on effort of any verification in a Class 1 project.
• Budget realistically. The most common budgeting error in Class 1 projects is equating low official fees with low project cost. The dominant costs are usually Thai-language localisation (for home-use devices) and licence holder services, not the 3,100 or 1,800 baht in government fees.
• Prepare sterilisation and calibration reports in parallel whenever the device is sterile or has a measuring function, rather than treating them as an afterthought once the reviewer asks.
• Prepare the regulatory approval history document if approvals exist in other markets, since the checklist accepts it when available and it can support the file.
• Use e-Submission for the filing, and remember that payment must be completed for auto-approval to take effect on Positive List devices.
• Do not skip GMP alignment simply because no ISO 13485 certificate is required; the Thai GMP guidance still applies to Class 1 manufacturing.

5. Verification checklist

• □ Thai FDA website Class 1 document checklist and fee schedule (import 3,100 baht / local 1,800 baht)
• □ Thai FDA Class 1 auto-approval announcement (January 2025) and the Positive List (identified by GMDN code)
• □ MoPH classification notification B.E. 2562 (2019)
• □ MoPH labelling notification B.E. 2568 (2025) and the Thai-language requirement for home-use devices
• □ Thai FDA GMP guidance (Class 1 is exempt from certification but must comply)

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