CMDN vs CMDR
Class A needs a CMDN; Class B–D listed in Circular 2021-001-A needs a CMDR before importation.
Free field guide · PDF
Philippines FDA Medical Device Registration2026 Field Guide
CMDN vs CMDR, the ASEAN abridged route, and the 2026 renewal rule — with the CPR validity reality.
- CPR validity
- 6 yrs
- ASEAN abridged
- 30 days
- Renewal window
- 120 days
Sourced from FDA Philippines 2026 circulars and advisories.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — FDA Philippines 2026 circulars and advisories.
The ASEAN abridged route
Devices approved by any ASEAN NRA get abridged processing — 30 working days from proof of payment.
The 2026 renewal rule
Advisory 2026-1007: renew within 120 days of expiry and your CPR stays valid pending the FDA's decision.
Sources & scope
- fda.gov.ph, FDA Advisory No.2026-1007 (CPR continued validity).
- fda.gov.ph, FDA Circular No.2022-008 (ASEAN abridged processing).
- asiaactual.com, Philippines CMDN to CMDR labeling guidance.
- canaveral.group, FDA revises fees, extends registration validity.
- FDA Philippines presentation, medical device control in the Philippines.
This guide is market-access intelligence, not regulatory or legal advice. FDA Philippines timelines, CMDN/CMDR rules, and renewal obligations are product-specific — professional review is required before business use.
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