The SKYNET renewal
Class 4 and Class 2–3 products carry an annual SKYNET renewal — Oct 1 to Dec 31, grace to Jan 31.
Free field guide · PDF
Thailand FDA Medical Device Registration2026 Field Guide
The SKYNET renewal, establishment licensing, and the class-based fee map — with the 2026 regulatory changes.
- SKYNET renewal
- Oct–Dec
- Class 4 fee
- THB 74K
- Class 4 TAT
- 300 days
Sourced from Thai FDA 2026 registration guidance and 2026 legal updates.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — Thai FDA 2026 registration guidance and 2026 legal updates.
Establishment first
The licensed Thai importer comes first — establishment licensing runs on fixed 10–30 working-day clocks.
The class fee map
Class 1 THB 3,100 / up to 80 days, Class 2–3 THB 49,000 / 250 days, Class 4 THB 74,000 / 300 days.
Sources & scope
- brerrabbitlegal.co.th, Thai FDA medical device license renewal 2026: the SKYNET deadline.
- artixio.com, medical device regulations & registration process in Thailand.
- lexbangkok.com, Thailand medical device registration: with or without 510(k).
- arqon.com, Thailand FDA registration.
This guide is market-access intelligence, not regulatory or legal advice. Thai FDA timelines, fees, and renewal obligations are product-specific — professional review is required before business use.
Market Access Strategy Session
Thailand on your roadmap? Start with the full picture.
A Market Access Strategy Session maps your Thai FDA route — importer selection, SKYNET renewal planning, and the class-based filing plan.
Professional review is required before business use.
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