Philippines IVD Device Registration: Transitioning to AMDD Classification and CIVDR/CIVDN

IVD Device Registration in The Philippines (CDRRHR)

IVD device registration in the Philippines is managed by the Center for Device Regulation, Radiological Health and Research (CDRRHR) of the Food and Drug Administration (FDA). The system is currently in transition, adopting the risk classification system aligned with the ASEAN Medical Devices Directive (AMDD).

Classification and Registration Certificates

The new regulations will classify IVDs according to the AMDD risk classes (A, B, C, and D). The required certificate depends on the risk level:

• Certificate of IVD Notification (CIVDN): For lower-risk devices.
  • Validity: Class A CIVDN is valid for 5 years. Initial Class B, C, and D CIVDNs (during transition) are valid for 2 years.
• Certificate of IVD Registration (CIVDR): For higher-risk devices.
  • Validity: Class B, C, and D CIVDRs (after renewal/initial registration) are valid for 5 years.

The initial processing time for a CIVDR is approximately 180 days, while re-registration (with no data variations) can take 60 to 90 days.

Key Documentation and Legal Requirements

The application process is governed by the new draft IVD guidance and follows the ASEAN CSDT (Common Submission Dossier Template) for technical data.

1. Local Registrant: Applications must be submitted by a licensed local importer, distributor, or manufacturer, who will subsequently hold the CIVDR/CIVDN.
2. Foreign Approval: Proof of regulatory approval in the country of origin is required. Reference Country approval (e.g., US, EU, Canada, Japan, Australia) may be used instead.
3. Authentication: Certain documents, such as the Certificate of Free Sale (CFS) (which may be eliminated), ISO certificate, and Foreign Agency Agreement, must be authenticated by the territorial Philippine Consulate. This step is often a major bottleneck, potentially taking 4 to 12 weeks.
4. Quality System: Documentation of quality systems conformity assessment is required, typically an ISO 13485 certificate or an audit report from a recognized agency (e.g., FDA EIR, Japanese PMDA).

Mandatory In-Country Testing

A crucial aspect of the draft IVD regulations is the requirement for in-country performance testing for higher-risk IVD devices:

• Requirement: Applications for Class B, C, and D IVDs will need to be endorsed by a Philippines FDA-accredited laboratory (such as the Research Institute of Tropical Medicine, RITM) for performance evaluation.
• Cost: Testing fees are separate from the FDA's application fees.