Clinical Evidence
DOH AO 2018-0002 · ASEAN AMDD · Clinical Evaluation Report (CER)
Overview
Clinical evidence requirements in the Philippines follow the ASEAN Medical Devices Directive (AMDD) framework. The level of evidence required scales with device risk class.
Requirements by Device Class
| Class | Risk | Clinical Evidence Required |
|---|---|---|
| A | Low | Generally none — Essential Principles declaration sufficient |
| B | Low-moderate | Clinical Evaluation Report (CER) based on literature review; clinical data for novel devices |
| C | Moderate-high | Detailed CER; clinical investigation data typically required for novel devices without equivalent |
| D | High | Comprehensive clinical evidence; rigorous CER with clinical investigation data typically required |
Clinical Evaluation Report (CER)
For Class B, C, and D devices, the Clinical Evaluation Report (CER) is the core clinical evidence document submitted in Section 7 of the ASEAN CSDT.
A compliant CER must demonstrate:
- The device achieves its intended clinical purpose
- Acceptable benefit-risk profile based on clinical data
- Any residual clinical risks are addressed in labelling
CER Content
| CER Section | Description |
|---|---|
| Device description and intended purpose | Clinical context of use |
| Literature search strategy | Database, search terms, date range, inclusion/exclusion criteria |
| Literature appraisal | Assessment of relevant published clinical data |
| Equivalence (if claimed) | Justification that clinical data from equivalent devices is applicable |
| Clinical investigation data | If required — summary of trial design, endpoints, and results |
| Benefit-risk conclusion | Quantified assessment of clinical benefits vs. residual risks |
| PMCF / ongoing PMS plan | Clinical follow-up plan post-registration |
Use of International Clinical Data
Philippines CDRRHR accepts clinical data generated in other countries, provided:
- The data is from well-designed studies (randomised controlled trials, prospective cohort studies, or appropriate alternatives for the device type)
- The study population and conditions of use are clinically relevant to the Philippines patient population
- Any differences between study population and Philippine population are addressed
- The data is published in peer-reviewed literature or included in the technical file
ASEAN NRA-approved data: If the device has been reviewed and approved by another ASEAN NRA (e.g. Singapore HSA, Thailand FDA), that NRA's clinical assessment can be used to support the Philippines application via the abridged pathway.
Clinical Investigations in the Philippines
Clinical investigations may be required for novel high-risk devices without a recognised equivalent. Requirements:
- Ethics Committee (EC) approval from a PHREB-accredited institutional ethics review board
- FDA Philippines approval for studies conducted in the Philippines
- Conduct must comply with Philippine Good Clinical Practice guidelines and Declaration of Helsinki
- Results must be submitted as part of the CMDR dossier
Equivalence — Using Another Device's Clinical Data
For Class B/C/D devices, clinical equivalence to a predicate device can support the CER without new clinical investigations, provided:
- Technical equivalence: same design, materials, specifications
- Biological equivalence: same materials in contact, same type of contact
- Clinical equivalence: same intended purpose, patient population, site of use, conditions
- The predicate is clearly identified and its clinical data is documented
If full equivalence cannot be demonstrated, additional clinical data from the subject device is required.
IVDs — Note on Clinical Evidence
IVDs are currently not required to register in the Philippines under the existing framework. A regulatory framework for IVD registration is under development. When implemented, IVD performance evaluation (sensitivity, specificity, precision) rather than a CER will be the evidence basis.