Registration Renewal: The 90-Day Window and the Consequences of 120-Day Overdue

1. Key takeaways

Both the CMDN and the CMDR are valid for 5 years, and the renewal application has to be filed within 90 days before expiry. Late filing is penalised under FC No. 2011-004, with a doubled renewal fee plus a monthly surcharge. Where renewal is filed more than 120 days after expiry, the application is no longer accepted and the product has to go through an initial application again, and in the meantime sale and distribution must stop.

• The 90-day window is the earliest point at which a renewal may be filed, not a reminder date. Filing earlier is not accepted.
• Beyond 120 days after expiry the file is treated as a new initial application, with the full dossier and the full fee.
• Under FDA Advisory No. 2026-1007, a renewal filed on time within the validity period keeps the certificate in force while the FDA reviews it.
• Renewal is not a fee-and-collect exercise: post-market surveillance and adverse event summaries are part of the submission.
• Three dates should be diarised on the day the certificate is issued: the 5-year expiry, the first day of the 90-day window, and the 120-day cliff.

2. Legal basis

Validity of 5 years applies to both certificate types, with the renewal window fixed at 90 days before expiry. Late renewal is governed by FDA Circular No. 2011-004, which provides for a doubled renewal fee plus a monthly surcharge. The outer limit is 120 days: beyond that point the renewal is not accepted and an initial application is required. The fee rules in the draft AO 2024-0016 state a penalty of twice the renewal fee plus 10 per cent for each month, with a part month counted as a full month, running from the original expiry date for a maximum of 120 days. FDA Advisory No. 2026-1007 provides that a renewal filed on time within the validity period leaves the certificate in force during review. The fee currently applied is the AO No. 50 s. 2001 rate of PHP 1,010 per year over the 5-year term.

3. Expert insights

The 90-day window is a hard window, not a reminder. Many Chinese manufacturers read the 90 days before expiry as an instruction to send a reminder three months ahead. It is in fact the earliest date on which the submission may be lodged; anything earlier is not accepted by the FDA. The correct approach is to have the package ready in advance, then file on or as soon as possible after the first day of the window. Treating the window as a starting gun rather than a deadline is the whole discipline.

The 120 days is a cliff, not a slope. The relationship between the numbers is straightforward. Filing within 90 days before expiry is a normal renewal. Filing within 120 days after expiry is acceptable but attracts the penalty. Filing more than 120 days after expiry is not accepted, the product must be registered again through an initial application, and sale and distribution must stop until the new certificate is issued. Between paying a penalty and pulling a product from the market there is only one line, and it is crossed quietly if nobody is watching the calendar.

Advisory No. 2026-1007 provides the reassurance that makes timely filing worthwhile. According to FDA Advisory No. 2026-1007, as compiled from third-party sources and subject to confirmation against the official text, a renewal filed on time within the validity period means the certificate is treated as continuing in force while the FDA reviews the application. That matters because it removes the gap in which a certificate has expired but the replacement has not yet been issued. It also underlines the value of filing on time: the protection is not available to a late applicant.

Renewal is not simply paying a fee for a new certificate; post-market material is required. The renewal submission includes post-market surveillance and adverse event summaries, and the weight of that material has increased since AO No. 2025-0030 took effect. The MAH has to be able to produce complete import and distribution records, complaint handling records, and AE and FSCA records. A company that does not manage records during the life of the certificate will find the renewal blocked at exactly the point where the clock is running.

4. Practical recommendations

• Open an expiry ledger on the day the certificate is issued. Record three dates: the 5-year expiry, the first day of the 90-day filing window, and the 120-day cliff.
• Start preparation six months ahead. Complete the post-market surveillance summary, the change log and the technical file update before the window opens, so that the submission date is not set by drafting speed.
• Merge renewal and post-market record management into one process. The records required by AO No. 2025-0030 are the same records that feed the renewal submission, so running them as one workflow removes duplicate effort and reduces the risk of a gap.
• Never let a file pass the 120-day line. As soon as the date approaches, decide whether to convert to a fresh registration, and notify the distribution channel to stop supply while that decision is being made.
• Keep evidence of the filing date. The protection under Advisory No. 2026-1007 depends on the renewal having been filed on time, so the submission receipt is a regulatory document, not just an administrative record.

5. Verification checklist

• □ Certificate expiry date confirmed against the original certificate.
• □ Renewal filing window confirmed as within 90 days before expiry.
• □ Outer limit of 120 days understood and diarised.
• □ Penalty basis confirmed under FC No. 2011-004, subject to the current reading in force.
• □ Effect during review confirmed under FDA Advisory No. 2026-1007.
• □ Post-market package assembled: import and distribution records, complaints, AE and FSCA summaries.
• □ Current renewal fee confirmed at the AO No. 50 s. 2001 rate of PHP 1,010 per year across 5 years.

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