Philippines Labelling and IFU Requirements: Ten Elements and Verification

1. Key takeaways

Philippine medical device labels must be in English, with Filipino optional, and labels containing Chinese are not accepted. A label must carry ten elements: the product name and model; the CMDN or CMDR registration number; the name and address of the manufacturer and of the local licence holder; the country of origin; the batch or serial number; the date of manufacture and the expiry date; the sterilisation status and method where applicable; storage conditions; warnings and precautions; and the intended use. For imported products, sticker labelling may be used to add local information.

GRZAN note: labelling used to be a document problem settled at submission. It is now an inspection problem as well, because the label on the product in the market can be compared against the approved version. The requirement set can be remembered as 10 elements, 1 hard language rule, and 2 deadlines that start the moment a mismatch is found.

• Labels in English, with Filipino optional and no Chinese permitted;
• Ten mandatory elements on every label;
• Diagnostic or radiation-emitting devices must state their nature and intensity;
• Sticker labelling permitted for imported products;
• Labels submitted as colour images.

The operational consequence is that label artwork should be treated as a controlled technical document rather than as a packaging decision taken close to shipment. Once approved, the artwork becomes the benchmark against which the physical product is judged, and any subsequent change has to be reconciled with that benchmark rather than with the previous printer file.

2. Legal basis

The labelling requirements, the permitted import mechanism and the post-market verification regime are summarised below. The last two rows are the ones that changed most recently, and they are the reason labelling now belongs in the compliance discussion rather than the logistics one.

3. Expert insights

Insight 1: from 2026 the label moves from submission material to verifiable object. In the past, labelling problems generally surfaced during the application stage. AO No. 2025-0030 and the accompanying draft circular establish a physical product verification mechanism: the FDA checks whether the label on product actually in circulation matches the approved version. Where it does not, a warning letter is issued to the MAH, an FSCA report form must be submitted within 14 calendar days, and corrective action must be completed within 60 calendar days. The market cost of a labelling error has therefore risen sharply.

Insight 2: the registration number is the identity document on the label, and its format matters. Public health warnings issued by the FDA describe the registration number formats the public should look for, including DVR-xxx, MDR-xxx, IVDR-xxx and RR-xxx. The registration number must be printed clearly on the label and its format must match the certificate. A missing number or a wrong format will be stopped at customs clearance and in tender processes, where the number is checked against the certificate before the product is accepted.

Insight 3: sticker labelling is a compliance tool, not an expedient. Sticker labelling is used to add locally required elements — the licence holder name and address, the registration number, storage conditions — without altering the original packaging. Its compliance conditions are that the added content matches what was approved and that the sticker does not obscure any mandatory element of the original label. The sticker arrangement should be submitted and confirmed at the application stage together with the label specimen, rather than improvised at the point of import.

Insight 4: labels must be submitted as colour images. Both CMDN and CMDR require labels to be provided as colour images. This is not formalism: the reviewer needs to see how the label actually presents, including type size, contrast and layout. Black-and-white copies or low-resolution screenshots will be returned, and the return costs a full submission cycle for a defect that could have been avoided at the point of scanning.

4. Practical recommendations

• Finalise the label at the submission stage. File an English label specimen so that later changes are avoided.
• Submit the sticker arrangement together with the label specimen. Handling it at import is too late.
• Maintain a label version register. Record every approved version, and compare before implementing any revision.
• Carry out periodic physical self-checks after launch. Compare against the approved version item by item to avoid triggering a warning letter.
• Submit clear colour images. Do not use black-and-white copies or screenshots.

In combination, these practices close the gap between what is approved and what is actually on the shelf. That gap is usually created by ordinary events — a packaging revision, a change of printer, a new licence holder — rather than by any deliberate decision, which is precisely why a version register and a periodic physical check catch more problems than a single careful review at launch.

5. Verification checklist

• □ Label language is English, with no Chinese present
• □ All ten elements present, checked item by item
• □ Registration number format correct and consistent with the certificate
• □ Special marking for radiation-emitting or diagnostic devices states nature and intensity
• □ Colour images submitted, complete and legible
• □ Sticker arrangement, where used, consistent with the approved content
• □ Physical product periodically compared against the approved version

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including the Philippines. Our team prepares CMDN/CMDR dossiers to ASEAN CSDT structure, manages submissions and deficiency responses with the FDA Philippines, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com