FDA Philippines · structured requirements

🇵🇭 Philippines IVD regulatory data

Explore the IVD requirements currently available for Philippines, organized by topic and linked to official sources.

2 facts1 dimensions2 official sourceslatest verification 2026-09-15

Changes after registration

Common questions about changing a registered IVD in Philippines. Each question separates published rules from details still awaiting verification.

Does changing a device brand name or logo require an update? →Specific rules awaiting verification
How do I update a manufacturer's name without changing the legal entity? →Specific rules awaiting verification
What changes when the manufacturer's office address changes? →Specific rules awaiting verification
Does a catalogue or reference code change affect registration or UDI? →Specific rules awaiting verification
Can a registration transfer to a different legal entity? →Specific rules awaiting verification
Can several changes be filed together? →Specific rules awaiting verification

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

Compare countries

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.

Philippines approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Philippines (9 records)

PhilippinesASEAN

Prior approval / evidence record

ASEAN Medical Device Directive (AMDD) harmonisation

Name: ASEAN Medical Device Directive (AMDD) harmonisation
Description: 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.
Timeline Reduction: None — the saving is in dossier preparation, since one CSDT core can be reused across member states with national addenda
Eligibility: Any device filed in an ASEAN member state that has transposed the AMDD into national law

FDA Philippines Citizen’s Charter 2025 — CDRRHR total processing times FDA Philippines AO 2018-0002 — statutory evaluation clocks 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"

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

PhilippinesEU conformity assessment

Prior approval / evidence record

EU CE Mark

Authority: EU CE Mark
Accepted: Yes
Benefit: Supports the Certificate of Free Sale and the CSDT technical evidence, but the Philippine FDA publishes no shorter period for it
Timeline Savings: None published

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

PhilippinesUS FDA

Prior approval / evidence record

FDA 510(k)

Authority: FDA 510(k)
Accepted: Yes
Benefit: Supports the Certificate of Free Sale and the CSDT technical evidence, but the Philippine FDA publishes no shorter period for it
Timeline Savings: None published

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

PhilippinesUS FDA · EU conformity assessment

Prior approval / evidence record

Class D

class-d

Class Name

Class D

Risk Level

highest

Pathway

Full Registration

Official Timeline

Min: 180
Max: 180
Unit: days

Verification Status

official-verified

Official Source

Title: FDA Philippines AO 2018-0002 — statutory evaluation clocks
Url: https://elibrary.judiciary.gov.ph/thebookshelf/showdocs/10/89924
Accessed Date: 2026-08-25

Realistic Timeline

Min: 9
Max: 18
Unit: months

With Prior Approval

Min: 6
Max: 10
Unit: months

Prior Approval Benefits

FDA PMA
EU CE Mark Class III

Notes

AO 2018-0002 Sec. VII.A.4: initial applications evaluated within 180 days upon filing
Abridged processing (ASEAN NRA-approved): 30 working days (FDA Circular 2022-008)
Clinical evidence required

Clinical Trial Required

Yes

Local Testing Required

Gmp Required

Yes

FDA Philippines AO 2018-0002 — statutory evaluation clocks

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

PhilippinesUS FDA · EU conformity assessment · ASEAN

Prior approval / evidence record

Class B

class-b

Class Name

Class B

Risk Level

medium

Pathway

Registration

Official Timeline

Min: 80
Max: 80
Unit: working-days

Verification Status

official-verified

Official Source

Title: FDA Philippines Citizen’s Charter 2025 — CDRRHR total processing times
Url: https://www.fda.gov.ph/citizen-charter-cdrrhr-2025/
Accessed Date: 2026-08-25

Realistic Timeline

Min: 4
Max: 9
Unit: months

With Prior Approval

Min: 3
Max: 5
Unit: months

Prior Approval Benefits

FDA
EU CE Mark
ASEAN MRA

Notes

2025 Citizen's Charter: CMDR Class B initial registration decided in 80 total working days for complete applications
Abridged processing (ASEAN NRA-approved Class B/C/D): 30 working days from receipt of proof of payment (FDA Circular 2022-008)
ASEAN harmonization applies

Clinical Trial Required

Local Testing Required

Gmp Required

Yes

FDA Philippines Citizen’s Charter 2025 — CDRRHR total processing times

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

PhilippinesNMPA

Prior approval / evidence record

China NMPA approval: origin evidence only

reliance.china-nmpa-origin-evidence

Pending verification

Statement: 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.
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: China NMPA medical device registration certificate (Class II/III) or Class I filing record
Target Jurisdiction Id: philippines
China Classes In Scope: Class A imported devices (Certificate of Medical Device Notification); NMPA Class I filing or Class II/III certificate serves as country-of-origin evidence
Edge Type: Origin Country Evidence
Market Access Strength: Evidence Only
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Document must be valid and accompanied by a notarised declaration
Authentication or apostille required per the checklist timing conditions
Applies to imported Class A devices only; Class B-D imports require ASEAN-NRA approval evidence for the abridged route (held)
Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

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

PhilippinesNMPA

Regulatory reference

China NMPA approval: not reference

reliance.china-nmpa-not-reference

Pending verification

Statement: 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.
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: China NMPA medical device registration certificate (Class II/III) or Class I filing record
Target Jurisdiction Id: philippines
China Classes In Scope: Class B/C/D medical devices (abridged processing); NMPA approvals not eligible; IVDs and refurbished devices excluded from the circular altogether
Edge Type: No Reliance Route
Market Access Strength: none
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Reference NRA defined as the FDA counterpart of any ASEAN member country approving devices on AMDD-CSDT requirements
Same medical device as approved by the reference NRA, attested in a notarised application form
Technical documents must be the latest set filed with the reference NRA; only labelling is technically reviewed
30 working days turnaround from proof of payment
FDA may forego abridged processing on negative reports or conflicting ASEAN assessments
Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

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.

PhilippinesASEAN

Prior approval / evidence record

ASEAN member-state registration

Authority: ASEAN member-state registration
Accepted: No
Benefit: There is no ASEAN mutual recognition agreement for device registration — the AMDD harmonises the dossier, not the decision
Timeline Savings: None

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

PhilippinesUS FDA · EU conformity assessment · ASEAN

Prior approval / evidence record

Class C

class-c

Class Name

Class C

Risk Level

high

Pathway

Registration

Official Timeline

Min: 180
Max: 180
Unit: days

Verification Status

official-verified

Official Source

Title: FDA Philippines AO 2018-0002 — statutory evaluation clocks
Url: https://elibrary.judiciary.gov.ph/thebookshelf/showdocs/10/89924
Accessed Date: 2026-08-25

Realistic Timeline

Min: 6
Max: 12
Unit: months

With Prior Approval

Min: 4
Max: 7
Unit: months

Prior Approval Benefits

FDA
EU CE Mark
ASEAN MRA

Notes

AO 2018-0002 Sec. VII.A.4: initial applications evaluated within 180 days upon filing
Abridged processing (ASEAN NRA-approved): 30 working days (FDA Circular 2022-008)
Clinical data may be required

Clinical Trial Required

Local Testing Required

Gmp Required

Yes

FDA Philippines AO 2018-0002 — statutory evaluation clocks

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Related structured datasets

Classification systems · 1 record

Open ASEAN-style risk classes A through D. →

philippines:medical-device

Jurisdiction Id

philippines

Domains

medical-device
ivd

Name

ASEAN-style risk classes A through D.

Classes

Id
a
Label
Class A
Normalized Risk Level
low
Id
b
Label
Class B
Normalized Risk Level
medium
Id
c
Label
Class C
Normalized Risk Level
high
Id
d
Label
Class D
Normalized Risk Level
highest

Regulator

FDA Philippines

Official Domains

fda.gov.ph

Source Status

official-source-verified

Source Title

Philippines FDA Circular 2021-017

Source Url

https://www.fda.gov.ph/wp-content/uploads/2021/08/FDA-Circular-2021-017.pdf

Verified On

2026-08-13

Source Supports

class-axis
classification-rules

Notes

AO 2018-0002 Sec. V(1)-(3) and FDA Circular 2021-017 Sec. III: classification follows the ACCSQ-MDPWG / AMDD rule-based system (A low, B low-moderate, C moderate-high, D high); applicant classifies per CDRRHR-issued lists (FC 2021-017 Annex A for Class A; FC 2020-001-A registrable list) or, if not listed, by intended use under AMDD rules; CDRRHR verifies and may reclassify; classification changes if indicated use, claim or duration of use changes.
Route coupling: Class A -> notification (CMDN); Classes B, C, D -> registration (CMDR/CPR); IVDs are excluded from this scheme and follow a separate CPR-IVD route.

Registration pathways, prior approvals and planning · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Philippines registration →

Country

Philippines

Jurisdiction Id

philippines

Country Code

Flag

🇵🇭

Regulator

Food and Drug Administration

Regulator Abbrev

FDA Philippines

Region

asia-pacific

Tier

Risk Classification

4-class (A, B, C, D)

Classes

Id
class-a
Class Name
Class A
Risk Level
low
Pathway
Notification
Official Timeline
Min
23
Max
23
Unit
working-days
Verification Status
official-verified
Official Source
Title
FDA Philippines Citizen’s Charter 2025 — CDRRHR total processing times
Url
https://www.fda.gov.ph/citizen-charter-cdrrhr-2025/
Accessed Date
2026-08-25
Realistic Timeline
Min
2
Max
4
Unit
months
Notes
2025 Citizen's Charter: CMDN initial notification decided in 23 total working days for complete applications with no Notice of Deficiencies
Notification-based
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No
Id
class-b
Class Name
Class B
Risk Level
medium
Pathway
Registration
Official Timeline
Min
80
Max
80
Unit
working-days
Verification Status
official-verified
Official Source
Title
FDA Philippines Citizen’s Charter 2025 — CDRRHR total processing times
Url
https://www.fda.gov.ph/citizen-charter-cdrrhr-2025/
Accessed Date
2026-08-25
Realistic Timeline
Min
4
Max
9
Unit
months
With Prior Approval
Min
3
Max
5
Unit
months
Prior Approval Benefits
FDA
EU CE Mark
ASEAN MRA
Notes
2025 Citizen's Charter: CMDR Class B initial registration decided in 80 total working days for complete applications
Abridged processing (ASEAN NRA-approved Class B/C/D): 30 working days from receipt of proof of payment (FDA Circular 2022-008)
ASEAN harmonization applies
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
Yes
Id
class-c
Class Name
Class C
Risk Level
high
Pathway
Registration
Official Timeline
Min
180
Max
180
Unit
days
Verification Status
official-verified
Official Source
Title
FDA Philippines AO 2018-0002 — statutory evaluation clocks
Url
https://elibrary.judiciary.gov.ph/thebookshelf/showdocs/10/89924
Accessed Date
2026-08-25
Realistic Timeline
Min
6
Max
12
Unit
months
With Prior Approval
Min
4
Max
7
Unit
months
Prior Approval Benefits
FDA
EU CE Mark
ASEAN MRA
Notes
AO 2018-0002 Sec. VII.A.4: initial applications evaluated within 180 days upon filing
Abridged processing (ASEAN NRA-approved): 30 working days (FDA Circular 2022-008)
Clinical data may be required
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
Yes
Id
class-d
Class Name
Class D
Risk Level
highest
Pathway
Full Registration
Official Timeline
Min
180
Max
180
Unit
days
Verification Status
official-verified
Official Source
Title
FDA Philippines AO 2018-0002 — statutory evaluation clocks
Url
https://elibrary.judiciary.gov.ph/thebookshelf/showdocs/10/89924
Accessed Date
2026-08-25
Realistic Timeline
Min
9
Max
18
Unit
months
With Prior Approval
Min
6
Max
10
Unit
months
Prior Approval Benefits
FDA PMA
EU CE Mark Class III
Notes
AO 2018-0002 Sec. VII.A.4: initial applications evaluated within 180 days upon filing
Abridged processing (ASEAN NRA-approved): 30 working days (FDA Circular 2022-008)
Clinical evidence required
Clinical Trial Required
Yes
Local Testing Required
No
Gmp Required
Yes

Expedited Pathways

Name
ASEAN Medical Device Directive (AMDD) harmonisation
Description
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.
Timeline Reduction
None — the saving is in dossier preparation, since one CSDT core can be reused across member states with national addenda
Eligibility
Any device filed in an ASEAN member state that has transposed the AMDD into national law

Prior Approvals

Authority
FDA 510(k)
Accepted
Yes
Benefit
Supports the Certificate of Free Sale and the CSDT technical evidence, but the Philippine FDA publishes no shorter period for it
Timeline Savings
None published
Authority
EU CE Mark
Accepted
Yes
Benefit
Supports the Certificate of Free Sale and the CSDT technical evidence, but the Philippine FDA publishes no shorter period for it
Timeline Savings
None published
Authority
ASEAN member-state registration
Accepted
No
Benefit
There is no ASEAN mutual recognition agreement for device registration — the AMDD harmonises the dossier, not the decision
Timeline Savings
None

Key Requirements

Philippines Local Agent
English/Filipino labeling
ISO 13485 certification
Free Sale Certificate
CPR (Certificate of Product Registration)
Renewals evaluated within 30 days upon filing (statutory); Citizen's Charter renewal turnaround 19 working days; variations also 19 working days
Deficiency response windows: 90 days (initial applications) or 30 days (others); IVD CPR initial registration runs 293 working days in the Citizen's Charter

Local Rep Required

Yes

Local Rep Name

Philippines Local Agent

Mdsap Accepted

Mdsap Benefit

Not accepted but ISO 13485 required

Registration Validity

5 years

Verification Status

official-verified

Official Sources

Title
FDA Philippines Citizen’s Charter 2025 — CDRRHR total processing times
Url
https://www.fda.gov.ph/citizen-charter-cdrrhr-2025/
Accessed Date
2026-08-25
Title
FDA Philippines AO 2018-0002 — statutory evaluation clocks
Url
https://elibrary.judiciary.gov.ph/thebookshelf/showdocs/10/89924
Accessed Date
2026-08-25
Title
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"
Url
https://www.ahwp.info/sites/default/files/6%20Implementing%20the%20ASEAN%20Medical%20Device%20Directive%201.0.pdf
Accessed Date
2026-08-30

Reviewed On

2026-08-30

Last Updated

2026-08-30

Process

Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps

Step
1
Title
Pre-Submission Preparation
Description
Gather technical documentation, quality management system (QMS) records, and clinical data required by FDA Philippines. Appoint a Philippines Local Agent.
Duration
1-3 months
Icon
📋
Step
2
Title
Application Submission
Description
Submit complete registration dossier to FDA Philippines including device description, risk analysis, and testing reports.
Duration
1-2 weeks
Icon
📤
Step
3
Title
Administrative Review
Description
FDA Philippines reviews application for completeness. May request additional documents or clarifications.
Duration
2-4 weeks
Icon
🔍
Step
4
Title
Technical Evaluation
Description
In-depth technical assessment of device safety and performance. FDA Philippines may issue questions.
Duration
23 working days
Icon
⚙️
Step
5
Title
Registration Approval
Description
Upon successful review, FDA Philippines issues Philippines market authorization certificate.
Duration
1-2 weeks
Icon
✅

Government fee schedules · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Philippines fees →

Jurisdiction Id

philippines

Country

Philippines

Country Code

Authority

FDA Philippines

Low Risk Local

Min: 5050
Max: 7575
Currency: PHP
Per Product: Yes

High Risk Local

Min: 3030
Max: 7575
Currency: PHP
Per Product: Yes

Details

Id
initial-cmdn-class-a
Item
Initial Certificate of Medical Device Notification - Class A
Currency
PHP
Amount Local
7575
Amount Local Formatted
PHP 7,575
Frequency
Per product
Notes
PHP 7,500 fee plus 1% Legal Research Fund charge; five-year validity.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.fda.gov.ph/wp-content/uploads/2024/04/6.-Center-for-Device-Regulation-Radiation-Health-and-Research-CDRRHR-External-Services.pdf
Source Title
FDA Philippines CDRRHR Citizen’s Charter: medical-device fees under the pre-AO 2024-0016 schedule
Verified On
2026-08-25
Id
initial-cmdr-class-b
Item
Initial Certificate of Medical Device Registration - Class B
Currency
PHP
Amount Local
7575
Amount Local Formatted
PHP 7,575
Frequency
Per product
Notes
PHP 7,500 fee plus 1% Legal Research Fund charge; five-year validity.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.fda.gov.ph/wp-content/uploads/2024/04/6.-Center-for-Device-Regulation-Radiation-Health-and-Research-CDRRHR-External-Services.pdf
Source Title
FDA Philippines CDRRHR Citizen’s Charter: medical-device fees under the pre-AO 2024-0016 schedule
Verified On
2026-08-25
Id
initial-cmdr-class-c-d
Item
Initial Certificate of Medical Device Registration - Class C/D
Currency
PHP
Amount Local
7575
Amount Local Formatted
PHP 7,575
Frequency
Per product
Notes
PHP 7,500 fee plus 1% Legal Research Fund charge; five-year validity.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.fda.gov.ph/wp-content/uploads/2024/04/6.-Center-for-Device-Regulation-Radiation-Health-and-Research-CDRRHR-External-Services.pdf
Source Title
FDA Philippines CDRRHR Citizen’s Charter: medical-device fees under the pre-AO 2024-0016 schedule
Verified On
2026-08-25
Id
temporary-cmdn-class-b-c-d
Item
Initial notification - Class B/C/D not yet included in the registrable-device list
Currency
PHP
Amount Local
3030
Amount Local Formatted
PHP 3,030
Frequency
Per product
Notes
PHP 3,000 fee plus 1% Legal Research Fund charge; two-year validity for this temporary notification route.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.fda.gov.ph/wp-content/uploads/2024/04/6.-Center-for-Device-Regulation-Radiation-Health-and-Research-CDRRHR-External-Services.pdf
Source Title
FDA Philippines CDRRHR Citizen’s Charter: medical-device fees under the pre-AO 2024-0016 schedule
Verified On
2026-08-25
Id
renewal-cmdn-cmdr-class-a-d
Item
CMDN/CMDR renewal - Class A/B/C/D
Currency
PHP
Amount Local
5050
Amount Local Formatted
PHP 5,050
Frequency
Per product renewal
Notes
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.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.fda.gov.ph/wp-content/uploads/2024/04/6.-Center-for-Device-Regulation-Radiation-Health-and-Research-CDRRHR-External-Services.pdf
Source Title
FDA Philippines CDRRHR Citizen’s Charter: medical-device fees under the pre-AO 2024-0016 schedule
Verified On
2026-08-25
Id
variation-application
Item
Variation of CMDR / CPR-IVD - application
Currency
PHP
Amount Local
510
Amount Local Formatted
PHP 510
Frequency
Per application
Notes
PHP 500 fee plus PHP 10 Legal Research Fund charge.
Amount Status
exact-current
Verification Status
official-verified
Source Url
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
Source Title
FDA Philippines Citizen’s Charter 2025, Chart 8: variation of CMDR / CPR-IVD
Verified On
2026-08-25
Id
variation-brand-name-change
Item
Variation - change in brand name
Currency
PHP
Amount Local
2525
Amount Local Formatted
PHP 2,525
Frequency
Per application
Notes
PHP 2,500 fee plus 1% Legal Research Fund charge.
Amount Status
exact-current
Verification Status
official-verified
Source Url
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
Source Title
FDA Philippines Citizen’s Charter 2025, Chart 8: variation of CMDR / CPR-IVD
Verified On
2026-08-25
Id
variation-shelf-life-extension
Item
Variation - shelf-life extension
Currency
PHP
Amount Local
1010
Amount Local Formatted
PHP 1,010
Frequency
Per application
Notes
PHP 1,000 fee plus 1% Legal Research Fund charge.
Amount Status
exact-current
Verification Status
official-verified
Source Url
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
Source Title
FDA Philippines Citizen’s Charter 2025, Chart 8: variation of CMDR / CPR-IVD
Verified On
2026-08-25
Id
compassionate-special-permit
Item
Compassionate Special Permit - device
Currency
PHP
Amount Local
510
Amount Local Formatted
PHP 510
Frequency
Per application
Notes
PHP 500 fee plus PHP 10 Legal Research Fund charge.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.fda.gov.ph/wp-content/uploads/2025/09/19.-Issuance-of-Compassionate-Special-Permit-CSP.pdf
Source Title
FDA Philippines Citizen’s Charter 2025, Chart 19: Compassionate Special Permit
Verified On
2026-08-25
Id
cpr-ivd-initial-1-year
Item
CPR for IVD initial application - 1-year validity
Currency
PHP
Amount Local
1515
Amount Local Formatted
PHP 1,515
Frequency
Per product
Notes
PHP 1,500 fee plus 1% Legal Research Fund charge; excludes performance-evaluation test cost.
Amount Status
exact-current
Verification Status
official-verified
Source Url
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
Source Title
FDA Philippines Citizen’s Charter 2025, Chart 6: CPR for IVD initial application
Verified On
2026-08-25
Id
cpr-ivd-initial-hcg-6-year
Item
CPR for IVD initial application - hCG products, 6-year validity
Currency
PHP
Amount Local
2525
Amount Local Formatted
PHP 2,525
Frequency
Per product
Notes
PHP 2,500 fee plus 1% Legal Research Fund charge; hCG products requiring performance evaluation add PHP 1,000.
Amount Status
exact-current
Verification Status
official-verified
Source Url
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
Source Title
FDA Philippines Citizen’s Charter 2025, Chart 6: CPR for IVD initial application
Verified On
2026-08-25
Id
lto-retailer-initial
Item
Licence to Operate - medical-device retailer, initial
Currency
PHP
Amount Local
2000
Amount Local Formatted
PHP 2,000
Frequency
Per licence, valid 2 years
Notes
Plus 1% Legal Research Fund charge (FDA Circular 2021-0021 Sec. V.D, mirroring AO 50 s. 2001).
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.fda.gov.ph/fda-circular-no-2021-0021-guidelines-on-the-licensing-of-retailers-of-medical-devices-in-the-philippines/
Source Title
FDA Philippines Circular 2021-0021: licensing of medical-device retailers
Source Effective Date
2021-01-01
Verified On
2026-08-25
Id
lto-retailer-renewal
Item
Licence to Operate - medical-device retailer, renewal
Currency
PHP
Amount Local
3000
Amount Local Formatted
PHP 3,000
Frequency
Per renewal, valid 3 years
Notes
Plus 1% Legal Research Fund charge.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.fda.gov.ph/fda-circular-no-2021-0021-guidelines-on-the-licensing-of-retailers-of-medical-devices-in-the-philippines/
Source Title
FDA Philippines Circular 2021-0021: licensing of medical-device retailers
Source Effective Date
2021-01-01
Verified On
2026-08-25
Id
lto-retailer-variation
Item
Licence to Operate - variation
Currency
PHP
Amount Local
500
Amount Local Formatted
PHP 500
Frequency
Per variation
Notes
Plus 1% Legal Research Fund charge.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.fda.gov.ph/fda-circular-no-2021-0021-guidelines-on-the-licensing-of-retailers-of-medical-devices-in-the-philippines/
Source Title
FDA Philippines Circular 2021-0021: licensing of medical-device retailers
Source Effective Date
2021-01-01
Verified On
2026-08-25

Notes

The newer AO 2024-0016 fee schedule remains suspended while the Department of Health and FDA review and amend it.
The table therefore shows the pre-AO 2024-0016 medical-device amounts published in FDA Philippines’ CDRRHR Citizen’s Charter, including the 1% Legal Research Fund charge.
Department Circular 2026-0329 extended the suspension from 9 June 2026 for another 120 working days or until the State of National Energy Emergency is lifted, whichever is longer. Recheck FDA eServices before payment because a later issuance can lift the suspension.
Turned-initial applications (expired more than 120 days) add a PHP 12,000 penalty, e.g. PHP 19,575 total for a Class B CMDR initial.

Last Updated

2026-08-25

Verification Status

official-verified

Official Sources

Title
FDA Philippines CDRRHR Citizen’s Charter: medical-device fees under the pre-AO 2024-0016 schedule
Url
https://www.fda.gov.ph/wp-content/uploads/2024/04/6.-Center-for-Device-Regulation-Radiation-Health-and-Research-CDRRHR-External-Services.pdf
Accessed Date
2026-08-25
Title
DOH Department Circular 2026-0329: further 120-working-day AO 2024-0016 suspension
Url
https://www.fda.gov.ph/wp-content/uploads/2026/06/Department-Circular-No.2026-0329.pdf
Effective Date
2026-06-09
Accessed Date
2026-08-25
Title
DOH Department Circular 2025-0382: extension of AO 2024-0016 suspension
Url
https://www.fda.gov.ph/wp-content/uploads/2025/09/Department-Circular-No.-2025-0382.pdf
Effective Date
2025-09-05
Accessed Date
2026-08-25
Title
2026 stakeholder consultation on amendment of AO 2024-0016
Url
https://www.fda.gov.ph/announcement-stakeholder-survey-for-participation-in-the-public-consultation-on-the-amendment-of-administrative-order-no-2024-0016/
Effective Date
2026-03-30
Accessed Date
2026-08-25
Title
Philippines FDA AO 2024-0016 fee schedule
Url
https://www.fda.gov.ph/administrative-order-implementing-guidelines-on-the-new-schedule-of-fees-and-charges-of-the-food-and-drug-administration/
Effective Date
2025-01-12
Accessed Date
2026-08-25
Title
FDA Philippines Citizen’s Charter 2025, Chart 8: variation of CMDR / CPR-IVD
Url
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
Accessed Date
2026-08-25
Title
FDA Philippines Citizen’s Charter 2025, Chart 19: Compassionate Special Permit
Url
https://www.fda.gov.ph/wp-content/uploads/2025/09/19.-Issuance-of-Compassionate-Special-Permit-CSP.pdf
Accessed Date
2026-08-25
Title
FDA Philippines Citizen’s Charter 2025, Chart 6: CPR for IVD initial application
Url
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
Accessed Date
2026-08-25
Title
FDA Philippines Circular 2021-0021: licensing of medical-device retailers
Url
https://www.fda.gov.ph/fda-circular-no-2021-0021-guidelines-on-the-licensing-of-retailers-of-medical-devices-in-the-philippines/
Effective Date
2021-01-01
Accessed Date
2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Philippines certifications →

Slug

philippines

Market

Philippines

Confidence

low

Schemes

Id
fda-electrical-emc-evidence
Name
FDA electrical/EMC evidence
Category
Medical Electrical Safety
Status
Included In Medical Registration
Object
Finished Device
Note
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.
Source Binding
unresolved
Id
ntc-type-acceptance
Name
NTC Type Acceptance
Category
Radio Spectrum
Status
Mandatory If Feature
Object
Radio Communications Equipment
Source Urls
https://ntc.gov.ph/downloadable-forms-2/
Source Binding
candidate
Id
ntc-type-approval
Name
NTC Type Approval
Category
Telecom Network Attachment
Status
Mandatory If Feature
Object
Customer Premises Equipment
Source Urls
https://ntc.gov.ph/downloadable-forms-2/
Source Binding
candidate
Id
ntc-general-equipment-certificate
Name
NTC General Equipment Certificate
Category
Radio Spectrum
Status
Mandatory If Feature
Object
Customer Premises Equipment With Integrated Radio
Source Urls
https://ntc.gov.ph/downloadable-forms-2/
Source Binding
candidate
Id
bps-ps-icc-mark
Name
BPS PS/ICC mark
Category
General Electrical Components
Status
Mandatory If Feature
Object
Mandatory List Product Or Component
Source Binding
unresolved
Id
fda-cdrrhr-facility-lto
Name
FDA CDRRHR facility LTO
Category
Ionizing Radiation
Status
Mandatory For Use Site
Object
Radiation Facility
Source Urls
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/
Source Binding
candidate
Id
metrology-certificate-of-conformity
Name
Metrology Certificate of Conformity
Category
Legal Metrology
Status
Mandatory If Feature
Object
Device With Measuring Function
Note
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.
Source Urls
https://www.fda.gov.ph/wp-content/uploads/2025/09/20.-Issuance-of-Certificate-of-Medical-Device-Notification-Initial-Application.pdf
Source Binding
reviewed

Official Sources

Authority
NTC
Topic
type approval, type acceptance and GEC forms
Url
https://ntc.gov.ph/downloadable-forms-2/
Authority
FDA Philippines
Topic
radiation-facility licensing and registration
Url
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/
Authority
FDA Philippines
Topic
CMDN initial application charts metrology certificate and standards declaration
Url
https://www.fda.gov.ph/wp-content/uploads/2025/09/20.-Issuance-of-Certificate-of-Medical-Device-Notification-Initial-Application.pdf