Market
Philippines
2 articles
Reimbursement & Market Access
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.
16 min read2026-04-10
›Regulatory
Philippines Medical Device Registration Guide (2026): Complete PFDA Process, Fees, Classification & Requirements
Everything you need to know about registering medical devices in the Philippines in 2026 — including PFDA/CDRRHR classification (Class A–D), CMDN vs CMDR pathways, ASEAN AMDD alignment, LTO requirements, English-language submissions, fees in PHP, and step-by-step registration instructions.
15 min read2026-04-04
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