Class 2 and Class 3 Notification Pathway in Thailand: Dossier and Fees

Do Class 2 and Class 3 devices follow the same route in Thailand? The answer is yes. Both classes go through the Notification pathway and receive the Certificate of Notified Medical Device. This is the single most counter-intuitive feature of the Thai system when compared with the instinct created by risk classification: there are four risk classes, but only three types of certificate, and Class 2 and Class 3 share the same one.

1. Key takeaways

Sharing a certificate type does not mean sharing a workload. The practical reality for Class 2 and Class 3 applicants in Thailand can be summarised in the points below.

• Class 2 and Class 3 both use the Notification pathway and both receive the Certificate of Notified Medical Device. Classification has four tiers, but certificates come in only three kinds.
• The dossier depth and review intensity differ between the two classes: the Class 3 document burden is heavier, and the probability of triggering expert review is higher. For Class 2 expert review is rare; for Class 3 it happens sometimes.
• Both classes submit under the shared Class 2-4 document matrix (Full route), which runs from labels and IFU through the executive summary, device description, Essential Principles, verification and validation summary, risk analysis, manufacturer information, ISO 13485 quality system certificate, declaration of conformity and letter of authorisation.
• Expert review is a case-by-case surcharge decided by the Thai FDA when it considers deeper technical assessment necessary, typically because a technology is new or immature. The pattern is: Class 1 never, Class 2 rarely, Class 3 sometimes, Class 4 often.
• Official fees for Class 2-3 on the import route are: application fee 1,000 + expert fee 38,000 + certificate fee 10,000 = 49,000 Thai baht in total. For local manufacturing: 1,000 + 30,400 + 5,000 = 36,400 Thai baht. Where expert review is not triggered, the import base tier is 1,000 + 10,000 = 11,000 Thai baht.
• ISO 13485 is mandatory for Classes 2-4. The certificate must cover the legal manufacturer and the actual manufacturing site, and must be within its validity period. Class 1 is exempt from this requirement.

2. Legal basis

The submission requirements derive from the Class 2-4 document matrix published on the Thai FDA website (Full route), and the classification obligations rest on the MoPH classification notification B.E. 2562 (2019). The fee levels are set by the ministerial regulation on medical device fees B.E. 2563 (2020) and the MoPH fee announcement B.E. 2564 (2021), as reflected in the fee schedule published on the Thai FDA website. The expert review mechanism is decided by the Thai FDA case by case. The core items of the shared Full-route matrix are set out below.

3. Expert insights

The expert review mechanism deserves careful attention, because it is the main source of fee uncertainty on this pathway. The Thai FDA adds an expert review fee case by case when it judges that a device needs deeper technical evaluation, most often because the technology is comparatively new or not yet mature. The observed pattern across classes is stable: Class 1 never triggers expert review, Class 2 rarely does, Class 3 sometimes does, and Class 4 does frequently. This means Class 2-3 official fees effectively exist in two tiers: a lower tier when expert review is not triggered, and a higher tier payable when it is, calculated as the total including the expert fee of 38,000 baht on the import route.

A second insight concerns the ISO 13485 obligation. It is not enough for the certificate to exist somewhere in the corporate structure: it must cover the legal manufacturer and the actual production site, and it must be valid. Teams discover late that a certificate issued to a different entity or an expired certificate fails the check, and correcting this involves the certification body, not the regulator, which is slower than any submission step.

4. Practical recommendations

• When budgeting a Class 2 or Class 3 project, plan first on the tier that includes expert review (49,000 baht on the import route), then settle accounts according to whether it is actually triggered. Expert review is decided case by case and cannot be ruled out in advance; budgeting high and settling by reality is far safer than budgeting low and being billed for the difference later.
• Verify early that the ISO 13485 certificate covers the legal manufacturer and the actual manufacturing site, and confirm its expiry date extends across the expected review period.
• Prepare the dossier to the Full-route matrix even if expert review never arrives, since the same base set serves any Class 2-4 submission and any later pathway change.
• Assess the novelty of the technology honestly: devices based on newer or less mature technologies should expect the higher tier and schedule accordingly.
• Keep the declaration of conformity, letter of authorisation and manufacturer information aligned across documents, since inconsistencies here generate avoidable deficiency rounds.
• Use e-Submission for filing, and keep every document in the matrix consistent with the declaration of conformity and the letter of authorisation to avoid avoidable deficiency exchanges.
• Where expert review is not triggered, the import base tier of 11,000 baht applies; where it is triggered, the total including the expert fee becomes payable.

5. Verification checklist

• □ Thai FDA website Class 2-4 document checklist matrix (Full / Abridged / Reliance with HSA)
• □ Thai FDA website fee schedule (Class 2-3 import 49,000 baht / local 36,400 baht; expert fee 38,000 baht)
• □ MoPH classification notification B.E. 2562 (2019)
• □ Thai FDA case-by-case expert review decision mechanism
• □ Ministerial regulation on medical device fees B.E. 2563 (2020) and MoPH fee announcement B.E. 2564 (2021)

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