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Medical Device Regulation in Thailand
Medical devices in Thailand are regulated under the Medical Device Act B.E. 2551 (2008), as amended. Four risk classes (1-4) determine pre-market and post-market obligations.
TL;DR
Medical devices in Thailand are regulated under the Medical Device Act B.E. 2551 (2008), substantially amended in 2019 to align with the ASEAN Medical Device Directive (AMDD). The FDA-Thai Medical Device Control Division administers. Devices are classified into four risk classes (1, 2, 3, 4). Pre-market obligations include notification (Class 1) or registration (Classes 2-4); post-market includes adverse-event reporting.
Risk Classes
| Class | Risk | Pre-market |
|---|---|---|
| 1 | Low (bandages, manual surgical) | Notification |
| 2 | Low-medium (IVD, syringes) | Registration |
| 3 | Medium-high (orthopaedic, electromedical) | Registration + QMS evidence |
| 4 | High (implants, life-supporting) | Registration + clinical data |
Registration Path
- Classify device per AMDD rules.
- Compile Common Submission Dossier Template (CSDT).
- QMS evidence (ISO 13485 commonly accepted).
- Clinical evaluation report.
- FDA-Thai review (timeline by class).
- Licence issued; renewable per term.
Post-Market Obligations
- Adverse-event reporting (15 / 30 / 90 day windows by severity).
- Field-safety corrective actions.
- Re-registration on major change.
- Annual reports for Class 3 / 4.
Common Mistakes
- Misclassifying borderline products (e.g., wellness apps that meet medical-device definition).
- Using foreign clinical data without bridging study.
- Skipping QMS evidence.
FAQs
1. Software-as-a-medical-device (SaMD)?
Yes — SaMD is regulated; classification per intended use.
Related Reading
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