Philippines FDA Advisory 2026-1007: CPR Validity, 120-Day Clock & CMDN/CMDR

Operational guide to FDA Advisory 2026-1007: CPR validity during renewal, RA 9711 IRR 120 days, customs proof, CMDN/CMDR 90-day filing, and fee suspension.

On 28 July 2026, the Food and Drug Administration (FDA) of the Philippines, acting through the Center for Device Regulation, Radiation Health, and Research (CDRRHR), issued FDA Advisory No. 2026-1007 (Document Tracking Number DTN 20260630133516; original copy signed by Director General Atty. Paolo S. Teston). Titled "Clarification on the Continued Validity of Certificates of Product Registration (CPRs) for Medical Devices Pending FDA Resolution of Renewal Applications," the signed PDF addresses manufacturers, traders, distributors, importers, customs authorities, procuring entities, and other government agencies. It is a clarification of existing Implementing Rules and Regulations (IRR) text, not a new marketing authorization.

For medical device regulatory affairs directors, supply chain managers, and in-country Authorized Representatives (License to Operate / LTO holders), the issuance of Advisory 2026-1007 addresses an urgent commercial and operational bottleneck. In routine practice, CDRRHR renewal evaluation timelines can extend well past the printed expiration date of an authorization. Historically, shipments facing expired printed dates frequently suffered port impoundment by the Bureau of Customs (BOC), disqualification during hospital tenders under the Philippine Government Electronic Procurement System (PhilGEPS), or distributor delivery freezes.

However, Advisory 2026-1007 is neither a blanket license extension nor a free pass to postpone regulatory filings. It is a precise restatement of existing statutory rights under the Implementing Rules and Regulations (IRR) of Republic Act No. 9711, conditioned upon strict submission timing and fee payment verification.

This guide provides an operational analysis of Advisory 2026-1007, dissects the 120-day post-expiry filing window versus Administrative Order No. 2018-0002's 90-day pre-expiry window, explains the two documents Point 4 says holders may present for import and procurement, models the late surcharge formula under FDA Circular No. 2011-004, and separates these validity rules from the fee-schedule suspension under Department Circular No. 2026-0329.

This analysis expands MedDeviceGuide's Southeast Asian regulatory series, including our foundational Philippines medical device registration guide, the ASEAN AMDD regional registration guide, the ASEAN CSDT dossier guide, the ASEAN distributor qualification matrix, and our comparative international device registration cost benchmark.

Direct Answer: What Did Advisory 2026-1007 Establish for Medical Device Shipments?

FDA Advisory 2026-1007 confirms that a medical device Certificate of Product Registration (CPR) that has reached its expiration date continues to be considered valid and existing pending FDA action, provided two conditions in Point 1 are met:

Timely submission: The renewal application has been filed within one hundred twenty (120) days from the original expiry date of the CPR.
Payment: The applicable renewal fees, surcharges, and penalties, if any, have been paid. Legal Research Fee (LRF) is not named in Point 1(b); it is a separate 1% add-on under FDA Circular No. 2011-004.

When both conditions are satisfied, Point 2 keeps that continued validity in effect only until the FDA renders a decision or resolution on the renewal. If FDA disapproves the application, deemed validity ends on that decision. If a renewal is filed beyond 120 days from original expiry, Point 3 treats the CPR as expired and sends the file to initial filing and evaluation under the IRR of RA 9711.

The Decision Matrix: Keep Shipping vs. Stop

Scenario / Filing Status	Filing Timing vs. Original Expiry	Fee Payment Status	Legal Status of CPR	Commercial Action Allowed
Timely standard renewal	Filed within 90 calendar days prior to expiry (AO 2018-0002)	Paid in full; no 2011-004 surcharge	Still inside printed validity; 2026-1007's post-expiry rule is not needed	Keep shipping. Keep the acknowledgment and payment proof in the file.
Post-expiry timely renewal	Filed 1 to 120 days after printed expiry	Paid in full, including Circular 2011-004 surcharges	Considered valid and existing until FDA decision (Points 1–2)	Keep shipping, importing, and bidding. Present both Point 4 documents.
Pending but unpaid file	Filed within 120 days from expiry	Unpaid or partially paid	Not deemed valid. Fails Point 1(b)	Do not treat the file as a live CPR. Point 4(b) also requires proof of payment.
Late filing (Day 121+)	Filed more than 120 days after printed expiry	Any status	Expired. Point 3; initial filing under the IRR	Stop importation and supply until a new initial authorization is issued. For CMDR, AO 2018-0002 B.3 says the same stop-sale rule.
FDA Notice of Disapproval (NOD)	Any prior timing	Paid	Ended. Point 2: continued validity lasts only until FDA decides	Cease distribution. Advisory 2024-0009 allows a 30-day renewal re-application; that re-file is not a second deemed-valid CPR.

The Two Documents for Customs and Tender Release

For importation, procurement, public bidding, supply and delivery, and other transactions that require proof of product registration, Point 4 says the holder may present the following two documents as evidence that the CPR remains valid and existing pending FDA action:

Proof of submission or acknowledgment of the renewal application issued by the FDA.
Proof of payment of the applicable renewal fees, including surcharges and penalties, if applicable.

The advisory does not name LandBank, BancNet, or a specific eServices screen. Those are typical FDA payment channels (the CDRRHR Citizen's Charter lists FDAC cashier, BANCNET, and LandBank On-Coll as examples). Point 5 adds that presenting the two documents is supporting evidence without prejudice to the receiving agency's authority to verify authenticity and status with FDA.

Is Advisory 2026-1007 a New Medical Device Licence, or a Clarification of RA 9711 IRR Section 3.B(2)?

A frequent misconception among international MedTech regulatory teams is that Advisory 2026-1007 represents a temporary regulatory waiver, an administrative forbearance program, or a new marketing authorization certificate. It is none of these.

Advisory 2026-1007 is an administrative clarification of long-standing statutory law. Specifically, it quotes and interprets Book II, Article I, Section 3.B, Item (2) of the Implementing Rules and Regulations (IRR) of Republic Act No. 9711 (the Food and Drug Administration 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."

That sentence is quoted in Advisory 2026-1007 from the IRR and matches Book II, Article I, Section 3.B, Item (2) of the fda.gov.ph IRR PDF. Point 6 then limits the advisory itself:

"This 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."

Why CDRRHR Issued the Clarification in 2026

Although Book II, Section 3.B(2) has existed in the RA 9711 IRR since its promulgation, operational enforcement across Philippine borders and healthcare procurement systems has suffered chronic fragmentation:

Customs Impoundment: Port drug controllers and Bureau of Customs examiners frequently operated under rigid checklists requiring a CPR with a future calendar date, declining to clear imported medical device containers when presented with renewal tracking slips.
Public Procurement Disqualification: Government hospital bids governed by Republic Act No. 9184 (the Government Procurement Reform Act) routinely disqualified bidders whose authorizations showed an expired face date, fearing audit disallowances from the Commission on Audit (COA).
Institutional Verification Queries: In-country Authorized Representatives spent weeks securing customized "Certificate of Pending Renewal" letters from CDRRHR to unblock individual hospital supply contracts.

By issuing Advisory 2026-1007, the Director General put that IRR sentence in a document that names customs authorities and procuring entities in the addressee block. Point 4 still uses "may be presented," and Point 5 preserves the receiving body's right to verify with FDA. The advisory is not a new CPR, a grouping circular, or an LTO rewrite.

What Are the Two Conditions for a Deemed-Valid Expired CPR, and Which Two Proofs May Customs and Procuring Entities See?

The operative legal protection conferred by Advisory 2026-1007 rests upon two strict cumulative criteria, followed by two evidentiary proofs:

Statutory Requirement	Legal Rule under Advisory 2026-1007	Evidentiary Standard	Operational Risk if Missing
Condition 1: Timing	Renewal filed within 120 days from original CPR expiry (Point 1(a)).	eServices timestamp or CDRRHR receiving copy.	Filed after that window: Point 3, initial filing.
Condition 2: Payment	Applicable renewal fees, surcharges, and penalties paid (Point 1(b)).	Order of Payment plus bank/cashier proof.	Acknowledgment without payment proof does not satisfy Points 1(b) and 4(b).
Proof document A	Proof of submission or acknowledgment issued by FDA (Point 4(a)).	DTN slip or equivalent FDA acknowledgment.	Point 4 is optional evidence, not a substitute for a paid file.
Proof document B	Proof of payment of applicable fees, including surcharges if any (Point 4(b)).	Receipt matching the assessment.	Receiving agencies may still verify with FDA (Point 5).

Condition 1: Filing Within 120 Days of Original Expiry

The application for renewal must be filed within 120 days following the original expiry date. That is a filing window, not FDA's review SLA and not a cap on how long deemed validity lasts after a timely, paid filing:

It is pegged to the original expiry date of the CPR (the IRR's "original expiry").
Advisory 2026-1007 does not add a weekend or holiday extension. If day 120 falls on a non-working day, confirm the receiving rule with CDRRHR rather than assuming a next-business-day save.
A renewal filed before expiry (including inside AO 2018-0002's 90-calendar-day pre-expiry window) is inside the IRR's 120-day window.

Condition 2: Full Payment of Renewal Fees, Surcharges, and Penalties

Under Point 1(b), a renewal submission that has been uploaded to the FDA portal but remains unpaid does not trigger deemed validity:

Filing without payment generates a preliminary tracking reference but does not constitute an accepted administrative application.
If the renewal is lodged after the printed expiry date, the payment must include the statutory late filing surcharges mandated under FDA Circular No. 2011-004. An applicant who pays only the base renewal fee and ignores the monthly surcharge accrual fails Condition 2.

The Two Proof Documents in Point 4

When participating in public bidding or clearing goods through customs, Point 4 of Advisory 2026-1007 lists the documents the holder may present:

Proof of submission or acknowledgment issued by FDA. In practice this is often the eServices Document Tracking Number (DTN) acknowledgment, or a CDRRHR receiving copy for a manual filing. The advisory does not prescribe the screen title.
Proof of payment of applicable renewal fees, including surcharges and penalties if applicable. Typical channels are the FDA Order of Payment settled at FDAC cashier, BANCNET, or LandBank On-Coll. The receipt should match the assessment, including LRF and any 2011-004 surcharge actually charged.

Verification Rights Under Point 5

Point 5 is a verification reservation, not a command that procuring entities skip due diligence. Bureau of Customs examiners, hospital bids and awards committees, and private consignees may still check authenticity and status with FDA. Do not ship on a verbal "pending renewal" email.

Is the 120-Day Window Counted From Original Expiry, From Filing, or From Hoped-For FDA Approval?

One of the most dangerous operational errors observed in Philippine regulatory operations is the conflation of different administrative clocks. MedTech executives frequently ask whether the 120-day period begins upon filing, or whether FDA has 120 days to complete its review.

The statutory rule is narrower than the hallway version: the 120-day figure is the filing window measured from original expiry. It is not the number of days FDA has to finish the review, and it is not a cap on how long a timely, paid file stays deemed valid. After a Point 1 filing, Point 2 keeps continued validity in place until FDA decides, which can be after day 120 of the certificate.

Deconstructing the Distinct Philippine Regulatory Clocks

Regulatory affairs managers must track these separate clocks:

Regulatory Clock	Timeframe & Unit	Governing Instrument	Operational Focus & Trigger	Legal Consequence
Pre-expiry renewal window	90 calendar days prior to expiry	AO 2018-0002, Renewal item 1	Opens 90 calendar days before CMDR or CMDN expiry.	Timely renewal filing. No 2011-004 late-renewal surcharge for a file received before expiry.
Post-expiry filing window	120 days from original expiry	RA 9711 IRR Book II, Art. I, Sec. 3.B(2); Advisory 2026-1007 Point 1. AO 2018-0002 Renewal item 3 is the CMDR stop-sale rule after day 120, not a second deemed-validity sentence.	Last day to file a renewal that still uses the 120-day safety net.	CPR: Points 1–2. CMDR: item 3 still treats a file inside 120 days as a renewal (with item 2 fines), and stops sale only after day 120.
Deemed-validity duration	Until FDA decision, not until day 120	Advisory 2026-1007 Point 2	Starts only if Point 1(a)–(b) are met.	Ends when FDA grants or disapproves. A slow review does not silently expire a timely paid file.
Department fee-schedule clock	120 working days from 09 June 2026, or until EO 110 is lifted, whichever is longer	DOH Department Circular No. 2026-0329	Suspends AO 2024-0016's new FDA fee table.	Different unit (working days) and different job (fees, not CPR validity). Do not convert it into an unofficial calendar end date.

The Critical Day 121 Forfeiture

If an MAH lodges a renewal more than 120 days after expiration:

Point 3 of Advisory 2026-1007 treats the CPR as expired and applies IRR initial filing and evaluation.
For CMDR, AO 2018-0002 Renewal item 3 independently says a renewal filed after 120 calendar days from expiration shall not be accepted and shall be considered an initial application; distribution and sale shall stop until the certificate of product registration is approved. The applicant may request retention of the product registration/notification number. That option does not authorize continued shipments.
AO 2018-0002 states that an initial application shall be evaluated within 180 days of filing, and a renewal within 30 days. Treat those as AO clocks, not a guaranteed 6-to-12-month blackout invented for this page.

Does CMDN/CMDR Under AO 2018-0002 Inherit the CPR Noun, or Is the 90-Day-Before Window a Different Clock?

A crucial legal distinction in Advisory 2026-1007 is its precise statutory nomenclature: throughout the entire text of the advisory, the operative legal noun is Certificate of Product Registration (CPR).

To navigate this distinction, international manufacturers must examine the evolution of medical device authorizations under the Philippine regulatory framework. For background on how classification dictates authorization format, review our analysis of CMDN vs. CMDR distinctions.

The Regulatory Nomenclature Shift: CPR vs. CMDN and CMDR

The Traditional Regime (Pre-2018): Under legacy regulations, all medical devices approved for sale in the Philippines received a Certificate of Product Registration (CPR).
The AMDD Harmonization Regime (AO 2018-0002): Promulgated to align the Philippines with the ASEAN Medical Device Directive (AMDD), Administrative Order No. 2018-0002 created a dual authorization architecture:
- Certificate of Medical Device Notification (CMDN): Mandatory for low-risk devices (Class A).
- Certificate of Medical Device Registration (CMDR): Mandatory for moderate-to-high-risk devices (Classes B, C, and D).

Does Advisory 2026-1007 Apply to CMDNs and CMDRs?

Keep the nouns separate. 2026-1007's operative term is CPR. AO 2018-0002 created CMDN (Class A) and CMDR (Classes B–D) and is not repealed by Point 6.

What the official texts actually say:

AO 2018-0002 Renewal item 1: Filing for renewal of certificates of registration or notification shall be accepted within ninety (90) calendar days prior to the expiry date of the CMDR or CMDN.
AO 2018-0002 Renewal item 2: Applications filed after the validity date shall be fined under existing rules on fees and charges.
AO 2018-0002 Renewal item 3 (CMDR, not CMDN by name): A CMDR renewal filed after 120 calendar days from expiration shall not be accepted and shall be considered an initial application. Sale and distribution stop until the certificate is approved. The holder may request retention of the registration/notification number.
IRR Book II, Section 3.B(2) / Advisory 2026-1007: The 120-day deemed-valid sentence uses the noun CPR.

So CMDR already has an express 120-day-then-initial rule in AO 2018-0002. CMDN has the 90-day pre-expiry window and after-validity fines in items 1–2, but item 3 names CMDR. Do not tell a Class A holder that Advisory 2026-1007 silently renamed every CMDN as a CPR. If CDRRHR later says CMDN is included by that name, that later instrument wins.

The 90-day window is not optional. 2026-1007 does not encourage filing after expiry. Late CMDN/CMDR filings still pick up 2011-004 surcharges under "existing rules and regulations on fees and charges."
The post-expiry safety net is certificate-specific. For a document titled CPR, use 2026-1007 Points 1–3. For a CMDR, also read AO 2018-0002 B.3. For a CMDN, do not invent a 2026-1007 coverage sentence the advisory does not contain.

Feature / Parameter	CPR named in 2026-1007	CMDR (Class B–D)	CMDN (Class A)
Primary instrument for this page	Advisory 2026-1007 + IRR 3.B(2)	AO 2018-0002 + IRR 3.B(2) as parent FDA law	AO 2018-0002 items 1–2; 2026-1007 does not name CMDN
Base validity	5 years (legacy CPR practice; AO 2018-0002 also 5 years for CMDN/CMDR)	5 years	5 years
Pre-expiry window	File before expiry to avoid 2011-004 surcharge	Within 90 calendar days prior	Within 90 calendar days prior
120-day post-expiry rule	Points 1–3 of 2026-1007	Express in AO 2018-0002 Renewal item 3	Not named in item 3 or in 2026-1007
Surcharge if filed after expiry	Circular 2011-004	Circular 2011-004 via AO 2018-0002 item 2	Circular 2011-004 via AO 2018-0002 item 2
Customs pack	Point 4 two proofs, if Point 1 is met	Same pack is the practical analog; brief the broker that the face certificate says CMDR	Same caution: the face certificate says CMDN

What Fails If You Ship With an Unpaid File, Treat Day 121 as a Late Renewal, or Quote AO 2024-0016 Fees as Payable Today?

Regulatory non-compliance in the Philippines carries steep financial penalties, administrative sanctions, and border interdictions. Below are the six primary failure modes associated with misinterpreting Advisory 2026-1007:

1. The Acknowledgment-Only Pack

Failure: An importer presents an eServices acknowledgment but no proof of payment, assuming lodging the file establishes deemed validity.
Outcome: Points 1(b) and 4(b) are not met. Receiving agencies may refuse the pack and verify with FDA (Point 5). Unauthorized importation of unregistered health products can also trigger customs seizure under the Customs Modernization and Tariff Act (CMTA); Advisory 2026-1007 does not itself cite CMTA Section 1113, so do not treat that section as the advisory's operative clause.

2. The Day-121 Renewal Attempt

Failure: A team discovers an expired CPR after the 120-day window and tries to file it as a late renewal with surcharges.
Outcome: Point 3 sends the file to initial filing and evaluation under the IRR. For CMDR, AO 2018-0002 B.3 also stops sale and distribution until a new certificate is approved. Class A CMDN initial filing uses notification requirements, not a full Class C/D CSDT, unless CDRRHR directs otherwise.

3. Continued Marketing Following a Notice of Disapproval (NOD)

Failure: CDRRHR disapproves the renewal and the manufacturer keeps shipping until year-end.
Outcome: Point 2 ends deemed validity when FDA renders a decision. Advisory 2024-0009 then allows a renewal re-application within thirty (30) calendar days from disapproval, with a new DTN and a re-application fee of PHP 1,010 inclusive of LRF. That re-application is not a continuation of 2026-1007 deemed validity.

Note on Advisory 2024-0009: CDRRHR's one-time compliance rule, then disapproval, is a process instrument. It does not state the 120-day deemed-validity rule. Initial re-application is 60 calendar days; renewal re-application is 30 calendar days.

4. Paying or Budgeting Suspended AO 2024-0016 Fee Schedules

Failure: A consultant invoices the PHP 81,000–117,000 band printed in the Philippines 101's first fee table as if those pesos were payable in September 2026.
Outcome: DOH Department Circular No. 2026-0329 keeps AO 2024-0016 suspended. Pay the amount on the current FDA Order of Payment. Do not treat either mixed table on the Philippines 101 (81k–117k versus 13.5k–19.5k) as this article's confirmed payable-today tariff.

5. Applying Food-Supplement Peso Examples from Circular 2011-004

Failure: An operations team pays the circular's worked PHP examples (food LTO / food-supplement amounts under AO 50 s. 2000).
Outcome: Those examples are not medical-device fees. Apply the 2× + 10%-per-month formula to the applicable medical-device renewal fee on the Order of Payment.

6. Overlooking an Expired Importer License to Operate (LTO)

Failure: The product file is inside the 120-day CPR window, but the establishment LTO has lapsed past its own 120-day rule.
Outcome: FDA Circular 2011-004 II.B(c) says that when an LTO renewal filed after the 120th day turns initial, existing CPRs covered by that license are not valid until the license is approved. That is an LTO problem, not a 2026-1007 waiver.

2026-1007 30/60/90-Day SKU Map: Expiry Calendar, Filing Pack, and Customs Brief

To maintain compliance and uninterrupted commercial operations across the Philippine archipelago, regulatory affairs directors should execute the following 90-day operational protocol:

Phase 1: Days 1–30 (September 2026) — Portfolio Audit & Expiry Calibration

Consolidate Registration Census: Audit all active Philippine medical device authorizations across your corporate database. Categorize each SKU into:
- Green Tier: Expiry date > 90 calendar days in the future.
- Amber Tier: Inside AO 2018-0002 pre-expiry window (0 to 90 days before expiration).
- Red Tier (Salvageable): Expired within the last 1 to 120 calendar days.
- Black Tier (Forfeited): Expired > 120 calendar days ago.
Audit In-Country MAH LTO: Confirm that your local authorized distributor, subsidiary, or independent MAH holds a valid, active FDA License to Operate as a Medical Device Importer/Wholesaler.
Isolate Black Tier SKUs: For any device past Day 120, halt shipments. Prepare an initial file: CSDT technical requirements for a CMDR, notification requirements for a Class A CMDN, unless CDRRHR directs otherwise.

Phase 2: Days 31–60 (October 2026) — Filing Execution & Surcharge Settlement

Submit Amber Tier Filings: Lodge standard renewal applications through the FDA eServices portal within the 90-day pre-expiry window to avoid all late surcharges.
Settle Red Tier Surcharges: For Red Tier SKUs, execute the renewal submission and calculate the exact late surcharge under Circular 2011-004 based on the elapsed months since printed expiry. Settle the fee via LandBank or BancNet immediately.
Verify portal status: Download the FDA acknowledgment and the payment proof. Do not treat an unpaid draft as Point 1(b).
Monitor for deficiency notices: If CDRRHR issues a deficiency letter, Advisory 2024-0009 still gives only one compliance pass before disapproval.

Phase 3: Days 61–90 (November 2026) — Customs Briefing & Procurement Packs

Assemble the import/bid pack: For Red Tier SKUs that actually meet Point 1, and for Amber Tier SKUs still inside printed validity, assemble:
- Copy of the face certificate (CPR, CMDR, or CMDN).
- FDA acknowledgment of the renewal.
- Proof of payment matching the Order of Payment (including surcharge if post-expiry).
- Copy of Advisory 2026-1007 for receiving-party briefing.
- Copy of the active importer/wholesaler LTO.
Brief In-Country Logistics Partners: Deliver the compliance pack to your designated customs clearance brokers, forwarding agents, and hospital sales distributors.
Update PhilGEPS Bidding Profiles: Ensure your tender teams include the two-document proof pack in all government hospital bid submissions to pre-empt disqualification by hospital Bids and Awards Committees (BAC).

What Does This Cost: 2011-004 Surcharge Formula Versus Suspended AO 2024-0016 Tables, LRF, and MAH Work?

Calculating the financial commitment required for a timely versus delayed Philippine renewal requires navigating two intersecting regulatory instruments: the surcharge formula of FDA Circular No. 2011-004 and the ongoing fee suspension under DOH Department Circular No. 2026-0329.

For a broader perspective on regulatory budgeting across the region, consult our ASEAN registration fee analysis.

The Surcharge Mathematical Formula: FDA Circular No. 2011-004

Under Section II.A of Circular 2011-004, a renewal received after the expiration date is assessed:

a surcharge equal to twice (2×) the applicable renewal licensing or registration fee; plus
10% of that same renewal fee for each month or fraction of a month, up to four months / 120 days. The first day of a new month counts as a whole month.

Section II.D then adds the Legal Research Fee: 1% of the renewal fee alone, but not less than PHP 10. FDA Circular No. 2011-003 points that 1% LRF to Republic Act No. 3870 (as amended). Do not compute LRF on the surcharge.

Total payable inside the 120-day window:

T = applicable renewal fee + surcharge S + LRF

where for delay month m (1 through 4):

S = (2 × renewal fee) + (0.10 × m × renewal fee)

Section II.B (after the 120th day) is a different row: Fee = initial filing fee + (2 × renewal fee + 40% of the renewal fee). The previous registration is expired. Health products manufactured, imported, or distributed during the 120-day surcharge period are still deemed valid; after day 120, no new transaction is allowed until the initial-style application is approved.

Period of delay after expiry	Circular 2011-004 surcharge	Total government charge (formula)
On or before expiry	None	1.0× renewal fee + LRF (1%, min PHP 10)
Month 1 (days 1–30)	2× + 10% = 2.1× renewal fee	3.1× renewal fee + LRF
Month 2 (days 31–60)	2× + 20% = 2.2×	3.2× renewal fee + LRF
Month 3 (days 61–90)	2× + 30% = 2.3×	3.3× renewal fee + LRF
Month 4 (days 91–120)	2× + 40% = 2.4×	3.4× renewal fee + LRF
After day 120	II.B: 2× renewal + 40% of renewal, plus initial filing fee	Initial fee + 2.4× renewal fee + LRF. Not a renewal.

The Fee Schedule Reality: DOH Department Circular No. 2026-0329

A critical source of industry confusion is the payable base renewal fee. In 2024, DOH issued Administrative Order No. 2024-0016, a new FDA fee schedule. The Philippines 101 currently prints an 81,000–117,000 PHP "application fee" band that tracks that higher schedule.

Implementation of AO 2024-0016 remains suspended. Secretary of Health Teodoro J. Herbosa, MD, signed Department Circular No. 2026-0329 (certified true copy 25 June 2026):

Operative suspension: AO 2024-0016 is suspended for another 120 working days, or until the State of National Energy Emergency under Executive Order No. 110 is lifted, whichever is longer.
Effectivity: The circular takes effect immediately beginning 09 June 2026.
Prior DCs: DC 2025-0240, 2025-0382, and 2025-0574 remain in force insofar as they are consistent.
Working days vs calendar days: Do not convert 120 working days from 9 June 2026 into a MedDeviceGuide calendar end date. As of this article's 3 September 2026 review, the suspension is still the fee-schedule rule; it is not a CPR-validity clock and it is not a fee holiday.

AO 2018-0002 points device fees to DOH AO No. 50 s. 2001 and its amendments. Pay the pesos on the current FDA Order of Payment. Do not quote FDA Circular "2001-003" as the device tariff (the LRF circular is 2011-003). Do not recycle the ASEAN 101's PHP 3,000–10,000 LTO-renewal band as a 5-year CMDN/CMDR product fee.

Comprehensive Cost Category Architecture

Separate government fees from provider costs:

Cost component	Pricing basis	Source / status as of September 2026
Applicable government renewal fee	Amount on the current FDA Order of Payment	AO 50 s. 2001 and amendments, while AO 2024-0016 remains suspended under DC 2026-0329. Confirm on the slip.
Legal Research Fee (LRF)	1% of the renewal fee, minimum PHP 10	FDA Circular 2011-004 II.D; RA 3870 as cited in FDA Circular 2011-003
Circular 2011-004 surcharge	2.1× to 2.4× of the device renewal fee (see table)	Formula only. Ignore the circular's food PHP examples.
After-day-120 initial-style fee	Initial filing fee + (2× renewal + 40%)	2011-004 II.B
Advisory 2024-0009 re-application	PHP 1,010 inclusive of LRF	Official 2024-0009 amount
In-country representative (MAH)	Commercial retainer	Provider pricing, not an FDA tariff
Customs / bid pack assembly	Notarial and broker work	Internal or provider cost

Frequently Asked Questions

If our CPR expired last month and we already filed and paid inside 120 days, may we keep importing until FDA decides?

Yes, if it is a CPR that meets Point 1. Under Point 1 of FDA Advisory No. 2026-1007 and Book II, Article I, Section 3.B(2) of the RA 9711 IRR, that CPR is considered valid and existing until FDA decides. Present both Point 4 documents. If the face certificate is a CMDN, 2026-1007 does not name it; if it is a CMDR, also read AO 2018-0002 Renewal item 3.

Does Advisory 2026-1007 automatically apply to every CMDN and CMDR?

Not by that name. Advisory 2026-1007's operative noun is Certificate of Product Registration (CPR). AO 2018-0002 remains the device-authorization order: CMDN for Class A, CMDR for Classes B–D, 90 calendar days prior for renewal filing, and after-validity fines. CMDR has its own 120-day-then-initial stop-sale rule in AO 2018-0002 Renewal item 3. CMDN is not named in that item or in 2026-1007. Do not treat Point 6 as a silent renaming of every CMDN.

Is AO 2018-0002's 90-day pre-expiry filing window repealed?

No. Point 6 says the advisory does not amend, modify, or create additional rights beyond existing law. AO 2018-0002 Renewal item 1 still accepts CMDN/CMDR renewal filing within 90 calendar days prior to expiry. The 120-day post-expiry provision is a surcharge-bearing safety net for certificates the instruments actually name, not permission to skip the pre-expiry window.

What happens if we file on day 121 after original expiry?

If a renewal is lodged more than 120 days after original expiry, Point 3 classifies the CPR as expired and applies IRR initial filing and evaluation. For CMDR, AO 2018-0002 B.3 independently refuses the renewal, treats it as initial, and stops distribution and sale until a new certificate is approved. The optional request to retain the old number is not a shipping license. Class A CMDN initial filing follows notification requirements, not an automatic Class C/D CSDT dump.

Are the PHP 81,000-117,000 Philippines 101 figures the government fees we pay in September 2026?

No. Those figures sit on the Philippines 101's first fee table and track the AO 2024-0016 band. Under DOH Department Circular No. 2026-0329 (effectivity beginning 09 June 2026), AO 2024-0016 remains suspended for another 120 working days or until EO 110 is lifted, whichever is longer. Pay the amount on the current FDA Order of Payment. The 101's second table (PHP 13,500–19,500 initial / PHP 15,300 renewal) and the ASEAN 101's PHP 3,000–10,000 LTO band are not this article's confirmed September 2026 product-renewal tariff. Add 1% LRF (minimum PHP 10) and, if you filed after expiry, the 2011-004 formula.

Can we use the two proof documents forever if FDA is slow?

Only until the FDA renders a decision or resolution. Under Point 2, continued validity lasts only while the application is pending. A slow review does not silently kill a timely paid file. When FDA grants a new certificate or issues a disapproval, deemed validity ends. A 2024-0009 re-application after disapproval is a new file, not an extension of Point 2.

How Pure Global Supports Philippines Medical Device Regulatory & Commercial Compliance

Navigating the complexities of Philippine medical device lifecycle management, portal submissions, and customs compliance requires boots-on-the-ground regulatory intelligence and established liaison capabilities with CDRRHR and the Bureau of Customs.

Pure Global provides complete regulatory affairs, in-country authorized representation, and market access solutions for medical device and IVD manufacturers expanding across Southeast Asia.

Philippine Market Access & Registration Management: End-to-end compilation, review, and eServices portal submission for CMDN (Class A) and CMDR (Class B–D) applications, managed through our specialized Philippines regulatory team.
Advisory 2026-1007 Renewal & Surcharge Audits: Rigorous auditing of your active registration portfolio to ensure renewal submissions enter the 90-day pre-expiry or 120-day post-expiry windows with exact Circular 2011-004 fee and surcharge calculations.
Customs & Tender Defense Packs: Immediate preparation of verified two-document compliance packages (DTN submission proof and validated LandBank/BancNet receipts) to ensure uninterrupted container release at Manila and Cebu ports and audit-proof bidding under RA 9184.
Regional ASEAN Synchronization: Aligning your Philippine CSDT dossiers and post-market surveillance plans with neighboring authorities across Southeast Asia, including Malaysia's MDA framework and Singapore's HSA pathways.

To audit your Philippine registration portfolio or resolve an active customs hold, contact Pure Global's regulatory specialists.

Pure Global provides independent commercial regulatory affairs, authorized representation, and quality compliance advisory services. Pure Global is not the Food and Drug Administration of the Philippines (FDA Philippines), the Center for Device Regulation, Radiation Health, and Research (CDRRHR), the Department of Health (DOH), the Bureau of Customs (BOC), or a Philippine procuring entity.

Sources and Regulatory References

FDA Advisory No. 2026-1007 — Clarification on the Continued Validity of Certificates of Product Registration (CPRs) for Medical Devices Pending FDA Resolution of Renewal Applications — Food and Drug Administration of the Philippines / CDRRHR (Signed original copy by Director General Atty. Paolo S. Teston, DTN 20260630133516, stamped 28 July 2026).
Rules and Regulations Implementing Republic Act No. 9711 (The Food and Drug Administration Act of 2009) — FDA Philippines republic-act page (Book II, Article I, Section 3.B, Item (2); IRR PDF linked from that page).
Republic Act No. 9711 — The Food and Drug Administration Act of 2009 — Congress of the Philippines.
Administrative Order No. 2018-0002 — Guidelines Governing the Issuance of an Authorization for a Medical Device Based on the ASEAN Harmonized Technical Requirements — Department of Health (CMDN/CMDR, five-year validity, 90-day pre-expiry renewal, CMDR 120-day-then-initial rule in Renewal item 3, fees via AO 50 s. 2001).
FDA Circular No. 2011-004 — Computation of Surcharge or Penalty for Late Renewal of LTO and CPR — Food and Drug Administration of the Philippines (2× renewal fee + 10%/month up to 120 days; after day 120, initial fee + 2× + 40%; LRF 1% of renewal fee, minimum PHP 10).
Department Circular No. 2026-0329 — Further Extension of the Temporary Suspension of AO 2024-0016 — Department of Health, Office of the Secretary (signed Teodoro J. Herbosa, MD; 120 working days from 09 June 2026 or until EO 110 is lifted, whichever is longer).
FDA Advisory No. 2024-0009 — Revision in the Process of Application for CMDR/CMDN, Initial and Renewal — CDRRHR / FDA Philippines (one-time compliance; PHP 1,010 re-application inclusive of LRF).
Philippines Medical Device Registration Guide.
Southeast Asia & ASEAN Medical Device Registration Guide.
ASEAN AMDD & CSDT Medical Device Guide.
ASEAN Medical Device Distributor Qualification & Test Report Reuse Matrix.
Medical Device Registration Cost by Country Guide.
Malaysia MDA Medical Device Registration Guide.