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Philippines medical device registration resources

Research FDA Philippines registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Philippines medical device resource.

22,779 registration records11 free resources24/25 requirements covered7 regulations trackedAug 2026 fees reviewed

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Structured regulatory requirements

Explore all 54 source-linked facts

24 of 25 research dimensions currently covered · 24 official sources · latest verification 2026-08-30

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
Core registration regulation
DOH Administrative Order No. 2018 0002 (adopted 26 January 2018) governs documentary requirements for medical device registration and aligns them to the ASEAN Common Submission Dossier Temp…
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…
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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D04

Classification rules

Verified
ASEAN-style risk classes A through D.
Class A, Class B, Class C, Class D
1 maintained scheme
Checked 2026-08-13
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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…
Current market-access surfaces
Initial CMDN applications for Class A devices are filed online through the FDA eServices Portal System (eservices.fda.gov.ph); Class B/C/D devices require CMDR (initial applications for CMD…
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…
4 source-linked facts
Checked 2026-08-25
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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
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…
Retailer LTO scope
LTO is required for establishments selling or offering for sale any medical device including IVDs: retail stores, clinics selling devices, online/social media/TV shopping sellers, medical d…
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
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…
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…
2 source-linked facts
Checked 2026-08-25
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D12

QMS, audit & inspection

Verified
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…
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…
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
Checked 2026-08-29
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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
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…
Renewal filing window
Renewal of CMDR/CMDN is accepted within ninety (90) calendar days prior to the expiry date; late filing incurs the corresponding penalty; a renewal application filed more than one hundred t…
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.
Variation route for CMDR/CPR
Minor and major variations or amendments to CMDR and to CPR of IVDs are applied for through a dedicated CDRRHR service: PDF application by email, Document Tracking Number generated in the F…
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…
Sales promotion restricted to authorized products
Only products with a valid CPR may be applied for sales promotion (per RA 9711 Article V Section 2, as stated in FDA FAQ); sales promo permits are FDA issued services (CDRRHR chart 9 for de…
3 source-linked facts
Checked 2026-08-25
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D25

Submission communications & appeal

Verified
One-time deficiency compliance window
Applications with deficiencies are given a one time compliance period of a maximum of ninety (90) calendar days; non compliance means the application is disapproved; the applicant may re ap…
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;…
3 source-linked facts
Checked 2026-08-25
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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

Registration timeline

Full registration timeline

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

FDA PhilippinesFood and Drug Administration Philippines - Medical Devices
GeneralVerified
AO 2018-0002Administrative Order No. 2018-0002 - Medical Devices Regulation (Full Text PDF)
GeneralVerified
RA 9711Republic Act No. 9711 - FDA Act of 2009
GeneralVerified
CMDR CharterCenter for Medical Device Regulation (CMDR) Registration Guidelines
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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