FDA Ghana · structured requirements

🇬🇭 Ghana IVD regulatory data

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

6 facts2 dimensions2 official sourceslatest verification 2026-09-15

Changes after registration in Ghana

Source-linked rules for common changes to a registered IVD. Read the scope and conditions with each rule; unverified details are listed separately.

Does changing a device brand name or logo require an update?

A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.

A source-verified answer for this specific scenario is not yet published.

How do I update a manufacturer's name without changing the legal entity?

The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.

A source-verified answer for this specific scenario is not yet published.

What changes when the manufacturer's office address changes?

An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.

A source-verified answer for this specific scenario is not yet published.

Does a catalogue or reference code change affect registration or UDI?

Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.

A source-verified answer for this specific scenario is not yet published.

Can a registration transfer to a different legal entity?

A real change of legal manufacturer, registration holder or owner. This differs from renaming the same entity; a change of local representative or importer alone does not establish a registration transfer route. Where other changes occur with the transfer, the exact combination and sequence need separate evidence.

A source-verified answer for this specific scenario is not yet published.

Can several changes be filed together?

Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.

A source-verified answer for this specific scenario is not yet published.

Classification rules

What local class follows from which rules and decisive product facts?

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Classification detail 2

classification.detail-2

Fact-level verified

Where a device can be classified into more than one class, the higher-risk class applies

Classification detail 3

classification.detail-3

Fact-level verified

Non-IVD classification rules (Appendix IV Part 1, Rules 1-16, GHTF/CMDR-style): surgically invasive devices default Class II; surgically invasive devices for central cardiovascular/central nervous system or fetus in utero are Class IV; absorbable or >=30-day implants Class III; body-orifice devices >=30 days Class III; barrier contraceptives Class III; surgical/dental instruments Class I; latex condoms Class II; non-invasive devices modifying blood/body fluids Class III (Class IV if hazardous foreign substance introduced); ionizing-radiation active devices Class III (radiographic mode Class II; mammography Class III); closed-loop therapeutic control Class IV; disinfecting/sterilizing devices for transfusion/transplantation tissues Class IV, for devices Class II; tissues/recombinant-DNA devices Class IV; special table: breast implants and tissue expanders Class IV

Classification detail 4

classification.detail-4

Fact-level verified

IVD classification rules (Appendix IV Part 2, Rules 1-4): IVDs detecting transmissible agents in blood/tissues for transfusion or transplantation suitability are Class IV; transmissible-agent IVDs default Class II, upgraded to Class IV for life-threatening disease with propagation risk in the Ghanaian population and Class III for serious disease propagation risk, sexually transmitted agents, cerebrospinal fluid/blood infectious agents, or erroneous results risking death or severe disability; patient-management IVDs default Class II, Class III for life-threatening disease management or imminent life-threatening decisions from erroneous results

Classification detail 5

classification.detail-5

Fact-level verified

SaMD is separately categorised into four categories (I-IV) based on the level of impact on healthcare/patient identified in the SaMD definition statement, independent of the device class scheme; highest category applies when multiple statements fit

Classification scheme (full axis)

classification.scheme-classes

Fact-level verified

Axis

Risk classes I through IV (FDA Ghana registration guidelines, GHTF/CMDR-style rules).

Classes

Id
i
Label
Class I
Normalized Risk Level
low
Id
ii
Label
Class II
Normalized Risk Level
medium
Id
iii
Label
Class III
Normalized Risk Level
high
Id
iv
Label
Class IV
Normalized Risk Level
highest

Regulator

FDA Ghana

Notes

Class I lowest risk to Class IV highest (Section 3.3.1-3.3.3); where a device can be classified into more than one class, the higher-risk class applies (Section 3.3.2).
Appendix IV Part 1 Rules 1-16 (GHTF/CMDR-style): surgically invasive devices default Class II; central cardiovascular/CNS or fetus-in-utero devices Class IV; absorbable or >=30-day implants Class III; surgical/dental instruments Class I; latex condoms Class II; blood/body-fluid modifying devices Class III (IV if hazardous foreign substance); ionizing-radiation active devices Class III (radiographic mode Class II); closed-loop therapeutic control Class IV; transfusion/transplant tissue sterilizers Class IV; breast implants and tissue expanders Class IV.
Appendix IV Part 2 IVD Rules 1-4: transfusion/transplant transmissible-agent screening Class IV; life-threatening disease with Ghanaian-population propagation risk Class IV; STD agents, cerebrospinal-fluid/blood infectious agents, or erroneous results risking death/severe disability Class III; patient-management IVDs default Class II, Class III for life-threatening disease management.
SaMD is separately categorized into four categories (I-IV) by level of impact on healthcare/patient, independent of the device class scheme (SaMD registration guideline, Section 4.3.1).

Reliance & recognition

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

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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.

Ghana 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 Ghana (5 records)

GhanaEU conformity assessment

Prior approval / evidence record

CE Mark (EU MDR)

Authority: CE Mark (EU MDR)
Accepted: Yes
Benefit: A CE certificate is the technical dossier and QMS evidence behind a reliance submission, and supports a desk-review waiver of the QMS audit.
Timeline Savings: None published

FDA Ghana Client Service Delivery Charter (2020 edition) — market authorisation for medical devices: fresh Class I-IV within 6 months, renewal within 3 months, minor variation 3 months, major variation 6 months FDA Ghana — Guideline for Registration of Medical Devices (FDA/MCH/MDD/GL-RMD/2013/01 v02, issued 1 March 2016), section 4.0 timelines and section 3.1.7 evaluation process

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

GhanaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: Serves the same role as a CE certificate in a reliance submission.
Timeline Savings: None published

FDA Ghana Client Service Delivery Charter (2020 edition) — market authorisation for medical devices: fresh Class I-IV within 6 months, renewal within 3 months, minor variation 3 months, major variation 6 months FDA Ghana — Guideline for Registration of Medical Devices (FDA/MCH/MDD/GL-RMD/2013/01 v02, issued 1 March 2016), section 4.0 timelines and section 3.1.7 evaluation process

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

GhanaSource authority not specified

Prior approval / evidence record

Decision of another well-resourced national regulatory authority

Authority: Decision of another well-resourced national regulatory authority
Accepted: Yes
Benefit: The FDA operates an explicit reliance mechanism, granting market authorisation on the strength of another authority’s decision and exchanging scientific assessments, safety data and inspection reports to support it. No separate period is published for the reliance route.
Timeline Savings: None published

FDA Ghana Client Service Delivery Charter (2020 edition) — market authorisation for medical devices: fresh Class I-IV within 6 months, renewal within 3 months, minor variation 3 months, major variation 6 months FDA Ghana — Guideline for Registration of Medical Devices (FDA/MCH/MDD/GL-RMD/2013/01 v02, issued 1 March 2016), section 4.0 timelines and section 3.1.7 evaluation process

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

Regulatory reference

China NMPA approval: no recognition regime

reliance.china-nmpa-no-recognition-route

Pending verification

Statement: FDA Ghana's Guidelines for the Registration of Medical Devices (FDA/MCH/MDD/GL-RMD/2013/01, Version 02, issued 1 March 2016) prescribe a full technical dossier (device description, evidence of conformity to Essential Principles via the Annex II checklist, materials, specifications, verification and validation, biocompatibility, clinical evidence, labelling) with no abridged route, no list of reference regulatory agencies and no requirement for a certificate of free sale or country-of-origin approval. A prior NMPA approval is therefore neither required nor recognised in the standard registration procedure; any credit for foreign approval arises only through the separate reliance guideline.
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: ghana
China Classes In Scope: all classes under the device registration guideline (full dossier review)
Edge Type: No Reliance Route
Market Access Strength: none
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Documents not in English must be translated and authenticated at a Ghana embassy or by the NRA of the originating country (3.1.5).
Certified copies must be certified by a lawyer in the manufacturer's country of origin (Glossary).
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 2016-03-01

Source passage: 3.2 Evidence of Conformity to Essential Principles. Provide evidence of conformity to Essential Principles of Safety and Performance (EPSP) by completing the checklist appended as Annex II. [...] 3.5.1.7 Declarations/certificate of compliance to a recognized standard as applied by the manufacturer should be provided.

Prior approval / evidence record

WHO prequalification (Collaborative Registration Procedure)

Authority: WHO prequalification (Collaborative Registration Procedure)
Accepted: Yes
Benefit: The FDA grants market authorisation for WHO-prequalified devices through the WHO collaborative registration procedure, which it describes as accelerated. No period is published for the device CRP, so the acceleration is real but unquantified.
Timeline Savings: Not quantified — the FDA calls the route accelerated without publishing a period

FDA Ghana Client Service Delivery Charter (2020 edition) — market authorisation for medical devices: fresh Class I-IV within 6 months, renewal within 3 months, minor variation 3 months, major variation 6 months FDA Ghana — Guideline for Registration of Medical Devices (FDA/MCH/MDD/GL-RMD/2013/01 v02, issued 1 March 2016), section 4.0 timelines and section 3.1.7 evaluation process

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

Related structured datasets

Classification systems · 1 record

Open Risk classes I through IV (FDA Ghana registration guidelines, GHTF/CMDR-style rules). →

Id

ghana:medical-device

Jurisdiction Id

ghana

Domains

medical-device
ivd

Name

Risk classes I through IV (FDA Ghana registration guidelines, GHTF/CMDR-style rules).

Classes

Id
i
Label
Class I
Normalized Risk Level
low
Id
ii
Label
Class II
Normalized Risk Level
medium
Id
iii
Label
Class III
Normalized Risk Level
high
Id
iv
Label
Class IV
Normalized Risk Level
highest

Regulator

FDA Ghana

Official Domains

fdaghana.gov.gh

Notes

Class I lowest risk to Class IV highest (Section 3.3.1-3.3.3); where a device can be classified into more than one class, the higher-risk class applies (Section 3.3.2).
Appendix IV Part 1 Rules 1-16 (GHTF/CMDR-style): surgically invasive devices default Class II; central cardiovascular/CNS or fetus-in-utero devices Class IV; absorbable or >=30-day implants Class III; surgical/dental instruments Class I; latex condoms Class II; blood/body-fluid modifying devices Class III (IV if hazardous foreign substance); ionizing-radiation active devices Class III (radiographic mode Class II); closed-loop therapeutic control Class IV; transfusion/transplant tissue sterilizers Class IV; breast implants and tissue expanders Class IV.
Appendix IV Part 2 IVD Rules 1-4: transfusion/transplant transmissible-agent screening Class IV; life-threatening disease with Ghanaian-population propagation risk Class IV; STD agents, cerebrospinal-fluid/blood infectious agents, or erroneous results risking death/severe disability Class III; patient-management IVDs default Class II, Class III for life-threatening disease management.
SaMD is separately categorized into four categories (I-IV) by level of impact on healthcare/patient, independent of the device class scheme (SaMD registration guideline, Section 4.3.1).

Source Status

official-source-verified

Source Title

FDA Ghana — Guidelines for the Registration of Medical Devices, Section 3.3 and Appendix IV

Source Url

https://fdaghana.gov.gh/guidelines-for-the-registration-of-medical-devices

Verified On

2026-08-25

Source Supports

class-axis
classification-rules
ivd-class-axis
ivd-classification-rules

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 Ghana registration →

Country

Ghana

Jurisdiction Id

ghana

Country Code

GH

Flag

🇬🇭

Regulator

Ghana Food and Drugs Authority

Regulator Abbrev

FDA Ghana

Region

africa

Tier

3

Risk Classification

4-class (A, B, C, D) — EU-aligned

Classes

Id
device-registration
Class Name
Medical-device registration (Class I-IV)
Pathway
FDA Ghana registration
Official Timeline
Min
6
Max
6
Unit
months
Realistic Timeline
Min
7
Max
10
Unit
months
Notes
Client Service Delivery Charter: fresh applications for Class I to IV devices, foreign and local alike, are processed within 6 months
The 2016 registration guideline states the same six months as a minimum rather than a ceiling, so the charter is the more favourable framing of the identical figure and the guideline is the more candid one
Neither instrument splits the clock by risk class: the four classes share one period
Gmp Required
Yes
Verification Status
official-verified
Official Source
Title
FDA Ghana Client Service Delivery Charter (2020 edition) — market authorisation for medical devices: fresh Class I-IV within 6 months, renewal within 3 months, minor variation 3 months, major variation 6 months
Url
https://fdaghana.gov.gh/fda-client-service-delivery-charter
Effective Date
2020-01-01
Accessed Date
2026-08-30
Id
registration-renewal
Class Name
Registration renewal (Class I-IV)
Pathway
FDA Ghana renewal
Official Timeline
Min
3
Max
3
Unit
months
Realistic Timeline
Min
3
Max
6
Unit
months
Notes
Client Service Delivery Charter: renewal applications for Class I to IV devices are processed within 3 months, foreign and local alike
The guideline requires the renewal to be filed at least 3 months before the existing registration expires, so the filing lead time and the processing time are the same length and only just meet
Renewals qualify for expedited evaluation under guideline §3.1.7.2.5 rather than the default first-in-first-out queue
Gmp Required
Yes
Verification Status
official-verified
Official Source
Title
FDA Ghana Client Service Delivery Charter (2020 edition) — market authorisation for medical devices: fresh Class I-IV within 6 months, renewal within 3 months, minor variation 3 months, major variation 6 months
Url
https://fdaghana.gov.gh/fda-client-service-delivery-charter
Effective Date
2020-01-01
Accessed Date
2026-08-30
Id
minor-variation
Class Name
Minor variation
Pathway
FDA Ghana variation
Official Timeline
Min
3
Max
3
Unit
months
Realistic Timeline
Min
3
Max
5
Unit
months
Notes
Client Service Delivery Charter: minor variations are processed within 3 months
Post-approval variations are an expedited category under guideline §3.1.7.2.4
Gmp Required
No
Verification Status
official-verified
Official Source
Title
FDA Ghana Client Service Delivery Charter (2020 edition) — market authorisation for medical devices: fresh Class I-IV within 6 months, renewal within 3 months, minor variation 3 months, major variation 6 months
Url
https://fdaghana.gov.gh/fda-client-service-delivery-charter
Effective Date
2020-01-01
Accessed Date
2026-08-30
Id
major-variation
Class Name
Major variation
Pathway
FDA Ghana variation
Official Timeline
Min
6
Max
6
Unit
months
Realistic Timeline
Min
6
Max
9
Unit
months
Notes
Client Service Delivery Charter: major variations are processed within 6 months, the same period as a fresh application
The guideline treats changes to manufacturing process, quality-control procedures, device design or intended use as the significant changes that trigger this route
Gmp Required
Yes
Verification Status
official-verified
Official Source
Title
FDA Ghana Client Service Delivery Charter (2020 edition) — market authorisation for medical devices: fresh Class I-IV within 6 months, renewal within 3 months, minor variation 3 months, major variation 6 months
Url
https://fdaghana.gov.gh/fda-client-service-delivery-charter
Effective Date
2020-01-01
Accessed Date
2026-08-30
Id
foreign-facility-gmp-certificate
Class Name
GMP certificate for a foreign manufacturing facility
Pathway
FDA Ghana facility certification
Official Timeline
Min
3
Max
3
Unit
months
Realistic Timeline
Min
3
Max
6
Unit
months
Notes
Client Service Delivery Charter: new applications within 3 months and renewals within 2 months
No product is registered unless the facility complies with cGMP, so for a new manufacturing site this period runs before the registration decision rather than alongside it
Gmp Required
Yes
Verification Status
official-verified
Official Source
Title
FDA Ghana Client Service Delivery Charter (2020 edition) — market authorisation for medical devices: fresh Class I-IV within 6 months, renewal within 3 months, minor variation 3 months, major variation 6 months
Url
https://fdaghana.gov.gh/fda-client-service-delivery-charter
Effective Date
2020-01-01
Accessed Date
2026-08-30
Id
local-manufacturing-licence
Class Name
Manufacturing licence for a local facility
Pathway
FDA Ghana premises registration
Official Timeline
Min
4
Max
4
Unit
weeks
Realistic Timeline
Min
1
Max
3
Unit
months
Notes
Client Service Delivery Charter: new applications within 4 weeks and renewals within 3 weeks, covering medical device facilities alongside human, veterinary, herbal, cosmetic and household chemical ones
Gmp Required
Yes
Verification Status
official-verified
Official Source
Title
FDA Ghana Client Service Delivery Charter (2020 edition) — market authorisation for medical devices: fresh Class I-IV within 6 months, renewal within 3 months, minor variation 3 months, major variation 6 months
Url
https://fdaghana.gov.gh/fda-client-service-delivery-charter
Effective Date
2020-01-01
Accessed Date
2026-08-30

Key Requirements

Local Authorized Representative required for foreign manufacturers
Evaluation runs first-in-first-out unless the product qualifies for expedited handling, which the guideline limits to public health programmes (HIV/AIDS, malaria, tuberculosis, reproductive health, neglected tropical diseases), paediatric programmes, Ministry of Health tender purposes, post-approval variations and renewals
A query stops the clock outright: evaluation halts until a written response arrives, everything asked for in one deferral letter must come back in a single submission, a third round of unsatisfactory answers means rejection, and no response within 12 months means the application is treated as withdrawn
The Product Registration Committee makes the final grant, reject or defer decision after label review, dossier evaluation, laboratory analysis and GMP status reports are assembled
Border and trade services carry their own charter clocks: import permits and clearance of imported products within 1 day each, export permits within 1 week, certificates of free sale within 2 weeks, and listing of importers within 3 weeks
Clinical trial services under the same charter: routine-pathway authorisation within 60 days, reliance-pathway within 30 days, protocol amendments within 30 days, import permits for investigational products within 10 days, quarterly progress and safety reports within 15 days, and GCP inspection findings communicated within 21 days
Condoms carry extra conditions: 1,600 sample pieces, a mandatory foreign facility inspection, and batch-by-batch detention and laboratory release of every imported consignment

Prior Approvals

Authority
WHO prequalification (Collaborative Registration Procedure)
Accepted
Yes
Benefit
The FDA grants market authorisation for WHO-prequalified devices through the WHO collaborative registration procedure, which it describes as accelerated. No period is published for the device CRP, so the acceleration is real but unquantified.
Timeline Savings
Not quantified — the FDA calls the route accelerated without publishing a period
Authority
Decision of another well-resourced national regulatory authority
Accepted
Yes
Benefit
The FDA operates an explicit reliance mechanism, granting market authorisation on the strength of another authority’s decision and exchanging scientific assessments, safety data and inspection reports to support it. No separate period is published for the reliance route.
Timeline Savings
None published
Authority
CE Mark (EU MDR)
Accepted
Yes
Benefit
A CE certificate is the technical dossier and QMS evidence behind a reliance submission, and supports a desk-review waiver of the QMS audit.
Timeline Savings
None published
Authority
FDA 510(k)/PMA
Accepted
Yes
Benefit
Serves the same role as a CE certificate in a reliance submission.
Timeline Savings
None published

Local Rep Required

Yes

Local Rep Name

Ghanaian Authorized Representative

Mdsap Accepted

No

Mdsap Benefit

Not accepted

Registration Validity

Not published; the guideline fixes only the filing lead time, requiring renewal at least 3 months before the existing registration expires

Last Updated

2026-08-30

Verification Status

official-verified

Official Sources

Title
FDA Ghana Client Service Delivery Charter (2020 edition) — market authorisation for medical devices: fresh Class I-IV within 6 months, renewal within 3 months, minor variation 3 months, major variation 6 months
Url
https://fdaghana.gov.gh/fda-client-service-delivery-charter
Effective Date
2020-01-01
Accessed Date
2026-08-30
Title
FDA Ghana — Guideline for Registration of Medical Devices (FDA/MCH/MDD/GL-RMD/2013/01 v02, issued 1 March 2016), section 4.0 timelines and section 3.1.7 evaluation process
Url
https://fdaghana.gov.gh/guidelines-for-the-registration-of-medical-devices
Effective Date
2016-03-01
Accessed Date
2026-08-30

Reviewed On

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 Ghana. Appoint a Ghanaian Authorized Representative.
Duration
1-3 months
Icon
📋
Step
2
Title
Application Submission
Description
Submit complete registration dossier to FDA Ghana including device description, risk analysis, and testing reports.
Duration
1-2 weeks
Icon
📤
Step
3
Title
Administrative Review
Description
FDA Ghana 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 Ghana may issue questions.
Duration
6 months
Icon
⚙️
Step
5
Title
Registration Approval
Description
Upon successful review, FDA Ghana issues Ghana 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 Ghana fees →

Jurisdiction Id

ghana

Country

Ghana

Country Code

GH

Authority

FDA Ghana

Low Risk Local

Min: 60
Max: 60
Currency: USD
Per Product: Yes

High Risk Local

Min: 160
Max: 160
Currency: USD
Per Product: Yes

Details

Id
imported-registration-class-i
Item
Imported product registration - Class I (low risk)
Currency
USD
Amount Local
60
Amount Local Formatted
USD 60
Frequency
Per product, per annum
Notes
Payable in cedi equivalent.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://fdaghana.gov.gh/img/appfees
Source Title
Ghana FDA current fee schedule
Verified On
2026-08-25
Id
imported-registration-class-ii
Item
Imported product registration - Class II (medium risk)
Currency
USD
Amount Local
100
Amount Local Formatted
USD 100
Frequency
Per product, per annum
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://fdaghana.gov.gh/img/appfees
Source Title
Ghana FDA current fee schedule
Verified On
2026-08-25
Id
imported-registration-class-iii-iv
Item
Imported product registration - Class III/IV (high risk)
Currency
USD
Amount Local
160
Amount Local Formatted
USD 160
Frequency
Per product, per annum
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://fdaghana.gov.gh/img/appfees
Source Title
Ghana FDA current fee schedule
Verified On
2026-08-25
Id
local-registration-annual-fee
Item
Locally manufactured product registration
Currency
GHS
Amount Local
250
Amount Local Formatted
GH¢ 250
Frequency
Per product, per annum
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://fdaghana.gov.gh/img/appfees
Source Title
Ghana FDA current fee schedule
Verified On
2026-08-25
Id
variation-foreign-major
Item
Major variation - foreign products
Currency
USD
Amount Local
500
Amount Local Formatted
USD 500
Frequency
Per variation
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://fdaghana.gov.gh/img/appfees
Source Title
Ghana FDA current fee schedule
Verified On
2026-08-25
Id
variation-foreign-minor
Item
Minor variation - foreign products
Currency
USD
Amount Local
300
Amount Local Formatted
USD 300
Frequency
Per variation
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://fdaghana.gov.gh/img/appfees
Source Title
Ghana FDA current fee schedule
Verified On
2026-08-25
Id
variation-local-major
Item
Major variation - local products
Currency
GHS
Amount Local
200
Amount Local Formatted
GH¢ 200
Frequency
Per variation
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://fdaghana.gov.gh/img/appfees
Source Title
Ghana FDA current fee schedule
Verified On
2026-08-25
Id
variation-local-minor
Item
Minor variation - local products
Currency
GHS
Amount Local
100
Amount Local Formatted
GH¢ 100
Frequency
Per variation
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://fdaghana.gov.gh/img/appfees
Source Title
Ghana FDA current fee schedule
Verified On
2026-08-25
Id
foreign-gmp-audit
Item
Foreign GMP audit
Currency
USD
Amount Local
4000
Amount Local Min
4000
Amount Local Max
7500
Amount Local Formatted
USD 4,000–7,500
Frequency
Per audit
Notes
USD 4,000 for sites in Africa; USD 7,500 outside Africa.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://fdaghana.gov.gh/img/appfees
Source Title
Ghana FDA current fee schedule
Verified On
2026-08-25
Id
local-facility-inspection
Item
Local facility inspection
Currency
GHS
Amount Local
200
Amount Local Min
50
Amount Local Max
400
Amount Local Formatted
GH¢ 50–400
Frequency
Per inspection
Notes
Tiered by facility size (GH¢ 400/200/100/50); free-zone facilities pay GH¢ 5,000.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://fdaghana.gov.gh/img/appfees
Source Title
Ghana FDA current fee schedule
Verified On
2026-08-25
Id
storage-inspection
Item
Storage-facility inspection
Currency
GHS
Amount Local
240
Amount Local Min
120
Amount Local Max
800
Amount Local Formatted
GH¢ 120–800
Frequency
Per inspection
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://fdaghana.gov.gh/img/appfees
Source Title
Ghana FDA current fee schedule
Verified On
2026-08-25
Id
ivd-laboratory-analysis
Item
IVD laboratory analysis
Currency
GHS
Amount Local
2500
Amount Local Formatted
GH¢ 2,500
Frequency
Per analysis
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://fdaghana.gov.gh/img/appfees
Source Title
Ghana FDA current fee schedule
Verified On
2026-08-25
Id
equipment-verification
Item
Equipment verification
Currency
GHS
Amount Local
2000
Amount Local Formatted
GH¢ 2,000
Frequency
Per verification
Notes
Re-analysis after failure: GH¢ 150 per sample.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://fdaghana.gov.gh/img/appfees
Source Title
Ghana FDA current fee schedule
Verified On
2026-08-25
Id
advertisement-approval
Item
Advertisement approval
Currency
GHS
Amount Local
600
Amount Local Formatted
GH¢ 600
Frequency
Per script, language and medium
Notes
Fast-track: GH¢ 1,800; airing an unapproved advertisement: GH¢ 25,000.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://fdaghana.gov.gh/img/appfees
Source Title
Ghana FDA current fee schedule
Verified On
2026-08-25

Notes

Verification of imported registered equipment is charged at 1.30% of CIF value (formula, not tabulated as an exact row).
Imported registration fees are quoted in USD but collected in cedi equivalent.

Last Updated

2026-08-25

Verification Status

official-verified

Official Sources

Title
Ghana FDA current fee schedule
Url
https://fdaghana.gov.gh/img/appfees
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 Ghana certifications →

Slug

ghana

Market

Ghana

Confidence

low

Schemes

Id
fda-ghana-essential-principles-sted-evidence
Name
FDA Ghana essential-principles STED evidence
Category
Medical Electrical Safety
Status
Included In Medical Registration
Object
Finished Device
Note
The conformity framework is GHTF-based: manufacturers demonstrate conformity with the Essential Principles of Safety and Performance (GHTF/SG1/N68:2012) via STED documentation; declarations or certificates of compliance to a recognised standard may be submitted as evidence; 'National Standard' means a standard prescribed by the Ghana Standards Authority (glossary; Appendix III 3.5.1.7). No mandatory ISO 13485 certificate or notified-body scheme is stated — cGMP/QMS is verified by FDA inspection.
Source Urls
https://fdaghana.gov.gh/guidelines-for-the-registration-of-medical-devices
Source Binding
reviewed

Official Sources

Authority
FDA Ghana
Topic
guidelines for the registration of medical devices — recognised standards, STED evidence
Url
https://fdaghana.gov.gh/guidelines-for-the-registration-of-medical-devices

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