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.
In the 'Renewal Application Contents' section, change 'Updated FSC from country of manufacture' to 'Updated FSC (Free Sales Certificate) from country of manufacture — documentation proving the device is legally marketed in its country of origin'