Philippines Class A Medical Device CMDN Notification: FDA eServices Portal Guide

Quick answer

Do Class A medical devices need CMDN in the Philippines?

Yes. Under Department of Health Administrative Order (AO) No. 2018-0002 and FDA circulars, a Certificate of Medical Device Notification (CMDN) is the market authorization for Class A (lowest-risk) medical devices regulated by the Food and Drug Administration (FDA) Philippines, Center for Device Regulation, Radiation Health, and Research (CDRRHR). Class B, C, and D devices require a Certificate of Medical Device Registration (CMDR) instead. Since 10 March 2025, all initial CMDN applications for Class A devices must be filed online through the FDA eServices Portal System at eservices.fda.gov.ph—account creation is no longer required. The legacy ePortal System for initial CMDN was deactivated on that date. Renewal and variation CMDN applications are not accepted through eServices; they must be emailed to fdac.letters@fda.gov.ph under FC No. 2020-026. Approved CMDNs use the number format CDRRHR-CMDN-YYYY-XXXXXX and appear on the public verification list at verification.fda.gov.ph. Licensed medical device establishments (manufacturers, importers, distributors) must hold the appropriate establishment licence before applying.

Who this applies to

This guide applies to:

• Philippine and foreign manufacturers placing Class A medical devices on the Philippine market
• Importers and distributors of Class A non-IVD and Class A IVD devices under the AO 2018-0002 risk framework
• Regulatory affairs teams mapping ASEAN AMDD Class A products to the Philippines notification route
• Quality and compliance staff preparing CMDN dossiers before FDA CDRRHR review
• Local authorized representatives filing on behalf of overseas manufacturers through licensed establishments

The Philippines regulates medical devices in four risk classes (A, B, C, D) aligned with ASEAN Medical Device Directive (AMDD) harmonized technical requirements under AO 2018-0002. This article covers the CMDN (Class A notification) pathway only. Devices classified as Class B, C, or D follow the CMDR registration route and are outside the scope of eServices CMDN filing.

CMDN vs CMDR: authorization types by risk class

FDA CDRRHR assigns a certificate type based on AMDD risk class. Choosing the wrong route causes rejection, re-filing fees, and market-access delays.

Key distinctions for regulatory planners:

• CMDN (Class A): Notification authorization with a streamlined dossier relative to CMDR; initial applications transact exclusively through eServices after full implementation
• CMDR (Classes B/C/D): Full registration with deeper technical review, expert evaluation where applicable, and email-based submission to CDRRHR product registration
• Renewal/variation: CMDN renewal and variation remain email-based (fdac.letters@fda.gov.ph)—FC 2025-007 explicitly excludes these from eServices scope
• Regulatory flexibility: Initial CMDN applications for Class B/C/D devices not on the registrable list under FC 2020-001-A are no longer accepted; the flexibility extension ended 30 September 2024 (FC 2024-003). Those devices now require CMDR

Legal and regulatory framework

Philippine Class A CMDN market access rests on a layered framework:

Risk classification follows ASEAN AMDD rules referenced in AO 2018-0002. Confirm your device is Class A before assembling a CMDN dossier. Products on the FC 2021-017 Annex A reference list are explicitly within Class A scope; devices reclassified to Class B or higher must follow the CMDR route instead.

Establishment licence prerequisites

Before any CMDN application, the applicant establishment must hold a valid FDA medical device establishment licence appropriate to its role:

FDA requires that manufacturers, traders, exporters, importers, and distributors hold the correct licence before product authorization. Foreign manufacturers typically route CMDN applications through a Philippine licensed establishment (local subsidiary, importer, or distributor) with a Letter of Authorization linking the overseas manufacturer to the Philippine applicant.

Without an active establishment licence, CDRRHR will not process the CMDN application regardless of dossier completeness.

eServices transition: pilot to full implementation

FDA phased CMDN eServices deployment before mandating it nationwide:

Critical transition rules from FA 2025-0189 and FC 2025-007:

• ePortal deactivated for initial CMDN from 10 March 2025 onward
• No account or password required to access eServices (FA 2025-0189, FC 2025-007 Section V.D)
• Existing ePortal applications submitted before deactivation continue processing in ePortal — re-filing in eServices is not required
• If an applicant voluntarily re-applies in eServices for the same device, a separate fee applies; prior ePortal payments are not credited
• Pilot eServices applications for Class B/C/D devices continue processing under existing pilot rules
• Fees follow the current FDA issuance on fees and charges

Step-by-step: initial CMDN via eServices Portal

Follow FC 2025-007 Annex A (filing) and Annex B (status checking), as referenced in FA 2025-0189:

Step 1: Confirm Class A classification and product scope

1. Apply AMDD classification rules under AO 2018-0002
2. Cross-check against FC 2021-017 Annex A reference list where applicable
3. Confirm the device is not subject to CMDR (Classes B/C/D) or IVD-specific rules requiring a different pathway
4. Determine grouping strategy if multiple variants share one CMDN application

Step 2: Verify establishment licence status

1. Confirm the applicant holds an active manufacturer, importer, or distributor establishment licence
2. Ensure licence scope covers the device category and intended activity (manufacture, import, or distribution)
3. Prepare Letter of Authorization if the applicant acts for a foreign manufacturer

Step 3: Access the eServices Portal

1. Navigate to https://eservices.fda.gov.ph/
2. No account registration or password is required (per FC 2025-007 and FA 2025-0189)
3. Select the CMDN initial application service for Class A medical devices

Step 4: Complete the online application form

1. Enter establishment details matching the active establishment licence
2. Provide device identification: trade name, model, intended purpose, classification rationale
3. Enter grouping information if applying for multiple variants under one CMDN
4. Specify the establishment role (manufacturer, importer, or distributor)

Step 5: Upload required dossier documents

Document requirements follow AO 2018-0002 and FC 2020-001. Typical CMDN dossier elements include:

Ensure labels, IFU, and grouping lists use consistent trade names and model numbers — mismatches are a common cause of query loops.

Step 6: Pay FDA fees and submit

1. Pay the applicable fee per the current FDA fees and charges issuance
2. Retain proof of payment — required for any re-application under FA 2024-0009
3. Submit the application through eServices
4. Note the application reference number for status tracking

Step 7: Monitor application status

1. Follow FC 2025-007 Annex B procedures to check application status in eServices
2. Respond promptly to any CDRRHR deficiency notices or verification queries
3. Contact the CMDN helpdesk at helpdesk.cmdn@fda.gov.ph or call (02) 8807-2843 / 8807-8517 for clarifications

Step 8: Download approved CMDN

1. Once approved, download the CMDN certificate from eServices per FC 2025-007 Annex B
2. Verify the CMDN number follows format CDRRHR-CMDN-YYYY-XXXXXX
3. Confirm certificate details match approved models, trade names, and establishment information
4. Cross-check listing on verification.fda.gov.ph public CMDN database

Only after CMDN issuance may the device be commercially manufactured, imported, distributed, and sold in the Philippines.

CMDN renewal and variation: email route (not eServices)

FC 2025-007 explicitly excludes renewal and variation CMDN applications from eServices scope. These continue under prior procedures:

FDA has indicated a separate procedural guideline will be issued for CMDN renewal and variation updates (FC 2025-007 Section V.G). Until then, follow FC 2020-026 and FA 2024-0009.

Re-application rules (FA 2024-0009)

When an initial or renewal CMDN application is disapproved or expires without approval:

Re-applications require a new Document Tracking Number (DTN). Initial CMDN re-applications after 10 March 2025 should be filed through eServices with proof of the latest payment.

CMDN number format and public verification

Approved CMDNs receive a standardized number:

Format: CDRRHR-CMDN-YYYY-XXXXXX

• CDRRHR — Center for Device Regulation, Radiation Health, and Research
• CMDN — Certificate of Medical Device Notification
• YYYY — year of issuance
• XXXXXX — sequential identifier

Verify CMDN validity through the public database:

• URL: https://verification.fda.gov.ph/Medical_Device_CMDNlist.php
• Search by CMDN number, product name, or establishment
• Use before import clearance, tender submissions, or distributor due diligence

Checklist

• Device confirmed as Class A under AO 2018-0002 / AMDD rules
• Product scope checked against FC 2021-017 Annex A reference list where applicable
• Establishment licence (manufacturer, importer, or distributor) active before CMDN filing
• Grouping strategy defined (single device vs grouped application)
• Label and IFU prepared for Philippine market
• Classification justification and declaration of conformity documented
• Letter of Authorization executed (foreign manufacturer → Philippine establishment)
• Grouping document prepared (if grouped application)
• Initial CMDN filed via eservices.fda.gov.ph (not ePortal) from 10 Mar 2025
• FDA fees paid per current fee schedule; proof of payment retained
• Application status monitored per FC 2025-007 Annex B
• Approved CMDN downloaded and verified on verification.fda.gov.ph
• Renewal/variation planned via email to fdac.letters@fda.gov.ph — not eServices
• Re-application timelines understood (60 days initial / 30 days renewal per FA 2024-0009)

Common pitfalls

1. Filing initial CMDN via ePortal after 10 March 2025 — ePortal is deactivated for initial CMDN; applications must use eServices
2. Submitting renewal through eServices — FC 2025-007 excludes renewal/variation; email fdac.letters@fda.gov.ph instead
3. Skipping establishment licence — CMDN applications are not processed without an active establishment licence
4. Misclassifying as Class A — Class B/C/D devices require CMDR via cdrrhr-productregistration@fda.gov.ph; misclassification triggers rejection
5. Assuming ePortal payment transfers to eServices — voluntary re-filing in eServices requires a new fee; prior ePortal payments are not credited
6. Label–IFU–grouping mismatch — inconsistent trade names or model numbers across dossier documents cause verification delays
7. Missing re-application deadline — FA 2024-0009 allows 60 days (initial) or 30 days (renewal) with PhP 1,010 fee and new DTN
8. Marketing before CMDN issuance — commercial manufacture, import, or sale requires an approved CMDN certificate

FAQ

Do Class A medical devices need CMDN in the Philippines?

Yes. Class A devices require a Certificate of Medical Device Notification (CMDN) under AO 2018-0002. CMDN is the market authorization for the lowest-risk class. Class B, C, and D devices require CMDR (registration) instead. Without an approved CMDN, the device cannot be legally placed on the Philippine market.

How do I apply for CMDN online?

Since 10 March 2025, file initial Class A CMDN applications through the FDA eServices Portal at eservices.fda.gov.ph. No account or password is required. Complete the online form, upload dossier documents per AO 2018-0002 and FC 2020-001, pay FDA fees, and submit. Follow FC 2025-007 Annex A for filing and Annex B for status checking and certificate download.

What is the difference between CMDN and CMDR?

CMDN is a notification certificate for Class A (lowest-risk) devices with a streamlined dossier. CMDR is a registration certificate for Classes B, C, and D with deeper technical review. Initial CMDN uses eServices; initial CMDR is submitted by email to cdrrhr-productregistration@fda.gov.ph. Both require an establishment licence and AMDD-based classification.

When did FDA eServices become mandatory for CMDN?

Full implementation took effect on 10 March 2025 under FA 2025-0189, following a pilot phase (FA 2024-1089). From that date, all licensed establishments must submit initial Class A CMDN through eServices. The legacy ePortal System was deactivated for initial CMDN applications on the same date.

How do I renew CMDN?

CMDN renewal and variation are not processed through eServices (FC 2025-007). Submit renewal applications by email to fdac.letters@fda.gov.ph (Food and Drug Action Center) following FC 2020-026 Item 4.2.4.2. If a renewal is disapproved or expires, re-apply within 30 days with a PhP 1,010 fee and new DTN per FA 2024-0009.

What is the CMDN number format?

Approved CMDNs follow the format CDRRHR-CMDN-YYYY-XXXXXX, where YYYY is the issuance year and XXXXXX is a sequential number assigned by CDRRHR. Verify valid CMDNs on the public list at verification.fda.gov.ph/Medical_Device_CMDNlist.php.

Can I check CMDN status on the FDA verification site?

Yes. FDA maintains a public CMDN verification list at https://verification.fda.gov.ph/Medical_Device_CMDNlist.php. Search by CMDN number, product name, or establishment to confirm authorization status before import, distribution, or procurement.

Do I need an establishment licence before CMDN?

Yes. Manufacturers, importers, and distributors must hold the appropriate FDA medical device establishment licence before filing CMDN. FA 2025-0189 requires that all licensed medical device establishments submit initial Class A CMDN through eServices from 10 March 2025.

Official sources

• FDA Philippines — FC 2025-007: CMDN initial application via eServices Portal
• FDA Philippines — FA 2025-0189: Full implementation of eServices for Class A CMDN (10 March 2025)
• FDA Philippines — FC 2021-017: Reference list of Class A medical devices
• FDA Philippines — FA 2024-0009: CMDN/CMDR initial and renewal process revision
• FDA Philippines — FDA eServices Portal
• FDA Philippines — Public CMDN verification list

Note: Some fda.gov.ph pages may return HTTP 403 to automated fetchers; these remain official FDA Philippines sources.