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CMDR — Class B/C/D Registration

PH-Unique · Certificate of Medical Device Registration · Class B · C · D

What Is the CMDR?​

The Certificate of Medical Device Registration (CMDR) is the full registration approval for Class B, C, and D medical devices in the Philippines. It requires a comprehensive technical review and full ASEAN CSDT dossier submission.

CMDR Application Requirements​

1. License to Operate (LTO)​

Valid LTO for the applicant entity (importer, manufacturer, or distributor) is a prerequisite.

2. ASEAN CSDT — Full Format​

The CMDR application must use the ASEAN Common Submission Dossier Template (CSDT) full format. This ensures compatibility with other ASEAN market submissions.

CSDT SectionContent
AdministrativeApplicant, manufacturer, device identification, application type
Device descriptionIntended purpose, operating principle, materials, configurations
Classification justificationClass assignment and applicable ASEAN AMDD rules
Essential principles checklistMapping each requirement to compliance evidence
Design verification and validationBench tests, performance testing
Risk managementISO 14971 summary
Clinical / performance evaluationCER (general devices) or performance evaluation (IVDs when applicable)
LabellingPhilippines-compliant labelling per AO 2018-0002
QMS evidenceISO 13485 certificate
Manufacturing informationSite details, GMP evidence

3. Letter of Authorization — PH-Unique Requirements​

The Letter of Authorization (LOA) is a critical document with specific Philippines requirements:

  • Must be from the legal manufacturer
  • Must include a notarised declaration from the manufacturer confirming:
    • The device meets the essential principles of safety and performance
    • The technical data in the dossier is accurate and complete
    • The manufacturer authorises the named Philippines entity to hold the registration
  • Apostille or authentication may be required for the notarisation depending on the country of origin — confirm with CDRRHR

4. Free Sale Certificate (FSC)​

From the regulatory authority of the country of manufacture. Must be current at the time of submission.

5. QMS Evidence — ISO 13485​

ISO 13485 certificate from an internationally accredited certification body, covering the relevant product category.

6. Risk Management — ISO 14971​

Risk management summary covering hazard identification, risk controls, and benefit-risk analysis.

7. Clinical / Performance Evaluation​

  • Class B: Clinical evaluation summary or equivalent literature evidence
  • Class C: Detailed CER; may require clinical investigation data for novel devices
  • Class D: Comprehensive clinical evidence; rigorous CER

Separate Certificate Per Device​

As a general rule, a separate CMDR is required for each device. Shared or grouped applications may be possible under specific conditions — confirm current shared application conditions with the CDRRHR before attempting a grouped submission.

90-Day Compliance Period for Deficiencies — PH-Unique​

If CDRRHR identifies deficiencies in the application:

  1. CDRRHR issues a deficiency notice
  2. Applicant has 90 calendar days to submit a complete response addressing all deficiencies
  3. If the response is incomplete or not submitted within 90 days, the application is deemed abandoned
  4. An abandoned application requires a fresh re-application with fees

Strategic tip: Prepare a complete, high-quality dossier to minimise deficiencies. If deficiencies are received, respond completely — partial responses restart the deficiency clock without resolving issues.

Re-Application After Disapproval​

If a CMDR application is formally disapproved (rejected), the applicant may re-apply within 60 days of the disapproval notice. The re-application must address all grounds for disapproval. After 60 days, a fresh application with fees is required.

CMDR Validity and Renewal​

The CMDR has a defined validity period. Submit a renewal application before expiry with:

  • Current LTO
  • Updated ISO 13485 certificate
  • Updated FSC
  • Declaration of any changes during the previous validity period