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FDA Philippines · South & Southeast Asia

Philippines medical device regulatory resources

Every Philippines dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

22,779 registration records11 free resources24/25 topics with records7 regulations trackedAug 2026 fees reviewed

Everything we track for Philippines

Structured regulatory requirements

Explore all 56 source-linked facts →

24 of 25 research dimensions currently covered · 24 official sources · latest verification 2026-09-15

Market entry

D01

Authority & regime

Verified
Competent authority
FDA Philippines (Food and Drug Administration, Department of Health); the Center for Device Regulation, Radiation Health and Research (CDRRHR) is the regulatory office in charge of regulati…
Statutory regime
RA 3720 (Food, Drug, Device and Cosmetic Act) as amended by RA 9711 (FDA Act of 2009). BFAD was renamed FDA; CDRRHR is one of four regulatory centers and regulates manufacture, importation,…
2 source-linked facts
Checked 2026-08-25
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D02

Legal basis & guidance

Verified
Class B/C/D transition end
Under FDA Circular 2024 003, Class B/C/D devices not in the registrable list (FC 2020 001 A) could be marketed without CMDN only until 30 September 2024; CMDN applications ceased 1 October…
Fee schedule legal basis
The schedule of fees and charges for medical device authorization follows DOH Administrative Order No. 50 s. 2001 and its amendments and revisions; a 1% Legal Research Fee is added per FDA…
3 source-linked facts
Checked 2026-08-25
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D03

Device definition & scope

Verified
Medical device definition
Medical device means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent and calibrator, software, material or similar article intended by the manufacturer f…
IVD and refurbished devices excluded
AO 2018 0002 does not cover in vitro diagnostic and refurbished medical devices; separate Administrative Orders were to be issued for them. In practice IVDs are handled through a separate '…
2 source-linked facts
Checked 2026-08-25
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D05

Registration pathways

Verified
Route by class
Class A devices apply for Notification (Certificate of Medical Device Notification, CMDN); Classes B, C and D apply for Registration (Certificate of Medical Device Registration, CMDR, issue…
Exempt devices and CMDL
Medical devices strictly for research, clinical trial, exhibit, and/or donated brand new medical devices are exempted from Notification and Registration, but the researcher, institution and…
4 source-linked facts
Checked 2026-08-25
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D06

Reliance & recognition

Verified
Abridged processing on ASEAN NRA approvals
Class B/C/D devices with product approval issued by the NRA of any ASEAN member country under AMDD CSDT requirements receive abridged processing: complete legal requirements plus the latest…
ASEAN NRA approval as filing evidence
For imported medical devices, the 2025 CMDN/CMDR checklists require one copy of the product approval issued by the National Regulatory Agency of any ASEAN member country under the AMDD CSDT…
6 source-linked facts
Checked 2026-09-15
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D07

Economic-operator roles

Verified
Applicant and License to Operate
The applicant for CMDN/CMDL/CMDR is a manufacturer, trader, or distributor importer exporter; a License to Operate (LTO) is the FDA authorization for a person or establishment to operate in…
Legal Manufacturer and Product Owner
Legal Manufacturer means any foreign medical device establishment responsible for design, manufacture, packaging and labeling of a device placed on the market under its own name; Product Ow…
3 source-linked facts
Checked 2026-08-25
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D08

Establishment, import & distribution

Verified
Import control at point of entry
During the B/C/D transition the device establishment's License to Operate had to be presented to the Bureau of Customs officer at the point of entry and/or as part of bidding requirements;…
Unified LTO requirement
Under DOH AO No. 2020 0017 (8 May 2020, Revised Guidelines on the Unified Licensing Requirements and Procedures of the FDA, repealing AO 2016 0003), establishments must secure a License to…
5 source-linked facts
Checked 2026-08-25
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D09

Dossier requirements

Verified
Annex structure and CSDT
AO 2018 0002 prescribes Annex A (legal requirements for notification Class A and registration B/C/D) and Annex B (technical requirements for Class A notification); Annexes C, D and E contai…
Class A notification checklist (imported devices)
Class A CMDN checklist (2025): notarized Agreement/Letter of Authorization; for imported devices a valid government issued quality certificate or ISO 13485 certificate (product in scope, no…
3 source-linked facts
Checked 2026-08-25
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D10

Official forms & portals

Verified
eServices portal for initial CMDN
Initial CMDN applications for medical devices must be filed online through the FDA eServices Portal System at https://eservices.fda.gov.ph/; the Circular does not cover CMDN renewal and var…
CMDR submission channel
For Class B, C and D devices, initial applications for CMDN are no longer accepted; applicants are required to apply for a Certificate of Medical Device Registration (CMDR), with applicatio…
2 source-linked facts
Checked 2026-08-25
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Submission & evidence

D11

Label, IFU & language

Verified
Label and IFU evidence in dossier
Applications must include clear colored pictures of the label from all sides of the packaging (loose labels or artworks of all layers) and package insert/brochure; lot/batch/serial numbers…
National labeling requirements
Product labels of devices with issued CMDR or CMDN must carry, prior to sale and distribution: (a) name and address of the importer; (b) name and address of the distributor (if exclusive di…
2 source-linked facts
Checked 2026-08-25
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D12

QMS, audit & inspection

Verified
Establishment inspection regime
Licensed device establishments are subject to FDA inspection: retailers face routine or spot check inspections verifying storage/distribution SOPs, qualified person credentials and product…
ISO 13485 evidence for imported devices
For imported medical devices, applications require one copy of a government issued certificate attesting to the status of the manufacturer regarding competence and reliability of personnel…
2 source-linked facts
Checked 2026-08-25
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D13

Standards, testing & ancillary approvals

Unresolved
FDA electrical/EMC evidence
Electrical safety
NTC Type Acceptance
Wireless / radio
NTC Type Approval
Telecom terminal
7 maintained overlays
Open details →
Initial Certificate of Medical Device Notification - Class A
PHP 7,575
Initial Certificate of Medical Device Registration - Class B
PHP 7,575
14 maintained fee lines · 1 related fact
Checked 2026-08-25
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D15

Review clocks

Verified
Class A · Notification
23 working days
Class B · Registration
80 working days
Class C · Registration
180 days
4 maintained pathways · 1 related fact
Checked 2026-08-30
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D16

Approval validity & renewal

Verified
Transition CMDN validity (Class B/C/D)
CMDN issued for Class B, C and D medical devices under FC 2021 002 are valid for two (2) years; the company must apply for a CMDR three (3) months prior to CMDN expiration.
Authorization duration
CMDN and CMDR are valid for five (5) years and renewed every five (5) years after initial approval (AO 2018 0002 Sec. V(4)); 2025 Citizen's Charter confirms 5 year validity for CMDN initial…
4 source-linked facts
Checked 2026-08-25
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Lifecycle & post-market

D17

Change control

Verified
Notice on ceasing distribution
The distributor or local manufacturer of a device must inform the CDRRHR in writing within thirty (30) calendar days if it has ceased production or distribution of the device.
CMDN to CMDR conversion letter
When applying for CMDR for a device previously authorized by CMDN, the MAH must provide a letter stating that the application is from CMDN to CMDR, with a copy of the CMDN attached.
3 source-linked facts
Checked 2026-08-25
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D18

UDI, listing & traceability

Verified
Public list of authorized devices
The list of all approved CMDRs and CMDNs is posted on the FDA website, giving a public registry of authorized devices.
Label identification numbers
Device labels must reflect lot number, batch number or serial number, whichever is applicable, for all codes included in the application; label artworks for all packaging layers must be sub…
2 source-linked facts
Checked 2026-08-25
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D19

Clinical investigation & performance

Verified
Clinical research devices via CMDL
Devices strictly for research or clinical trial are exempt from notification/registration but require a Certificate of Medical Device Listing, applied for before importation; Class B/C/D te…
1 source-linked fact
Checked 2026-08-25
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D20

Special access & derogation

Verified
Compassionate Special Permit
CDRRHR issues a Compassionate Special Permit (CSP) for restricted use of medical devices not yet registered or in the process of registration, by patients in need of immediate medical atten…
1 source-linked fact
Checked 2026-08-25
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D21

Manufacturer PMS

Verified
Qualified person PMS duties
The establishment's qualified person must ensure observance of good storage and distribution practices, monitor inventory including expiry, ensure any adverse event is properly handled, doc…
1 source-linked fact
Checked 2026-08-25
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D22

Vigilance & incident reporting

Verified
Incident reporting to FDA
Incidents that caused or contributed to death, serious illness or serious injury of a consumer, patient or any person must be reported to the FDA through the Center for Device Regulation, R…
1 source-linked fact
Checked 2026-08-25
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D23

Recall, FSCA & market surveillance

Verified
Stop-sale duty
All retailers of medical devices must immediately stop the sale of devices banned or withdrawn for health and safety reasons in the country of origin, and those declared by FDA to be unregi…
1 source-linked fact
Checked 2026-08-25
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D24

Advertising, claims & promotion

Verified
Advertising rules (IRR RA 9711)
Under Book II, Article V of the IRR of RA 9711: no unregistered or unauthorized health product may be advertised, promoted or subjected to marketing activities; no claims may be made beyond…
Online sale/advertising of prescription devices
Online selling of prescription medical devices is prohibited; retailers may advertise prescription devices online but advertisements with a link for online purchase of prescription devices…
3 source-linked facts
Checked 2026-08-25
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D25

Submission communications & appeal

Verified
Finality and motion for reconsideration
FDA orders, rulings or decisions become final and executory fifteen (15) days after receipt by the adversely affected party unless an administrative appeal is perfected within that period;…
Appeal to Secretary of Health
FDA orders, rulings or decisions are appealable to the Secretary of Health; an appeal is perfected upon filing the notice of appeal and posting the corresponding appeal bond; the appeal doe…
3 source-linked facts
Checked 2026-08-25
Open details →

FDA Philippines registration fees in PHP · reviewed 2026-08-25

Fee lineAmountProvenance
Initial Certificate of Medical Device Notification - Class APHP 7,575Verified
Initial Certificate of Medical Device Registration - Class BPHP 7,575Verified
Initial Certificate of Medical Device Registration - Class C/DPHP 7,575Verified
Initial notification - Class B/C/D not yet included in the registrable-device listPHP 3,030Verified
10 more fee lines on the full schedule · 14 of 14 rows source-verified

Food and Drug Administration (FDA Philippines) review clocks and planning ranges · 4-class (A, B, C, D) classification

Class / pathwayReview clockPlanning totalProvenance
Class A(Notification)23 working days2-4 monthsVerified
Class B(Registration)80 working days4-9 monthsVerified
Class C(Registration)180 days6-12 monthsVerified
Class D(Full Registration)180 days9-18 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(23 working days)
  5. 5Registration Approval(1-2 weeks)

Newest official FDA Philippines headlines from the daily-refreshed feed — every row links directly to the authority publication.

Official FDA Philippines rules and guidance · 7 of 7 documents linked to official sources

AO 2018-0002Administrative Order No. 2018-0002 - Medical Devices Regulation (Full Text PDF)
GeneralVerified
FDA Circular 2021-017Reference List of Class A Medical Devices
ClassificationVerified
CMDR CharterCenter for Medical Device Regulation (CMDR) Registration Guidelines
RegistrationVerified
LTO Charter XVILicense to Operate (LTO) Guidelines for Medical Device Establishments
RegistrationVerified

Computed from 22,779 official FDA registration records · data as of 2026-07-10

New registrations by year
2020202120222023202420252026
VerifiedFDA registry · as of 2026-07-10
22,779
Registrations
9,845
Manufacturers
1,918
Importer/Distributors
58
Origin countries
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