Class 1 GMP and Documentation Requirements in Thailand

1. Key takeaways

Class 1 in Thailand is frequently misread. The accurate statement is that the route is light but the requirements are not: Class 1 is exempt from quality system certification, but not from the GMP requirement itself. According to the Thai FDA interpretation, manufacturers of low-risk devices are exempt from the certification requirement, yet they must still upgrade facilities and establish a quality system that meets the updated GMP standard. The same logic runs through the whole dossier: a simplified document list applies, but the items that do apply, such as sterilisation reports for sterile devices and calibration reports for devices with measuring functions, are mandatory in full.

• Class 1 does not submit an ISO 13485 or GMP certificate, while Class 2-4 must submit one.
• Class 1 must still establish a quality system conforming to the GMP standard, exactly as Class 2-4 must.
• Class 1 uses a simplified document set instead of the complete CSDT dossier that Class 2-4 must compile.
• Class 1 does not incur expert review fees, while Class 2-4 may incur them.
• Sterilisation reports apply to Class 1 only for sterile devices; calibration reports apply only to devices with measuring functions.
• Class 1 labelling and IFU for home-use devices must be in Thai under B.E. 2568, defect and adverse event reporting under B.E. 2563 applies to Class 1 like every other class, and renewal must go through SKYNET in the annual October to December window, with late renewal closing the import channel just as it does for higher classes.

2. Legal basis

The distinction between the Class 1 route and the Class 2-4 route is summarised in the following comparison, which reflects the Thai FDA requirements as applied to the two routes.

The Class 1 document list published on the Thai FDA website comprises: labels, IFU, product specifications, device description and characteristics, materials, the declaration of conformity, regulatory approval history where available, sterilisation reports for sterile devices only, calibration reports for devices with measuring functions only, the device listing and grouping where a grouped application is filed, and the Letter of Authorization (LoA).

The obligations that do not lighten with risk are grounded in three instruments: the MoPH labelling notification B.E. 2568 (2025), which requires Thai language for home-use Class 1 labelling and IFU; the MoPH notification on device defects, adverse events and FSCA reporting B.E. 2563 (2020), which applies to all classes including Class 1; and the Thai FDA renewal window, which runs each year from 1 October to 31 December through SKYNET and closes the import channel for any class that misses it.

3. Expert insights

Sterile devices and devices with measuring functions are called out separately in the Class 1 list for a reason: both characteristics materially raise risk. For a sterile device, failure of the sterile state creates an infection risk, which is why a sterilisation report is required; for a device with a measuring function, a measurement that drifts out of calibration leads to diagnostic or treatment errors, which is why a calibration report is required. These two are the only additional-evidence requirements inside the Class 1 simplified list, and they are also the two items most often missed. The reason they get missed is psychological rather than technical: teams that hear simplified route assume that simplified means few checks, and they discover the missing report only at review or at inspection. The professional habit is to treat the two characteristics as a screening question asked at project start, not as a line item discovered at dossier assembly. A Class 1 product that is sterile or measures something is, for documentation purposes, a Class 1 product with two extra evidence files, and planning for them from day one removes the entire category of late surprises.

4. Practical recommendations

• Build a three-item Class 1 compliance checklist: confirm whether the device is sterile or has a measuring function, which decides the additional reports; confirm whether it is for home use, which decides the Thai language requirement; and confirm the quality system conforms to the GMP standard, because no submitted certificate does not mean no inspection.
• Assemble the Class 1 document list against the Thai FDA website list: labels, IFU, product specifications, device description and characteristics, materials, declaration of conformity, regulatory approval history if any, sterilisation report for sterile devices, calibration report for devices with measuring functions, device listing and grouping where applicable, and the LoA.
• Check whether the product is Class 1 home use, and if so prepare the labelling and IFU in Thai under B.E. 2568.
• Set up the defect and adverse event reporting process under B.E. 2563 for Class 1 products exactly as for higher classes.
• Calendar the annual renewal window, 1 October to 31 December each year, through SKYNET, and treat a missed window as a closed import channel, because the consequence is the same for Class 1 as for Class 4.

5. Verification checklist

• □ Verification basis date: 26 October 2026.
• □ Thai FDA website Class 1 document list.
• □ Thai FDA GMP guidance, confirming Class 1 is exempt from certification but must comply.
• □ MoPH GMP notification B.E. 2566 (2023).
• □ MoPH labelling notification B.E. 2568 (2025), Thai language requirement for home-use devices.
• □ MoPH notification on device defect, adverse event and FSCA reporting B.E. 2563 (2020), applicable to all classes.
• □ Thai FDA renewal window, 1 October to 31 December each year.

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