Philippines

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.

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.