Thailand Medical Device Classification: Classes 1 to 4 Explained

1. Key takeaways

Thailand divides medical devices into four risk classes: Class 1 (low risk), Class 2 (low to medium risk), Class 3 (medium to high risk) and Class 4 (high risk). The legal basis is the Ministry of Public Health Notification on the Risk Classification of Medical Devices, B.E. 2562 (2019), published in the Government Gazette on 18 December 2019, with rules aligned to the ASEAN Medical Device Directive. The classification drives four downstream variables at once, the certificate type, the dossier depth, the review timeline and the fee tier, so no other single determination in the Thai system carries as much weight as this one. Before any dossier work begins, the class must be fixed, because every document, fee and deadline in the programme is derived from it.

The mapping between classes and certificates deserves emphasis because it surprises newcomers. Class 1, the low-risk tier, is controlled through listing. Class 2 and Class 3, which sit at the low-to-medium and medium-to-high risk levels, are both controlled through notification, meaning they share one certificate type. Class 4, the high-risk tier, is controlled through licensing. This structure is unusual among major jurisdictions and explains why Thailand issues three certificate types for four risk classes.

• Four classes apply, but the historical three-tier naming of general devices, controlled devices and specially controlled devices belongs to the old framework and must not be used as the current standard or mixed with the new one.
• Four classes map onto three certificates: Class 1 receives a Certificate of Listed Medical Device, Class 2 and Class 3 share a Certificate of Notified Medical Device, and Class 4 receives a Certificate of Licensed Medical Device.
• Class 3 is therefore not the top tier in Thailand; Class 4 is. The American intuition that Class III means the highest level must not be applied here.
• For non-IVD devices, classification considers intended purpose and manufacturer claims, duration of contact with the human body, degree of invasiveness, whether the device is active and powered, and the software risk level for SaMD.
• IVDs follow a separate risk ladder that additionally weighs the public health consequences of a wrong result, which is why HIV, HBV and HCV assays sit high on it.
• Classification disputes are decided by the Secretary-General of the Thai FDA under Article 4 of the classification notification, so classification is reviewable, not self-declared.

2. Legal basis

The governing instrument is the MoPH Notification on the Risk Classification of Medical Devices B.E. 2562 (2019), gazetted on 18 December 2019, whose rules are aligned with the AMDD. Article 4 of that notification provides that classification disputes are ruled on by the Secretary-General of the Thai FDA, which means classification is not simply chosen by the applicant: it can be re-checked and adjudicated, the classification basis must be submitted with the application, and the review stage will verify it. A wrong classification carries four concrete consequences. It determines the certificate type. It determines the dossier depth, since Class 2 to 4 require CSDT documentation and ISO 13485. It determines the review time limits, with statutory caps of 200, 250 and 300 days across the higher classes. And it determines the fee tier, with import filings priced at approximately 3,100 baht for Class 1, approximately 49,000 baht for Class 2 to 3 and approximately 74,000 baht for Class 4. A misclassification leads at best to a deficiency return and at worst to a finding of a false declaration.

3. Expert insights

The recurring failure mode in Thai classification work is optimism at the boundary. When a product sits between two classes, some applicants file at the lower class and hope the reviewer agrees. If the reviewer upgrades the classification, the entire dossier must be rebuilt to the higher standard and the review clock restarts, so the real loss far exceeds the incremental cost of preparing the evidence to the higher class at the outset. A practical estimate for any borderline product is therefore to prepare evidence to the higher class first and treat the lower filing as the exception to justify, not the default. For genuinely uncertain cases, the disciplined route is to obtain a formal classification confirmation from the Thai FDA before investing in dossier preparation, so that the certificate type, dossier depth, review timeline and fee tier are all locked before money is spent.

4. Practical recommendations

• Determine the Thai class under the B.E. 2562 notification for every product, and never import an EU or US class designation into Thai documents.
• Purge the old three-tier terminology, general, controlled and specially controlled, from all live documents and external communications, keeping the Class 1 to 4 system as the only current standard.
• When presenting the mapping to stakeholders, state it as Class 1 to Listed, Class 2 and 3 to Notified, Class 4 to Licensed, and explicitly warn against the Class III equals highest assumption.
• Document the classification basis, covering intended use, contact duration, invasiveness, energy and software risk, so the review re-check finds a coherent justification.
• For borderline products, submit a formal classification confirmation request to the Thai FDA before dossier preparation, and budget evidence to the higher class in the meantime.

5. Verification checklist

• □ MoPH Notification on the Risk Classification of Medical Devices B.E. 2562 (2019), Government Gazette 18 December 2019, Articles 2, 3, 4 and 5, with Article 4 assigning dispute rulings to the Secretary-General (pending verification).
• □ Medical Device Act (No. 2) B.E. 2562 (2019) confirmed (pending verification).
• □ ASEAN Medical Device Directive classification principles confirmed (pending verification).
• □ Thai FDA website classification lookup tool and For Commercial Purpose Step 4 confirmed (pending verification).
• □ Thai FDA official fee table for Class 1, Class 2 to 3 and Class 4 import filings (pending verification).

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