CMDN / CMDR Maintenance
PH-Unique · Certificate renewal · Variation · Transfer · Cancellation
Certificate Renewal
CMDN and CMDR certificates have defined validity periods. Renewal must be completed before expiry.
Renewal Application Contents
- Current, valid LTO
- Updated ISO 13485 certificate (Class B/C/D)
- Updated FSC from country of manufacture
- Declaration of any changes during the previous validity period
- Payment of renewal fees (per DOH AO 50 s.2001)
Submit renewal applications well before expiry — allow at least 3–6 months for processing, accounting for any deficiency response time under the 90-day rule.
Product Variation and Amendments
Significant changes to a registered device require a variation application to CDRRHR:
| Change Type | Variation Required |
|---|---|
| Device name or trade name | ✅ Yes |
| Intended purpose or indication | ✅ Yes |
| Device design, materials, or specifications | ✅ Yes |
| Manufacturing site change | ✅ Yes |
| Labelling change (significant) | ✅ Yes |
| License holder change | ✅ Yes (transfer application) |
Minor administrative changes may be handled via a simple notification — confirm with CDRRHR.
Transfer of Registration — Changing the License Holder
If the Philippines license holder changes:
- Submit a transfer of registration application to CDRRHR
- Both outgoing and incoming entities must cooperate
- Incoming entity must hold a valid LTO
- Incoming entity assumes all post-market obligations from transfer date
- Plan transfer to avoid gaps in valid CMDN/CMDR coverage
Grounds for CMDN/CMDR Cancellation
CDRRHR may cancel a CMDN or CMDR for:
- Safety concerns arising from post-market data
- Persistent non-compliance with registration conditions
- Failure to renew
- Provision of false or misleading information in the application
- Falsification or alteration of the certificate — triggers criminal prosecution
- Failure to comply with CDRRHR recall orders
Voluntary cancellation: The license holder may request voluntary cancellation if withdrawing the device from the market. Ensure all FSCA obligations are completed before requesting cancellation.