Recent Regulatory Changes
CDRRHR · FDA Philippines · 2022–2026 developments
2022
FDA Circular 2022-008 — Abridged ASEAN NRA Pathway
Published in 2022, FDA Circular 2022-008 introduced the abridged CMDR pathway for devices already approved by a recognised ASEAN NRA:
- 30 working-day processing from payment receipt
- Leverages ASEAN NRA technical assessment
- Identical device specification requirement
- CDRRHR retains right to withhold approval if safety concerns exist
This circular significantly reduces the registration burden for devices with existing ASEAN approvals.
Ongoing Developments
ASEAN AMDD Harmonisation
The Philippines continues to participate in ASEAN medical device harmonisation activities:
- ASEAN CSDT updates are incorporated as they are agreed at the ASEAN level
- Philippines participates in ASEAN regulatory convergence working groups
- Further expansion of reliance frameworks is under ongoing discussion
CDRRHR Enforcement Activity
CDRRHR and the Bureau of Customs have increased coordination on interception of unregistered medical devices at ports of entry. Compliance with CMDN/CMDR registration requirements before shipment is essential.
Reform Tracker
| Expected Development | Status | Action |
|---|---|---|
| IVD registration requirements | Announced — implementation date TBD | Monitor CDRRHR website — see IVD Update page |
| eReport system enhancements | Ongoing | Use current system; check for updates |
| ASEAN CSDT format updates | Periodic | Download fresh CSDT template for each new application |
| Fee schedule revision (DOH AO 50) | Periodic | Confirm current fees before each application |
Monitoring CDRRHR Updates
Stay current with Philippines regulatory developments:
- FDA Philippines website: www.fda.gov.ph
- CDRRHR: www.fda.gov.ph/center-for-device-regulation-radiation-health-and-research/
- FDA Philippines administrative orders — published on FDA website and Official Gazette
- FDA Circulars — published on FDA website; new circulars may change requirements with limited notice