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CMDN — Class A Device Notification

PH-Unique · Certificate of Medical Device Notification · Class A devices

What Is the CMDN?​

The Certificate of Medical Device Notification (CMDN) is the regulatory approval for Class A (low-risk) medical devices in the Philippines. It is a notification-based pathway — meaning the regulatory burden is lighter than the full registration pathway (CMDR) for higher-risk devices.

Despite being called a "notification," the CMDN still requires submission to CDRRHR and involves a review before the certificate is issued.

Who Uses the CMDN Pathway?​

Any manufacturer or importer of Class A medical devices (non-IVD) seeking to place devices on the Philippine market.

Note: IVDs are currently exempt from registration requirements — see What Is a Medical Device?.

CMDN Application Requirements​

1. License to Operate (LTO)​

The applicant must hold a valid LTO as a manufacturer, importer, or distributor before submitting a CMDN application.

2. Basic Product Information​

  • Device name / trade name
  • Intended use / intended purpose
  • Device description — materials, principle of operation
  • Configuration and variants covered

3. Minimal Technical Dossier​

Class A requires a lighter technical package compared to CMDR:

  • Device description and specifications
  • Labelling and IFU compliant with AO 2018-0002
  • Declaration of conformity with essential principles
  • Manufacturing information (country of origin, manufacturer details)

4. Authorization Documents​

  • Letter of Authorization (LOA) from the foreign manufacturer to the Philippines license holder
  • Notarised declaration from the manufacturer confirming device safety and performance
  • Free Sale Certificate (FSC) from the country of manufacture (issued by the competent authority)

5. Payment of Fees​

Application fees as per DOH AO 50 s.2001 fee schedule. Confirm current fees from the CDRRHR or FDA website.

CMDN Processing Timeline​

Class A CMDN applications are processed faster than CMDR applications due to the lower-risk nature of the products. Typical processing time is weeks to a few months — exact timelines depend on CDRRHR workload and application completeness.

90-calendar-day rule: If CDRRHR raises a deficiency in the application, the applicant has 90 calendar days to address it. Applications not responded to within 90 days are deemed abandoned.

CMDN Validity and Renewal​

The CMDN has a defined validity period. Renew before expiry to maintain uninterrupted market access. Submit the renewal application with updated documentation (current LTO, current FSC, current ISO 13485 certificate if applicable).

One Application Per Device​

As a general rule, each device requires its own CMDN application. However, exceptions may apply for devices meeting specific shared application conditions — confirm current grouping/shared application rules with CDRRHR.