Southeast Asia
3 articles
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.
ASEAN Medical Device Directive (AMDD) & CSDT Guide (2026): Complete Regional Registration, Harmonization Status & Member State Requirements
Everything you need to know about the ASEAN Medical Device Directive (AMDD) and Common Submission Dossier Template (CSDT) in 2026 — including harmonized classification (Class A–D), CSDT sections and preparation, member state implementation status, regulatory reliance pathways, Singapore–Malaysia pilot, fees, timelines, and step-by-step guidance for multi-country ASEAN market entry.
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.