Thailand
8 articles
Thailand FDA Medical Device Database Analysis: 43,337 Records
A comprehensive analysis of 43,337 medical device records in the Thailand FDA database, exploring active vs expired licenses, imported share, and top manufacturers.
Adverse-Event Reporting Compared: FDA 21 CFR 803, EU MDR, Brazil, Thailand & SA
Side-by-side legal-text comparison of device adverse-event reporting: FDA 21 CFR 803, EU MDR Art. 87, Brazil RDC 67/2009, Thailand MoPH, SAHPRA — triggers, timelines, who must report.
Recall vs FSCA Compared: FDA 21 CFR 806, EU MDR, Brazil & Thailand
Side-by-side legal-text comparison of medical device field actions: FDA 21 CFR Part 806, EU MDR FSCA/FSN, Brazil RDC 551/2021, and Thailand recall guidance — triggers, timelines, filing objects.
Thailand Medical Device Registration Cost 2026: License Holder Pricing
Thailand medical device registration cost guide for 2026, comparing Thai License Holder pricing, flat-fee options, and 3-year cash flow by device class.
ASEAN Device Entry: Distributor Qualification and Test Report Reuse Matrix
Six-country ASEAN matrix covering distributor licenses, QMS and warehouse requirements, vigilance setup, and where FDA or NMPA test reports may reduce retesting.
Thailand Medical Device Procurement 2026: NHSO, E-Bidding and Market Access
Guide to Thailand medical device procurement via NHSO, Universal Coverage, e-Market, e-Bidding, Thai FDA rules, Innovation List preferences, and market access.
Thailand Medical Device Registration Guide 2026: Thai FDA Process and Fees
Guide to Thailand medical device registration, Thai FDA Class 1-4 rules, CSDT, licensing, e-Submission, THB fees, auto-approval, and importer duties.
Medical Device Registration in Southeast Asia: ASEAN Harmonization & Country Guide
Navigate medical device registration across ASEAN — the AMDD framework, country-by-country requirements for Indonesia, Thailand, Malaysia, Philippines, Vietnam, and Singapore.