Market
Philippines
3 articles
Regulatory
Philippines FDA Advisory 2026-1007: CPR Validity, 120-Day Clock & CMDN/CMDR
Operational guide to FDA Advisory 2026-1007: CPR validity during renewal, RA 9711 IRR 120 days, customs proof, CMDN/CMDR 90-day filing, and fee suspension.
30 min read2026-09-03
›Reimbursement & Market Access
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.
16 min read2026-04-10
›Regulatory
Philippines Medical Device Registration Guide: PFDA Process, Fees, and Classes
Register medical devices in the Philippines with PFDA/CDRRHR classification, CMDN and CMDR pathways, LTO requirements, ASEAN AMDD alignment, fees, and submission steps.
16 min read2026-04-04
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