Explore the medical device requirements currently available for Philippines, organized by topic and linked to official sources.
Which claims, audiences, channels, approvals, and restrictions apply?
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 those in the approved label or packaging or as approved by FDA; no therapeutic or scientific claims may be made without FDA approval.
FDA FAQ page quoting the IRR.
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 are not allowed.
Prescription devices may only be sold with a valid prescription (Sec. V.F).
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 devices), processed in about 7 working days, with campaign duration up to one year, extendable.
Reference: DAO No. 2 s. 1993 as amended by DAO No. 10-02 s. 2010 (per FAQ).
What expires, what is retained periodically, and when must renewal start?
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.
PDF scanned; text recovered by OCR. DTN 20200929100501.
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, CMDR Class B initial and renewals. Exception: transition CMDNs for Class B/C/D under FC 2021-002 were valid two (2) years.
Corrects baseline 'route_dependent' description: the standard term is 5 years; shorter terms are transition/IVD-specific.
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 twenty (120) calendar days after expiration is not accepted and is treated as an initial application, and distribution and sale must automatically stop until the new certificate is approved.
Corrects baseline lapse description.
Renewal and variation are separate application types from initial filings: under FC 2025-007 the Circular covers only initial CMDN applications, with renewal and variation submitted to the FDAC email channel; the 2025 Citizen's Charter defines separate renewal and variation services with their own fees and timelines.
Re-verified from the portal circular itself.
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
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.
Notification-type change obligation.
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.
Effective from 2024-10-01
Change-of-authorization-type procedure.
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 FDA Web Support System, application fee PHP 500 + 10 LRF (brand-name change PHP 2,500 + 25; shelf-life extension PHP 1,000), processed in about 19 working days.
Confirms baseline change-control outcomes (prior approval via variation or new application).
Which clinical or IVD performance evidence or study is required and accepted?
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 technical requirements follow the CSDT template (which structures clinical evidence within the dossier).
Is the product a device, IVD, accessory, software, or borderline product locally?
Medical device means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent and calibrator, software, material or similar article intended by the manufacturer for diagnosis, prevention, monitoring, treatment or alleviation of disease etc., not achieving its principal intended action by pharmacological, immunological or metabolic means.
AO 2018-0002 also defines IVD medical devices separately (Sec. IV(11)).
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 'CPR for IVD Devices/Reagents' service of CDRRHR.
Charter index page (res-ph-cc2025) service 6: 'Issuance of Certificate of Product Registration (CPR) for In Vitro Diagnostic Devices/Reagents (IVD) (Initial Application)'.
Which evidence, local deltas, formats, and signatures are required?
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 contain the technical requirements for initial registration of Class B, C and D in accordance with the CSDT Template; Annex F covers renewal; Annex G covers medical device listing.
2025 CMDR Class B chart requirements start with Executive Summary and CSDT-structured technical sections.
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, notarized declaration); country-of-origin authorization evidence; clear pictures of the actual product; device description (intended use, instruction for use, raw materials list, technical specification); metrology Certificate of Conformity for measuring devices; Declaration of Conformity with product standards; label pictures for all codes; declaration of shelf life.
Chart scanned; text recovered by OCR. Grouping: one application form may cover a device family with conditions (AO Sec. VI).
All documents must be submitted in English; documents in any other foreign language must be accompanied by a notarized English translation for legal documents and an English translation for technical documents; uploads must be searchable PDF of at least 150 dots per inch, named after the requirement, with a table of contents and page numbers.
Chart also notes service covered under RA 3720 Sec. 21 as amended by EO 175 Sec. 13.
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
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 those capacities. Local applicants therefore act through an LTO-licensed establishment.
Confirms baseline market-entry role model.
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 Owner supplies the device under its own name and is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying it.
Notarized Agreement/Letter of Authorization from principal-source/manufacturer is requirement 1 of the CMDN and CMDR checklists.
The Market Authorization Holder (MAH) with a valid CMDN for Class B/C/D devices must apply for CMDR at any time within the CMDN validity period; while the CMDR is being processed the MAH may continue to manufacture, import, export, distribute and/or sell the product, presenting the CMDN and proof of payment at the point of entry or in bidding.
Effective from 2024-10-01
MAH defined in RA 9711 IRR terms as the owner of the FDA authorization.
Which establishment licences, importer permissions, and distribution controls apply?
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; with a valid CMDN, the issued CMDN and proof of payment for the CMDR application serve that role while the CMDR is processed.
Pending application = application with proof of payment and doc track number.
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 Operate from FDA before engaging in manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products.
AO 2020-0017 itself (dmas.doh.gov.ph) could not be opened; quoted as cited in FC 2021-0021.
All licensed retailers are subject to routine or spot-check inspection during operating hours by authorized FDA personnel; inspections verify business registration, qualified-person credentials, SOPs reflecting good storage and distribution practices, valid LTO, copies of CMDN/CMDR of devices sold, and a risk management plan.
Qualified-person duties include observance of good storage and distribution practices.
All retailers of medical devices may only sell or offer for sale devices with the appropriate FDA authorization (CMDR or CMDN) as applicable; prescription devices may only be sold against a valid prescription (ophthalmic devices dispensed by a registered optometrist).
Manufacturers/traders/distributors selling directly to the public need a minor variation (additional activity) of their LTO.
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 device vending machine operators, optical shops, and drug outlets that also sell devices; grocery stores, supermarkets, convenience stores and kiosks are exempt from the LTO but remain liable if they sell unregistered/unnotified devices.
Existing retailers had 2 years from circular effectivity to comply (transitory provision).
What regulator fee applies to this class, route, event, and date?
A Legal Research Fee (LRF) of 1% of the fee is added to FDA charges, pursuant to FDA Circular 2011-003 (RA 3870 as amended by PD 200 and PD 1856); all quoted CDRRHR fees are inclusive of this LRF where shown.
Distinct legal rule expressed as fact; per-event amounts are recorded in typedFindings.
Which label and IFU elements, languages, symbols, and translation controls apply?
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 must be reflected; additional product claims on the label need supporting studies; CE marking on labels requires a valid supporting certificate; instruction for use must be detailed enough to guide users.
English language requirement for documents applies (Chart 10 general remarks).
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 distributor); (c) the CMDN or CMDR number.
Charter 2025 note: requirements shall be superseded upon approval of the AO on labeling requirements of medical devices (still pending).
Which current law, regulation, guidance, and transition provisions apply?
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 2024; from 1 October 2024 marketing without CMDN/CMDR or a pending application (with proof of payment and document tracking number) is prohibited.
Effective from 2024-10-01
Modifies/repeals Sec. V items A-F of FC 2021-002-C.
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 Circular 2011-003 (RA 3870 as amended).
LRF detail quoted in FC 2021-002: 'The fee for CMDN shall be P3,000.00 and an additional 1% thereof for the Legal Research Fee (LRF)'.
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 Template (CSDT) under the ASEAN Medical Device Directive; it repeals FDA Memorandum Circular No. 2014-005.
Issued pursuant to RA 9711 and its IRR.
Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?
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, documented and reported through the supplier/distributor chain, ensure all products sold carry FDA authorization, and keep updated on AO 2018-0002 implementation.
A risk management plan is among documents verified at inspection.
Which current form, portal, account, and submission package must be used?
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 variation applications, which are submitted to the Food and Drug Action Center (FDAC) by email at fdac.letters@fda.gov.ph; the old ePortal CMDN application is deactivated upon effectivity.
Account and password creation is no longer required to access the system (Advisory 2025-0189).
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 applications transmitted via email to FDA (FDAC) and processed through the FDA Web Support System which issues the Order of Payment and Document Tracking Number.
Effective from 2025-03-10
Advisory 2025-0189: 'required to apply for Certificate of Medical Device Registration (CMDR) for Class B, C and D' via email.
Which QMS, audit, inspection, and certificate scope is accepted or required?
Licensed device establishments are subject to FDA inspection: retailers face routine or spot-check inspections verifying storage/distribution SOPs, qualified-person credentials and product authorizations; failure to comply with licensing conditions is ground for LTO disapproval under AO 2020-0017 and AO 2014-029 (FDA FAQ).
Grounds for LTO disapproval per AO 2020-0017 quoted on FDA FAQs page.
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 and facilities, a Quality Systems Certificate of approval, or a compliance certificate for ISO 13485; the certificate must be valid, indicate the product applied for in its scope, and be accompanied by a notarized declaration; multi-site/toll manufacturers must identify the product source.
Identical requirement appears in Chart 10 (CMDR Class B).
Which recall, FSCA, notice, and authority-coordination duties apply?
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 unregistered, counterfeit, injurious, unsafe or dangerous.
FSCA reporting channel under PMAS (AO 2025-0030) not yet opened to provision level.
Which registration, notification, listing, reliance, or conformity route applies?
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, issued as Certificate of Product Registration).
CMDR/CPR terminology per 2025 Citizen's Charter and Advisory 2025-0189.
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/or user must apply for a Certificate of Medical Device Listing (CMDL).
CMDL remains a CDRRHR service (2025 Citizen's Charter, service 4).
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 CMDN for B/C/D are no longer accepted) and IVDs follow the separate CPR-for-IVD route; unregistered products may not be marketed.
Effective from 2025-03-10
ePortal CMDN application deactivated from 10 March 2025; pilot-era B/C/D eServices applications still processed.
RA 3720 as amended by RA 9711 prohibits the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertisement or sponsorship of any health product which, although requiring registration, is not registered with the FDA.
Penalties under RA 9711 and its IRR.
Which foreign decisions or evidence can be reused, with what effect and conditions?
Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.
No linked record is currently maintained. This does not establish that a pathway is unavailable.
Prior approval / evidence record
ASEAN Medical Device Directive (AMDD) harmonisation
The AMDD gives the ten member states one device definition, one set of classification rules, one set of essential principles and one dossier structure, the Common Submission Dossier Template. It is not a reliance route. The ACCSQ Medical Device Product Working Group states in terms that the Directive is "not intended to confer mutual recognition" and that each member state retains the sovereign right to make its own registration decisions, so a registration in one ASEAN market authorises nothing in another and shortens no national review period.
None — the saving is in dossier preparation, since one CSDT core can be reused across member states with national addenda
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
EU CE Mark
Yes
Supports the Certificate of Free Sale and the CSDT technical evidence, but the Philippine FDA publishes no shorter period for it
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
Philippine registration requirements are aligned to the ASEAN Common Submission Dossier Template (CSDT) per the ASEAN Medical Device Directive; CSDT is a dossier format, not a mutual recognition of approvals - each application is still filed and decided locally.
Regulatory reference
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 requirements, valid and accompanied by a notarized declaration from the legal manufacturer or product owner.
Chart scanned; text recovered by OCR.
Prior approval / evidence record
FDA 510(k)
Yes
Supports the Certificate of Free Sale and the CSDT technical evidence, but the Philippine FDA publishes no shorter period for it
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
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 technical dossier submitted to the reference NRA; technical documents are not technically reviewed except labeling; the reference-NRA CPR is verified; turnaround 30 working days from receipt of proof of payment.
Implements WHO good reliance practices under RA 9711 and RA 11032.
Prior approval / evidence record
class-d
Class D
highest
Full Registration
180
180
days
official-verified
FDA Philippines AO 2018-0002 — statutory evaluation clocks
https://elibrary.judiciary.gov.ph/thebookshelf/showdocs/10/89924
2026-08-25
9
18
months
6
10
months
Yes
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-b
Class B
medium
Registration
80
80
working-days
official-verified
FDA Philippines Citizen’s Charter 2025 — CDRRHR total processing times
https://www.fda.gov.ph/citizen-charter-cdrrhr-2025/
2026-08-25
4
9
months
3
5
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
For Class A notification of imported devices, the 2025 Citizen's Charter checklist requires evidence attesting to safety and effectiveness issued in the country of origin, which may be a product notification, certificate of product registration or equivalent document issued by the manufacturer (self-declaration), the regulatory agency or an accredited notified body. An NMPA Class I filing record or a Class II/III registration certificate for a China-made device satisfies this documentary requirement; there is no abridged review linked to it.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
philippines
Class A imported devices (Certificate of Medical Device Notification); NMPA Class I filing or Class II/III certificate serves as country-of-origin evidence
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Effective from 2025-09-01
Source passage: Evidence attesting to safety and effectiveness issued in the country of origin: product notification, certificate of product registration, or equivalent document issued by the manufacturer (self-declaration), regulatory agency or accredited notified body
Regulatory reference
FDA Circular No. 2022-008 limits abridged processing to Class B/C/D devices with product approval issued by the national regulatory authority of an ASEAN member country under the AMDD-CSDT requirements, and expressly excludes devices whose CPR is based on abridged approval in countries outside ASEAN. China is not an ASEAN member, so an NMPA registration certificate does not qualify a device for abridged processing; such applications undergo standard CDRRHR technical review under AO 2018-0002.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
philippines
Class B/C/D medical devices (abridged processing); NMPA approvals not eligible; IVDs and refurbished devices excluded from the circular altogether
No Reliance Route
none
Product Marketing
Yes
Yes
Source passage: This Circular shall apply to Class B, C and D medical devices that are covered under AO No. 2018-0002, with product approval issued by the NRA of any ASEAN member country under the AMDD-CSDT requirements ... This issuance shall not cover medical devices with issued Certificate of Product Registration (CPR) based on abridged approval in other countries outside the ASEAN. ... Reference national regulatory authority (NRA) refers to the FDA counterpart regulatory authority of any ASEAN member country which approves medical devices based on the AMDD-CSDT requirements.
Prior approval / evidence record
ASEAN member-state registration
No
There is no ASEAN mutual recognition agreement for device registration — the AMDD harmonises the dossier, not the decision
None
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-c
Class C
high
Registration
180
180
days
official-verified
FDA Philippines AO 2018-0002 — statutory evaluation clocks
https://elibrary.judiciary.gov.ph/thebookshelf/showdocs/10/89924
2026-08-25
6
12
months
4
7
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
Class A notification requires evidence attesting to safety and effectiveness issued in the country of origin: product notification, certificate of product registration, or equivalent document issued by the manufacturer (self-declaration), regulatory agency or accredited notified body; must be valid, with notarized declaration; authenticated or apostilled documents accepted per checklist conditions.
For locally manufactured products the valid LTO of the manufacturer is submitted instead.
What review, validation, and applicant stop-clock rules apply?
An Order of Payment issued by FDA is valid only for a limited window: 5 working days for CMDN initial applications, 15 working days for CMDR Class B initial applications, and 24 hours for CMDN/CMDR renewal applications; payment must be made within that window.
Stop-clock style rule not expressible in the timelines dataset.
Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?
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 attention; applicants include device manufacturers/importers, hospitals, attending physicians and DOH; requirements include letter of intent, physician profile, country-of-origin CPR (or local manufacturer LTO) and technical description; fee PHP 500 + 10 LRF; about 6 working days.
Basis: RA 9711 and RA 3720 (chart header).
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
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; one motion for reconsideration may be filed and suspends the running of the period.
Only one motion for reconsideration is allowed.
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 does not stay the decision unless the Secretary issues a stay order.
Appeal bond requirement applies.
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-apply within sixty (60) calendar days after disapproval, with corresponding fee; unclaimed disapproved applications are destroyed after 90 calendar days.
2025 CMDR chart timeline applies to applications 'complete and correct with no Notice of Deficiencies issued'.
Which UDI, device listing, database, and traceability duties apply?
The list of all approved CMDRs and CMDNs is posted on the FDA website, giving a public registry of authorized devices.
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 submitted.
Partial traceability baseline pending a UDI system.
What is reportable, by whom, where, in what format, and by what deadline?
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, Radiation Health and Research; the qualified person of the establishment is responsible for ensuring adverse events are handled, documented and reported.
Draft PMAS circular would channel reports to cdrrhr-prsdd@fda.gov.ph with AE/FSCA report forms (Annex A/B).
philippines:medical-device
philippines
ASEAN-style risk classes A through D.
a
Class A
low
b
Class B
medium
c
Class C
high
d
Class D
highest
FDA Philippines
official-source-verified
Philippines FDA Circular 2021-017
https://www.fda.gov.ph/wp-content/uploads/2021/08/FDA-Circular-2021-017.pdf
2026-08-13
Philippines
philippines
PH
🇵🇭
Food and Drug Administration
FDA Philippines
asia-pacific
2
4-class (A, B, C, D)
class-a
Class A
low
Notification
23
23
working-days
official-verified
FDA Philippines Citizen’s Charter 2025 — CDRRHR total processing times
https://www.fda.gov.ph/citizen-charter-cdrrhr-2025/
2026-08-25
2
4
months
No
No
No
class-b
Class B
medium
Registration
80
80
working-days
official-verified
FDA Philippines Citizen’s Charter 2025 — CDRRHR total processing times
https://www.fda.gov.ph/citizen-charter-cdrrhr-2025/
2026-08-25
4
9
months
3
5
months
No
No
Yes
class-c
Class C
high
Registration
180
180
days
official-verified
FDA Philippines AO 2018-0002 — statutory evaluation clocks
https://elibrary.judiciary.gov.ph/thebookshelf/showdocs/10/89924
2026-08-25
6
12
months
4
7
months
No
No
Yes
class-d
Class D
highest
Full Registration
180
180
days
official-verified
FDA Philippines AO 2018-0002 — statutory evaluation clocks
https://elibrary.judiciary.gov.ph/thebookshelf/showdocs/10/89924
2026-08-25
9
18
months
6
10
months
Yes
No
Yes
ASEAN Medical Device Directive (AMDD) harmonisation
The AMDD gives the ten member states one device definition, one set of classification rules, one set of essential principles and one dossier structure, the Common Submission Dossier Template. It is not a reliance route. The ACCSQ Medical Device Product Working Group states in terms that the Directive is "not intended to confer mutual recognition" and that each member state retains the sovereign right to make its own registration decisions, so a registration in one ASEAN market authorises nothing in another and shortens no national review period.
None — the saving is in dossier preparation, since one CSDT core can be reused across member states with national addenda
FDA 510(k)
Yes
Supports the Certificate of Free Sale and the CSDT technical evidence, but the Philippine FDA publishes no shorter period for it
None published
EU CE Mark
Yes
Supports the Certificate of Free Sale and the CSDT technical evidence, but the Philippine FDA publishes no shorter period for it
None published
ASEAN member-state registration
No
There is no ASEAN mutual recognition agreement for device registration — the AMDD harmonises the dossier, not the decision
None
Yes
Philippines Local Agent
No
Not accepted but ISO 13485 required
5 years
official-verified
FDA Philippines Citizen’s Charter 2025 — CDRRHR total processing times
https://www.fda.gov.ph/citizen-charter-cdrrhr-2025/
2026-08-25
FDA Philippines AO 2018-0002 — statutory evaluation clocks
https://elibrary.judiciary.gov.ph/thebookshelf/showdocs/10/89924
2026-08-25
ACCSQ Medical Device Product Working Group — Implementing the ASEAN Medical Device Directive: "Not intended to confer mutual recognition; each member state retains sovereign right for registration decisions"
https://www.ahwp.info/sites/default/files/6%20Implementing%20the%20ASEAN%20Medical%20Device%20Directive%201.0.pdf
2026-08-30
2026-08-30
2026-08-30
default
planning-template
Maintained planning steps and estimates, not verified regulator deadlines.
1
Pre-Submission Preparation
Gather technical documentation, quality management system (QMS) records, and clinical data required by FDA Philippines. Appoint a Philippines Local Agent.
1-3 months
📋
2
Application Submission
Submit complete registration dossier to FDA Philippines including device description, risk analysis, and testing reports.
1-2 weeks
📤
3
Administrative Review
FDA Philippines reviews application for completeness. May request additional documents or clarifications.
2-4 weeks
🔍
4
Technical Evaluation
In-depth technical assessment of device safety and performance. FDA Philippines may issue questions.
23 working days
⚙️
5
Registration Approval
Upon successful review, FDA Philippines issues Philippines market authorization certificate.
1-2 weeks
✅
philippines
Philippines
PH
FDA Philippines
5050
7575
PHP
Yes
3030
7575
PHP
Yes
initial-cmdn-class-a
Initial Certificate of Medical Device Notification - Class A
PHP
7575
PHP 7,575
Per product
PHP 7,500 fee plus 1% Legal Research Fund charge; five-year validity.
exact-current
official-verified
https://www.fda.gov.ph/wp-content/uploads/2024/04/6.-Center-for-Device-Regulation-Radiation-Health-and-Research-CDRRHR-External-Services.pdf
FDA Philippines CDRRHR Citizen’s Charter: medical-device fees under the pre-AO 2024-0016 schedule
2026-08-25
initial-cmdr-class-b
Initial Certificate of Medical Device Registration - Class B
PHP
7575
PHP 7,575
Per product
PHP 7,500 fee plus 1% Legal Research Fund charge; five-year validity.
exact-current
official-verified
https://www.fda.gov.ph/wp-content/uploads/2024/04/6.-Center-for-Device-Regulation-Radiation-Health-and-Research-CDRRHR-External-Services.pdf
FDA Philippines CDRRHR Citizen’s Charter: medical-device fees under the pre-AO 2024-0016 schedule
2026-08-25
initial-cmdr-class-c-d
Initial Certificate of Medical Device Registration - Class C/D
PHP
7575
PHP 7,575
Per product
PHP 7,500 fee plus 1% Legal Research Fund charge; five-year validity.
exact-current
official-verified
https://www.fda.gov.ph/wp-content/uploads/2024/04/6.-Center-for-Device-Regulation-Radiation-Health-and-Research-CDRRHR-External-Services.pdf
FDA Philippines CDRRHR Citizen’s Charter: medical-device fees under the pre-AO 2024-0016 schedule
2026-08-25
temporary-cmdn-class-b-c-d
Initial notification - Class B/C/D not yet included in the registrable-device list
PHP
3030
PHP 3,030
Per product
PHP 3,000 fee plus 1% Legal Research Fund charge; two-year validity for this temporary notification route.
exact-current
official-verified
https://www.fda.gov.ph/wp-content/uploads/2024/04/6.-Center-for-Device-Regulation-Radiation-Health-and-Research-CDRRHR-External-Services.pdf
FDA Philippines CDRRHR Citizen’s Charter: medical-device fees under the pre-AO 2024-0016 schedule
2026-08-25
renewal-cmdn-cmdr-class-a-d
CMDN/CMDR renewal - Class A/B/C/D
PHP
5050
PHP 5,050
Per product renewal
PHP 5,000 fee plus 1% Legal Research Fund charge; five-year validity. Late-renewal surcharge escalates monthly (PHP 500/1,000/1,500/2,000) plus a PHP 10,000 penalty.
exact-current
official-verified
https://www.fda.gov.ph/wp-content/uploads/2024/04/6.-Center-for-Device-Regulation-Radiation-Health-and-Research-CDRRHR-External-Services.pdf
FDA Philippines CDRRHR Citizen’s Charter: medical-device fees under the pre-AO 2024-0016 schedule
2026-08-25
variation-application
Variation of CMDR / CPR-IVD - application
PHP
510
PHP 510
Per application
PHP 500 fee plus PHP 10 Legal Research Fund charge.
exact-current
official-verified
https://www.fda.gov.ph/wp-content/uploads/2025/09/8.-Application-for-Variation-of-Certificate-of-Product-Registration-CPR-of-In-vitro-Diagnostic-Devices-Reagents-IVD-and-Certificate-ofMedical-Device-Registration-CMDR.pdf
FDA Philippines Citizen’s Charter 2025, Chart 8: variation of CMDR / CPR-IVD
2026-08-25
variation-brand-name-change
Variation - change in brand name
PHP
2525
PHP 2,525
Per application
PHP 2,500 fee plus 1% Legal Research Fund charge.
exact-current
official-verified
https://www.fda.gov.ph/wp-content/uploads/2025/09/8.-Application-for-Variation-of-Certificate-of-Product-Registration-CPR-of-In-vitro-Diagnostic-Devices-Reagents-IVD-and-Certificate-ofMedical-Device-Registration-CMDR.pdf
FDA Philippines Citizen’s Charter 2025, Chart 8: variation of CMDR / CPR-IVD
2026-08-25
variation-shelf-life-extension
Variation - shelf-life extension
PHP
1010
PHP 1,010
Per application
PHP 1,000 fee plus 1% Legal Research Fund charge.
exact-current
official-verified
https://www.fda.gov.ph/wp-content/uploads/2025/09/8.-Application-for-Variation-of-Certificate-of-Product-Registration-CPR-of-In-vitro-Diagnostic-Devices-Reagents-IVD-and-Certificate-ofMedical-Device-Registration-CMDR.pdf
FDA Philippines Citizen’s Charter 2025, Chart 8: variation of CMDR / CPR-IVD
2026-08-25
compassionate-special-permit
Compassionate Special Permit - device
PHP
510
PHP 510
Per application
PHP 500 fee plus PHP 10 Legal Research Fund charge.
exact-current
official-verified
https://www.fda.gov.ph/wp-content/uploads/2025/09/19.-Issuance-of-Compassionate-Special-Permit-CSP.pdf
FDA Philippines Citizen’s Charter 2025, Chart 19: Compassionate Special Permit
2026-08-25
cpr-ivd-initial-1-year
CPR for IVD initial application - 1-year validity
PHP
1515
PHP 1,515
Per product
PHP 1,500 fee plus 1% Legal Research Fund charge; excludes performance-evaluation test cost.
exact-current
official-verified
https://www.fda.gov.ph/wp-content/uploads/2025/09/6.-Issuance-of-Certificate-of-Product-Registration-CPR-for-In-Vitro-Diagnostic-Devices-Reagents-IVD-Initial-Application.pdf
FDA Philippines Citizen’s Charter 2025, Chart 6: CPR for IVD initial application
2026-08-25
cpr-ivd-initial-hcg-6-year
CPR for IVD initial application - hCG products, 6-year validity
PHP
2525
PHP 2,525
Per product
PHP 2,500 fee plus 1% Legal Research Fund charge; hCG products requiring performance evaluation add PHP 1,000.
exact-current
official-verified
https://www.fda.gov.ph/wp-content/uploads/2025/09/6.-Issuance-of-Certificate-of-Product-Registration-CPR-for-In-Vitro-Diagnostic-Devices-Reagents-IVD-Initial-Application.pdf
FDA Philippines Citizen’s Charter 2025, Chart 6: CPR for IVD initial application
2026-08-25
lto-retailer-initial
Licence to Operate - medical-device retailer, initial
PHP
2000
PHP 2,000
Per licence, valid 2 years
Plus 1% Legal Research Fund charge (FDA Circular 2021-0021 Sec. V.D, mirroring AO 50 s. 2001).
exact-current
official-verified
https://www.fda.gov.ph/fda-circular-no-2021-0021-guidelines-on-the-licensing-of-retailers-of-medical-devices-in-the-philippines/
FDA Philippines Circular 2021-0021: licensing of medical-device retailers
2021-01-01
2026-08-25
lto-retailer-renewal
Licence to Operate - medical-device retailer, renewal
PHP
3000
PHP 3,000
Per renewal, valid 3 years
Plus 1% Legal Research Fund charge.
exact-current
official-verified
https://www.fda.gov.ph/fda-circular-no-2021-0021-guidelines-on-the-licensing-of-retailers-of-medical-devices-in-the-philippines/
FDA Philippines Circular 2021-0021: licensing of medical-device retailers
2021-01-01
2026-08-25
lto-retailer-variation
Licence to Operate - variation
PHP
500
PHP 500
Per variation
Plus 1% Legal Research Fund charge.
exact-current
official-verified
https://www.fda.gov.ph/fda-circular-no-2021-0021-guidelines-on-the-licensing-of-retailers-of-medical-devices-in-the-philippines/
FDA Philippines Circular 2021-0021: licensing of medical-device retailers
2021-01-01
2026-08-25
2026-08-25
official-verified
FDA Philippines CDRRHR Citizen’s Charter: medical-device fees under the pre-AO 2024-0016 schedule
https://www.fda.gov.ph/wp-content/uploads/2024/04/6.-Center-for-Device-Regulation-Radiation-Health-and-Research-CDRRHR-External-Services.pdf
2026-08-25
DOH Department Circular 2026-0329: further 120-working-day AO 2024-0016 suspension
https://www.fda.gov.ph/wp-content/uploads/2026/06/Department-Circular-No.2026-0329.pdf
2026-06-09
2026-08-25
DOH Department Circular 2025-0382: extension of AO 2024-0016 suspension
https://www.fda.gov.ph/wp-content/uploads/2025/09/Department-Circular-No.-2025-0382.pdf
2025-09-05
2026-08-25
2026 stakeholder consultation on amendment of AO 2024-0016
https://www.fda.gov.ph/announcement-stakeholder-survey-for-participation-in-the-public-consultation-on-the-amendment-of-administrative-order-no-2024-0016/
2026-03-30
2026-08-25
Philippines FDA AO 2024-0016 fee schedule
https://www.fda.gov.ph/administrative-order-implementing-guidelines-on-the-new-schedule-of-fees-and-charges-of-the-food-and-drug-administration/
2025-01-12
2026-08-25
FDA Philippines Citizen’s Charter 2025, Chart 8: variation of CMDR / CPR-IVD
https://www.fda.gov.ph/wp-content/uploads/2025/09/8.-Application-for-Variation-of-Certificate-of-Product-Registration-CPR-of-In-vitro-Diagnostic-Devices-Reagents-IVD-and-Certificate-ofMedical-Device-Registration-CMDR.pdf
2026-08-25
FDA Philippines Citizen’s Charter 2025, Chart 19: Compassionate Special Permit
https://www.fda.gov.ph/wp-content/uploads/2025/09/19.-Issuance-of-Compassionate-Special-Permit-CSP.pdf
2026-08-25
FDA Philippines Citizen’s Charter 2025, Chart 6: CPR for IVD initial application
https://www.fda.gov.ph/wp-content/uploads/2025/09/6.-Issuance-of-Certificate-of-Product-Registration-CPR-for-In-Vitro-Diagnostic-Devices-Reagents-IVD-Initial-Application.pdf
2026-08-25
FDA Philippines Circular 2021-0021: licensing of medical-device retailers
https://www.fda.gov.ph/fda-circular-no-2021-0021-guidelines-on-the-licensing-of-retailers-of-medical-devices-in-the-philippines/
2021-01-01
2026-08-25
2026-08-25
exact-current
Yes
philippines
Philippines
low
fda-electrical-emc-evidence
FDA electrical/EMC evidence
Medical Electrical Safety
Included In Medical Registration
Finished Device
CMDN/CMDR dossiers: Declaration of Conformity with product standards listing the standards used in design, development, manufacture and testing (recognized standards are PNS, ISO, IEC and equivalents per AO 2018-0002 Sec. IV(19)); imported devices need a government-issued manufacturer status/quality certificate, Quality Systems Certificate or ISO 13485 compliance certificate with notarized declaration.
unresolved
ntc-type-acceptance
NTC Type Acceptance
Radio Spectrum
Mandatory If Feature
Radio Communications Equipment
candidate
ntc-type-approval
NTC Type Approval
Telecom Network Attachment
Mandatory If Feature
Customer Premises Equipment
candidate
ntc-general-equipment-certificate
NTC General Equipment Certificate
Radio Spectrum
Mandatory If Feature
Customer Premises Equipment With Integrated Radio
candidate
bps-ps-icc-mark
BPS PS/ICC mark
General Electrical Components
Mandatory If Feature
Mandatory List Product Or Component
unresolved
fda-cdrrhr-facility-lto
FDA CDRRHR facility LTO
Ionizing Radiation
Mandatory For Use Site
Radiation Facility
candidate
metrology-certificate-of-conformity
Metrology Certificate of Conformity
Legal Metrology
Mandatory If Feature
Device With Measuring Function
FDA Philippines CMDN chart 20 requirement 6: devices with measuring functions (e.g. thermometers, weighing scales) require a Certificate of Conformity issued by the government metrology agency (or its equivalent) on the aspect of manufacture relating to metrology, submitted at CMDN application.
reviewed
NTC
type approval, type acceptance and GEC forms
https://ntc.gov.ph/downloadable-forms-2/
FDA Philippines
radiation-facility licensing and registration
https://www.fda.gov.ph/administrative-order-no-2020-0035-rules-and-regulations-on-the-licensing-and-registration-of-radiation-facilities-involved-in-the-use-of-radiation-devices-and-issuance-of-other-related-authorizati/
FDA Philippines
CMDN initial application charts metrology certificate and standards declaration
https://www.fda.gov.ph/wp-content/uploads/2025/09/20.-Issuance-of-Certificate-of-Medical-Device-Notification-Initial-Application.pdf
