Thailand
5 articles
Thailand Medical Device Registration Cost 2026: Thai License Holder Pricing Models, Flat Fee vs Hourly Billing, and 3-Year Cash Flow Comparison
How much does it cost to register a medical device in Thailand in 2026? A buyer-side breakdown of Thai License Holder service pricing — hourly billing, registration-fee-plus-annual, and flat all-inclusive fee — with worked 3-year cash flow scenarios for Class 1/2 listings/notifications and Class 3/4 notifications/licenses.
ASEAN Medical Device Entry: The 6-Country Matrix for Distributor Qualifications and FDA/NMPA Test Report Reuse
A reference matrix answering two questions not covered in any existing ASEAN guide: what specific licenses, QMS certifications, warehouse infrastructure, and pharmacovigilance setup must your distributor hold in each of the 6 major ASEAN markets, and which countries accept FDA or NMPA test reports without full retest.
Thailand Medical Device Procurement: NHSO Universal Coverage, E-Bidding & Market Access Guide (2026)
How Thailand's government procures medical devices through the National Health Security Office (NHSO), e-Market and e-Bidding electronic procurement, the Universal Coverage Scheme, Thai FDA regulatory requirements, Innovation List procurement preferences, and practical strategies for foreign manufacturers entering Thailand's $2.2 billion medical device market.
Thailand Medical Device Registration Guide (2026): Complete Thai FDA Process, Fees, Classification & Requirements
Everything you need to know about registering medical devices in Thailand in 2026 — including Thai FDA classification (Class 1–4), CSDT requirements, establishment licensing, e-Submission system, fees in THB, auto-approval for Class 1, Medical Device Act B.E. 2551, local importer obligations, and step-by-step registration instructions.
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.