Labelling Requirements
DOH AO 2018-0002 · CDRRHR · English required · PH-Unique
Overview
Medical device labelling in the Philippines is governed by DOH AO 2018-0002 and CDRRHR guidelines. All labelling must be in English. Filipino (Tagalog) may be added but does not replace English.
Mandatory Label Elements
The following must appear on the device label or outer packaging:
| Element | Requirement |
|---|---|
| Device trade name and model number | Required |
| Manufacturer's name and full address | Required |
| Intended purpose / intended use | Required |
| Lot or batch number | Required (preceded by "LOT" or the batch symbol) |
| Expiry date or shelf life (if applicable) | Required |
| Single-use symbol (if applicable) | ISO 7000-1051 — do not re-use symbol |
| Sterile symbol (if applicable) | ISO 15223-1 sterilisation method symbol |
| Date of manufacture (if no expiry given) | Required |
| CMDN or CMDR certificate number | Required post-approval — must appear on outer packaging |
| Philippines importer / distributor name and address | Required |
| Warnings, contraindications, and precautions | Required — derived from risk management |
| Conditions for radiation-emitting devices | Required for applicable devices |
Instructions for Use (IFU)
An IFU must be included unless the device is sufficiently simple that it can be used safely without written instructions. IFU must cover:
- Intended purpose and patient population
- Contraindications and precautions
- Method of use / operating instructions
- Cleaning, disinfection, and sterilisation (if reusable)
- Storage conditions
- Disposal instructions (for single-use or hazardous devices)
Electronic IFU (eIFU): The Philippines does not currently have a formal eIFU policy allowing omission of paper IFU. Include a paper IFU unless CDRRHR has issued specific guidance for the device type.
Claims — Advertising and Promotional Claims
Device claims (performance, clinical benefit, safety) must be:
- Supported by substantial evidence — clinical data, validated test results, or published literature
- Consistent with the intended purpose stated in the approved CMDN/CMDR
- Not misleading — CDRRHR may take enforcement action against unsubstantiated or false claims
Claims must not go beyond what is supported by the technical documentation submitted and approved. Post-approval promotional materials are subject to CDRRHR review.
Label Review During Registration
Labelling is reviewed as part of the CMDN/CMDR application — the Philippines-compliant label is submitted in Section 8 of the CSDT. CDRRHR may issue deficiencies for:
- Missing mandatory elements
- Claims not supported by the dossier
- Incorrect or misleading intended purpose
- Non-compliant format or language
Address label deficiencies within the 90-day deficiency response window to avoid abandonment of the application.
Post-Approval Label Changes
Significant labelling changes (new warnings, change in intended purpose, new contraindications) require a variation application to CDRRHR before implementation. Minor administrative changes should be confirmed with CDRRHR before proceeding without a variation.
Import Labelling — PH-Unique
Imported devices must carry Philippines-specific labelling including:
- The name and address of the Philippines importer/distributor
- The CMDN/CMDR number
This information may be added via an additional label affixed to the outer packaging without altering the original manufacturer label, provided the original label remains legible and the additional label does not obscure mandatory information.