Philippines FDA Clarifies CPR Validity During Device Renewal

The Philippines Food and Drug Administration (FDA), through the Center for Device Regulation, Radiation Health, and Research (CDRRHR), issued FDA Advisory No. 2026-1007 on 28 July 2026. The signed PDF is marked original copy signed by Director General Atty. Paolo S. Teston (DTN 20260630133516).

The addressees are all concerned stakeholders, including manufacturers, traders, distributors, importers, customs authorities, procuring entities, and other government agencies.

Point 6 states the Advisory's legal status expressly: the Advisory “is issued solely to clarify the existing provisions of the IRR of RA No. 9711 and does not amend, modify, or create additional rights, obligations, or requirements beyond those provided under existing laws, rules, and regulations.” It is not a new fee circular and it is not an extension of the separate CMDR fee-suspension instruments.

What the IRR sentence says

FDA quotes Book II, Article I, Section 3.B, Item (2) of the Implementing Rules and Regulations of Republic Act No. 9711 (the FDA Act of 2009):

For applications for renewal filed from within one hundred twenty (120) days from its original expiry, the CPR shall be considered valid and existing until a decision or resolution by the FDA is rendered on the application for renewal.

Pure Global verified this sentence as quoted in the Advisory. We did not independently verify it against a separate copy of the full IRR.

The six clarifications

1. A Certificate of Product Registration (CPR) for a medical device that has reached its expiration date continues to be considered valid and existing pending FDA action if both are true: (a) the renewal application was filed within 120 days from the original expiry date of the CPR; and (b) the applicable renewal fees, surcharges, and penalties, if any, have been paid.
2. That continued validity remains only until FDA renders a decision or resolution on the renewal.
3. A renewal filed beyond 120 days from the original expiry date shall be considered expired and is subject to the IRR’s initial filing and evaluation procedures.
4. For importation, procurement, public bidding, supply and delivery of medical devices, and other transactions that require proof of product registration, the holder may present (a) proof of submission or acknowledgment of the renewal application issued by FDA, and (b) proof of payment of the applicable renewal fees, including surcharges and penalties if applicable.
5. Those documents may be used as supporting evidence that the CPR is deemed valid and existing under the quoted IRR provision, without prejudice to the receiving agency or entity verifying authenticity and status with FDA.
6. Status language as quoted above: clarification only; no new rights or duties.

Pure Global reading of the 120-day clock: the window is measured from original expiry, not as a duty to file before expiry. A file submitted after the printed expiry date can still fall within that 120-day period. A file submitted outside that period cannot rely on this continued-validity rule. The Advisory does not say whether the 120 days are calendar days or working days; the IRR sentence as quoted uses “days” only.

What this is not

It is not a promise that every pending renewal will be granted. Validity lasts until FDA decides. A refusal or other resolution ends the “valid and existing” status on the terms of that decision.

It does not state surcharge rates, documentary checklists, or portal steps. It does not change the government fee schedule. Pure Global’s earlier Philippines items on 2025 fee suspension and the 2026 CMDR fee-suspension extension are different events.

What holders and importers should do now

1. Count 120 days from the CPR’s original expiry, not from a hoped-for FDA approval date, and file inside that window if continued validity during review is needed.
2. Pay the applicable renewal fees, surcharges, and penalties before relying on point 1. Unpaid files are outside the clarification.
3. Keep the FDA acknowledgment and the proof of payment with import, bid, and supply packs. Points 4 and 5 allow those documents to be shown; they also allow the receiving body to check them with FDA.
4. Do not treat a pending file as an open-ended licence. Point 2 ends continued validity when FDA decides.
5. If the 120 days have already passed, plan an initial filing under the IRR rather than a late renewal under this Advisory.

Philippine market-access context is on Pure Global’s Philippines page. The controlling texts are the Advisory landing page and the signed PDF.