Educational Information Only
The content on this page is for general educational purposes and does not constitute legal advice. Every legal situation is unique. For matters involving investigation, arrest, litigation, or formal proceedings, consult a qualified legal professional.
Medical Device Act
พระราชบัญญัติเครื่องมือแพทย์ · MDA · B.E. 2551 (2008)
Overview
The Medical Device Act B.E. 2551 (2008) regulates medical device registration, manufacture, import, sale, and post-market surveillance. The Thai FDA administers, with risk-based classification aligned to ASEAN Medical Device Directive (AMDD).
- Promulgating authority
- Parliament
- พระราชบัญญัติ
- Enacted
- B.E. 2551 (2008)
- Official text
- https://www.ocs.go.th/searchlaw
Key Sections2
The 2 sections most frequently cited in practice or relevant to foreigners. Click any section for a deep-linkable page suitable for sharing.
Section 6
— Device control categoriesSection 6(1) sorts medical devices by control level — those needing a licence, a detail-notification, or a registration-notification (จดแจ้ง) — broadly tracking the ASEAN risk classes. (Section 5 only names the Minister in charge.)
Section 15
— Registration / licence requirementMaking or importing devices requires FDA authorisation: establishment registration (Section 15), a product licence for the highest-control group (Section 17), or a detail-/registration-notification for lower groups (Section 19). (Section 14 only makes committee members officials under the Penal Code.)
The summaries on this page are plain-English educational paraphrases — not authoritative translations. For the binding wording you must consult the Royal Gazette publication or the consolidated text at the Office of the Council of State. Educational use only — not a substitute for advice from a Thai-qualified lawyer.
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