Technical Documentation
ASEAN CSDT · DOH AO 2018-0002 · Class A–D
Overview
All medical device applications to CDRRHR require technical documentation demonstrating that the device is safe, performs as intended, and meets the ASEAN Essential Principles. The required format differs by device class.
Class A (CMDN) — Simplified Dossier
Class A applications use a simplified technical dossier. Required documents:
| Document | Requirement |
|---|---|
| Device description and intended purpose | Required |
| Classification justification | Required — reference the applicable ASEAN AMDD rule |
| Declaration of Safety and Performance | Required — signed by manufacturer |
| Philippines-compliant label | Required |
| Letter of Authorization (LOA) from manufacturer | Required |
| Free Sale Certificate (FSC) | Required — from country of manufacture |
No clinical evidence or ISO 13485 certificate is required at the Class A notification stage, though the device must still meet the Essential Principles.
Class B/C/D (CMDR) — ASEAN CSDT Full Format
Class B, C, and D registrations require the ASEAN Common Submission Dossier Template (CSDT) in full format:
CSDT Section Summary
| Section | Content Required |
|---|---|
| 1. Administrative | Applicant details, manufacturer details, device name, model numbers, application type |
| 2. Device Description | Intended purpose, operating principle, materials, configurations, accessories |
| 3. Classification | Assigned class, applicable ASEAN AMDD classification rules, justification |
| 4. Essential Principles Checklist | Cross-reference of each requirement to supporting evidence |
| 5. Design Verification & Validation | Bench test reports, performance testing, electrical safety, EMC, sterilisation validation (if applicable) |
| 6. Risk Management | ISO 14971 risk management summary — hazard identification, risk controls, residual risk |
| 7. Clinical / Performance Evaluation | Clinical Evaluation Report (CER) for general devices; performance evaluation for IVDs when applicable |
| 8. Labelling | Philippines-compliant label (see labelling requirements) |
| 9. QMS Evidence | ISO 13485 certificate from accredited certification body |
| 10. Manufacturing Information | Manufacturing site name, address, GMP evidence / FSC |
| 11. Post-Market Surveillance Plan | Outline of PMS activities post-registration |
Essential Principles
The ASEAN Essential Principles of Safety and Performance are the equivalent of the EU GSPR — they set out what a device must demonstrate before it can be marketed. The CMDR checklist maps each essential principle to a supporting document (standard, test report, clinical data).
Key Essential Principles categories:
- General safety and performance requirements
- Design and construction safety
- Protection against radiation
- Devices with a measuring function
- Labelling and instructions for use
Risk Management
All Class B/C/D devices must include a risk management summary aligned with ISO 14971:
- Hazard identification and risk estimation
- Risk control measures and residual risk evaluation
- Benefit-risk analysis confirming net benefit
- Summary of risks reflected in labelling (contraindications, warnings, precautions)
Labelling Requirements
Labels must comply with DOH AO 2018-0002 requirements. All labelling must be in English. Required label elements:
| Element | Requirement |
|---|---|
| Device name and model | Required |
| Manufacturer name and address | Required |
| Intended purpose | Required |
| Lot/batch number | Required |
| Expiry date (if applicable) | Required |
| Single-use symbol (if applicable) | Required |
| Sterile symbol (if applicable) | Required |
| Warnings, precautions, contraindications | Required — derived from risk management |
| CMDN / CMDR number | Required on outer packaging post-approval |
| Filipino distributor / importer name | Required |
Instructions for Use (IFU) must be included unless the device can be used safely without them (e.g. simple Class A devices).
Letter of Authorization (LOA) — PH-Unique Requirements
The LOA from the foreign manufacturer is a critical document:
- Must be executed by the legal manufacturer's authorised signatory
- Must include a notarised declaration confirming the device meets Essential Principles and that technical data is accurate
- Apostille or consular authentication of the notarisation may be required depending on the country — verify with CDRRHR
- Authorises the named Philippines entity to hold the CMDN/CMDR on the manufacturer's behalf
Free Sale Certificate (FSC)
FSC (or Certificate of Free Sale / CFS) from the regulatory authority of the country of manufacture. Must confirm the device is legally marketed in that country and is not subject to recall or suspension. Must be current at time of submission.
Abridged Route — Reusing CSDT from Other ASEAN Markets
If the device has been approved by an ASEAN NRA, the same CSDT used for that submission can form the basis of the Philippines application. This unlocks the 30-day abridged review. Minor Philippines-specific adaptations (labelling, LOA format) are required. See Abridged Pathway.