Educational Information Only
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MDA Section 5 — Device classification
Medical Device Act (พระราชบัญญัติเครื่องมือแพทย์) — Section 5.
Plain-English Summary
Four-class risk-based system (Class 1 low risk → Class 4 highest risk).
Official Text
Official Thai text at the Royal Gazette / Office of the Council of State. Translation summary only.
Consult official sourceParent Statute
Medical Device Act
พระราชบัญญัติเครื่องมือแพทย์ · B.E. 2551 (2008)
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).
The summary above is a plain-English educational paraphrase of Section 5 of the Medical Device Act. It is not an authoritative translation. For the binding Thai text, consult the Royal Gazette or the Office of the Council of State. Educational use only — not a substitute for advice from a Thai-qualified lawyer.
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