Skip to main content

FDA eServices Portal

PH-Unique · FDA Circular 2025-007 · Online submission · CMDN / CMDR

Overview​

The FDA Philippines eServices Portal is the online platform for submitting medical device applications to CDRRHR. FDA Circular 2025-007 (issued 2025) mandates use of the eServices Portal for initial CMDN applications.

What Can Be Submitted Through eServices​

Application TypePortal Available
CMDN (Class A) — Initial applicationYes — mandated via FDA Circular 2025-007
CMDR (Class B/C/D) — Initial applicationYes (online submission)
CMDN / CMDR RenewalYes
Variation / amendment applicationsYes
LTO applicationsYes (separate LTO module)
Adverse event reports (eReport)Yes — eReport module within the portal

Account Setup​

Before submitting any application, establish an eServices account:

  1. Navigate to the FDA Philippines eServices Portal (fda.gov.ph)
  2. Register an account for your establishment — one account per LTO holder
  3. Complete the establishment profile — company name, LTO number, contact details
  4. Await account verification by CDRRHR

Tip: Complete account registration well before your intended submission date — verification can take time, particularly during high-volume periods.

Submitting a CMDN Application — Key Steps​

  1. Log into the eServices Portal
  2. Select "Medical Devices" → "New Application" → "CMDN"
  3. Complete the online application form — device name, class, manufacturer details
  4. Upload required documents (PDF format):
    • Device description / Declaration of Safety and Performance
    • Classification justification
    • Philippines-compliant label
    • Letter of Authorization (LOA)
    • Free Sale Certificate (FSC)
  5. Pay application fees electronically
  6. Submit — receive a transaction reference number
  7. Track application status through the portal

Submitting a CMDR Application​

CMDR applications follow the same portal workflow but require upload of the full ASEAN CSDT documents:

Upload each CSDT section as separate PDF files. Ensure file sizes are within portal limits — compress large test reports if necessary without compromising legibility.

Application Tracking​

Track application status in the portal dashboard:

  • Pending — submitted, awaiting CDRRHR review
  • Under Evaluation — actively under review
  • Deficiency Notice — deficiencies identified; respond within 90 calendar days
  • Approved — certificate ready for download / collection
  • Disapproved — with reasons stated; right to re-apply within 60 days

Responding to Deficiency Notices​

When a deficiency notice is issued:

  1. Log into the portal and access the deficiency notice in the application record
  2. Review all deficiency items carefully
  3. Prepare a complete response addressing every deficiency point
  4. Upload response documents through the portal within 90 calendar days
  5. If additional time is needed, contact CDRRHR — partial responses or late responses may result in application abandonment

Certificate Download​

Approved CMDN and CMDR certificates are available for download through the eServices Portal. Maintain electronic copies for LTO inspections and distributor records.

eReport — Adverse Event Reporting Module​

Adverse event reports are submitted through the eReport module within the eServices Portal. See Vigilance & Adverse Event Reporting for reporting obligations and timeframes.

Fees​

Application fees are paid electronically through the portal. Current fee schedules are set by DOH Administrative Order and are updated periodically. See Guidance & Resources for the current fee reference.