Guidance & Resources

CDRRHR · ASEAN CSDT templates · DOH AO 2018-0002 · Fee schedule

Key CDRRHR / FDA Philippines Documents

Document	Content	Source
DOH AO 2018-002	Medical device registration requirements — full operational rules	FDA Philippines website
FDA Circular 2022-008	Abridged ASEAN NRA pathway — 30 working days	FDA Philippines website
DOH AO 2018-0002	Labelling requirements	FDA Philippines website
DOH AO 50 s.2001	Fee schedule for all FDA Philippines applications	FDA Philippines website
ASEAN CSDT templates	Full format CSDT for Class B/C/D (CMDR)	FDA Philippines website / ASEAN resources
Application forms	LTO, CMDN, CMDR application forms	FDA Philippines website / CDRRHR
CMDN/CMDR list	Public list of registered medical devices	FDA Philippines website

CMDN/CMDR Public List — PH-Unique

FDA Philippines publishes a public list of all registered medical devices (CMDN and CMDR holders) on the FDA website. This list can be consulted by:

• Healthcare purchasers confirming a device is validly registered
• Manufacturers checking existing registrations
• Regulatory affairs professionals confirming registration status

Access at: www.fda.gov.ph/list-of-registered-medical-devices/

ISO Standards Summary

Standard	Required For
ISO 13485:2016	Class B/C/D (CMDR) — manufacturer QMS
ISO 14971:2019	All registered devices — risk management
IEC 62304	SaMD — software lifecycle
IEC 62366-1	Usability engineering
ISO 10993 series	Biocompatibility
IEC 60601-1	Active/electrical devices

LOA Notarisation Requirements — PH-Unique

The Letter of Authorization (LOA) from foreign manufacturers must include a notarised declaration. Confirm with CDRRHR whether apostille authentication is required for the notarisation depending on the manufacturer's country. This is a frequent cause of application delays — address it early.

Official Source

All documents: FDA Philippines CDRRHR — www.fda.gov.ph/center-for-device-regulation-radiation-health-and-research/