Explore the medical device requirements currently available for Ghana, organized by topic and linked to official sources.
Which claims, audiences, channels, approvals, and restrictions apply?
A person shall not advertise a medical device to the general public as a treatment, preventive or cure for a disease, disorder or an abnormal physical state unless the advertisement has been approved by the Authority.
Fee schedule prices advertisement applications per script, per language, per medium.
Despite the approval mechanism, a person shall not advertise a medical device for the treatment or cure of diseases specified in the Fifth Schedule to Act 851.
What expires, what is retained periodically, and when must renewal start?
Applications for renewal of device registration must be made at least 3 months before expiry of the existing registration, with a completed renewal form, samples per the FDA sample schedule, and the fee.
Under Act 851, a licence or permit (including importer/exporter licences) may be renewed for a period of not more than five years, and registration of premises likewise for not more than five years.
Importer company licences are renewed annually under the importation guideline (s.5.7).
On approval, the Authority allocates a registration number to the medical device for a period of not more than five years and issues a certificate of registration.
Statutory maximum; FDA may allocate a shorter period (fee schedule states device registration fees 'per annum').
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
A change of a registered premise must be notified to the Authority.
The Authority shall suspend or cancel a licence if information submitted in respect of the registration changes or is found to have been inaccurate; the applicant may re-submit new information after suspension or cancellation.
Any significant change that could reasonably affect safety, quality or performance of a registered device requires a variation application and the variation fee: changes to manufacturing process/facility/equipment, quality control procedures, design (including performance characteristics, specifications, software, accessories), and intended use (including contraindication changes and expiry-period changes).
What local class follows from which rules and decisive product facts?
Where a device can be classified into more than one class, the higher-risk class applies
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
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
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
Risk classes I through IV (FDA Ghana registration guidelines, GHTF/CMDR-style rules).
i
Class I
low
ii
Class II
medium
iii
Class III
high
iv
Class IV
highest
FDA Ghana
Which clinical or IVD performance evidence or study is required and accepted?
For clinical trials already approved by a well-resourced NRA, FDA may activate a reliance pathway case-by-case or at the applicant's explicit request; the applicant submits the full CTA plus the full assessment reports, identical to what was submitted to and approved by the reference NRA.
Effective from 2024-01-15
A decision to defer, approve or reject a clinical trial application must be taken within 60 working days for a routine application, 30 working days for an abridged evaluation after the reliance pathway is activated, and 21 working days for trials during emergency situations.
Effective from 2024-01-15
A person shall not conduct a clinical trial of a medical device (or drug, herbal medicinal product, cosmetic or procedure) without an approved valid certificate issued by the FDA; FDA is the final body authorising trials following Ethics Committee approval.
Is the product a device, IVD, accessory, software, or borderline product locally?
In vitro diagnostic medical device: a device intended by the manufacturer for in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes, including reagents, calibrators, control materials, specimen receptacles, software and instruments.
Medical device means an instrument, apparatus, implement, medical equipment, machine, contrivance, implant, in vitro reagent or similar article, including components and accessories, intended for diagnosis/cure/mitigation/treatment/prevention of disease or to affect body structure/function, not achieving principal intended purpose through chemical action or metabolism.
Definition modelled on US FD&C Act wording; covers human and veterinary use (s.1.0).
SaMD is software intended to be used for one or more medical purposes that performs those purposes without being part of a hardware medical device; it is a medical device and includes IVD software. Software intended to drive a hardware medical device is not SaMD. Mobile apps meeting the definition are SaMD.
Effective from 2017-12-01
IMDRF SaMD WG N10-based definition.
Which evidence, local deltas, formats, and signatures are required?
A certified copy is a true copy of the original certified by a person registered to practise law in the manufacturer's country of origin, endorsed with the legal practitioner's official stamp and signature.
All applications and supporting documents must be in English; non-English reports are not accepted alone. Non-English material must be submitted in the original language with a full English translation, authenticated at the nearest Ghana Embassy or by the National Drug Regulatory Authority of the country of origin.
The dossier must include Summary Technical Documentation demonstrating conformity to the Essential Principles of Safety and Performance, covering device verification and validation, biocompatibility, software validation, pre-clinical studies, clinical evidence (if applicable) and risk analysis.
Based on GHTF STED (GHTF/SG1/N011:2008); diagnostic test kits additionally require starting-material and finished-product process details (s.3.2.3).
A new registration application comprises one original hard copy and one electronic copy (text-selectable PDF on CD-ROM), samples of the product per the FDA sample schedule, and the non-refundable application fee per the FDA Fee Schedule.
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
An application for registration of a medical device can be made by a manufacturer or by an importer of the device; the applicant is responsible for the product and all issues relating to it.
The local agent must monitor the device on the market and inform the Authority of any relevant issue including serious manufacturing defects, facilitate communication between applicant and Authority, handle device recalls, and provide technical support and services to users.
A non-resident applicant must appoint a local agent: a corporate body registered in Ghana mandated by the applicant, evidenced by a power of attorney or equivalent documentation.
Which establishment licences, importer permissions, and distribution controls apply?
All importers of medical devices are required to renew their company licence with the FDA annually.
Only companies duly registered by the Registrar-General's Department and licensed by the FDA are permitted to import medical devices; the Medical Devices Department registers importers and reviews compliance with Good Distribution Practice (GDP) requirements.
Import permits must be granted before importation of a medical device; permits are presented to Customs (CEPS) once only and are valid for one calendar year from the date of issue. A processing fee is charged.
Only FDA-registered medical devices may be imported; imported products are inspected by FDA officials at the approved port of entry before release to the importer.
Imported medical devices must have at least 60% of shelf life remaining on arrival; products with shelf life under 24 months must have at least 80% remaining.
What regulator fee applies to this class, route, event, and date?
Registration application fees are non-refundable and are set per the FDA Fee Schedule; fees are prescribed by legislative instrument under s.147 of Act 851, and imported-device registration fees are denominated in USD collected as cedi equivalent ('Cedi Equivalent of USD$').
Non-refundability: guideline s.3.1.4.1 and Act 851 s.117(4); receipt-only-upon-payment: guideline s.3.1.7.1.
Which label and IFU elements, languages, symbols, and translation controls apply?
Device labelling must be in English, legible, permanent and prominent, and must include: proprietary and common name, manufacturer name and address, manufacturing site, device identifier, control number for Class III/IV devices (otherwise batch/lot number), contents indication, 'Sterile' and 'for single use only' where applicable, expiry date, intended uses, directions for use, warnings, precautions and special storage conditions.
Which current law, regulation, guidance, and transition provisions apply?
Public Health Act, 2012 (Act 851), Part 7 is the enabling legislation for medical device registration, import control, safety monitoring and enforcement in Ghana.
Guidelines issued in pursuance of s.148 of Act 851; Act published on FDA website.
Clinical trials in Ghana, including trials of medical devices, are regulated under Public Health Act 2012 (Act 851) Part 8, ss.150-166; current guideline FDA/CTD/GDL-ACT/2024/05 dated 15 January 2024.
Effective from 2024-01-15
Guideline for Registration of Medical Device, document FDA/MCH/MDD/GL-RMD/2013/01, version 02, date of issue 1 March 2016, is the current registration guideline posted by FDA Ghana.
Effective from 2016-03-01
Guideline for Registration of Software as a Medical Device, document FDA/MCH/MDD/GL-RSAMD/2017/03, version 01, issued 1 December 2017.
Effective from 2017-12-01
Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?
The manufacturer is required to demonstrate a system for post-market surveillance as part of the regulatory framework, alongside the QMS, technical documentation and declaration of conformity.
Which current form, portal, account, and submission package must be used?
FDA Ghana publishes distinct application forms for registration of Class I medical devices, Class II-IV medical devices, and licence as an importer of medical devices; applications are submitted by cover letter addressed to the Chief Executive Officer, FDA, P.O. Box CT 2783, Cantonment-Accra.
Which QMS, audit, inspection, and certificate scope is accepted or required?
For an application from a new manufacturing site, FDA will inspect the facility or use other means to verify compliance with cGMP regulations/guidelines before registration; no product is registered unless the facility complies with cGMP.
For all imported condoms, a mandatory foreign inspection of the manufacturing facility is conducted by FDA to ascertain cGMP/QMS compliance; the inspection fee is set in the Fees and Charges L.I.
Guideline cites L.I. 2228 (2016) for the foreign inspection fee; current posted schedule shows foreign GMP audit fees (see typed findings).
The manufacturer must demonstrate a functional quality management system (QMS), a system for post-market surveillance, technical documentation, and a declaration of conformity, plus registration of the manufacturing facility and the devices.
Which recall, FSCA, notice, and authority-coordination duties apply?
The local agent handles device recalls; the MDCHC Market Surveillance Department conducts post-registration market surveillance operations for medical devices, recalls, retail outlet inspections/raids, and detention of non-conforming goods.
Local agent recall duty: registration guideline s.3.1.3.3 'Handle device recalls.' FDA lists a 'Guidelines for Product Recall' on its services page.
Which registration, notification, listing, reliance, or conformity route applies?
FDA Ghana processes new, renewal and variation applications for Class I to IV medical devices; separate application forms exist for registration of Class I devices and Class II-IV devices.
Class I and Class II-IV application forms listed on FDA guidelines index page (res-gh-md-guidelines-index).
A separate application is required for each single medical device, or for a medical device group, medical device family or medical device system.
No person shall manufacture, prepare, import, export, distribute, sell, supply or exhibit for sale a medical device unless it has been registered by the Authority.
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.
Regulatory reference
Under the WHO Collaborative Registration Procedure, the aim is for participating NRAs to issue a regulatory decision within 90 working days; participation is voluntary for manufacturers and applicants must comply with both national and CRP requirements.
WHO page states 'within 90 working days' without the qualifier 'after access to all relevant information'.
Prior approval / evidence record
CE Mark (EU MDR)
Yes
A CE certificate is the technical dossier and QMS evidence behind a reliance submission, and supports a desk-review waiver of the QMS audit.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
The Medical Devices Department grants market authorisation for medical devices through the WHO collaborative registration procedure (CRP) for accelerated registration of WHO pre-qualified medical devices.
WHO CRP is voluntary for manufacturers and requires an NRA participation agreement; see res-who-crp.
Prior approval / evidence record
FDA 510(k)/PMA
Yes
Serves the same role as a CE certificate in a reliance submission.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
FDA Ghana grants market authorisation for medical devices using reliance on regulatory decisions of well-resourced National Regulatory Authorities, exchanging scientific assessments, safety data and inspection reports.
Prior approval / evidence record
Decision of another well-resourced national regulatory authority
Yes
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.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
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.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
ghana
all classes under the device registration guideline (full dossier review)
No Reliance Route
none
Product Marketing
Yes
Yes
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)
Yes
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.
Not quantified — the FDA calls the route accelerated without publishing a period
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
What review, validation, and applicant stop-clock rules apply?
For clinical trial applications, the official clock pauses upon issuance of queries and resumes on receipt of responses; applicants must address all queries within 6 months, failing which the application is treated as a new submission; failure to address outstanding issues within a year renders it null and void.
Effective from 2024-01-15
Applications are evaluated first-in-first-out (FIFO) unless expedited; expedited review applies to products for public health programmes (HIV/AIDS, Malaria, Tuberculosis, Reproductive Health, Neglected Tropical Diseases), paediatric programmes, Ministry of Health tender purposes, post-approval variations, and renewals of registration.
If responses to queries are not submitted within 12 months from the date the queries were issued, the applicant is considered to have withdrawn the application; registration may then only be considered upon a new application.
When a query is issued to the applicant through a deferral letter, the evaluation process stops until FDA receives a written response; the evaluation may only continue if responses to all queries in the same deferral letter are contained in one submission.
Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?
The registration prohibition does not apply to an FDA import permit for articles imported for personal use, and does not prevent importation of a sample for purposes of registration.
In an emergency occurring or believed imminent, a request for consideration for an EUA is expected to be acted upon within 15 working days; the applicant must appoint a Qualified Person for Pharmacovigilance (QPPV) as a condition.
Effective from 2021-02-05
EUA allows FDA to authorise either an unregistered medical product or an unapproved use of a registered medical product during a declared Public Health Emergency; it covers allopathic medicines, biological products including vaccines, and medical devices, when there are no adequate, approved and available alternatives.
Effective from 2021-02-05
An EUA terminates one year from the date of issuance of the authorisation letter or when the Public Health Emergency declaration ceases to exist, whichever is earlier.
Effective from 2021-02-05
Which standards, tests, and radio, electrical, metrology, or other overlays are triggered?
After registration, any imported condom consignment is detained, sampled and analysed on a batch-to-batch basis and released only if it passes quality evaluation at the FDA Medical Devices Laboratory.
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
In the event of rejection of a clinical trial application, the applicant may appeal to the Minister of Health within sixty days in writing, giving grounds for review; absent a representation within that period the Authority's decision stands.
Effective from 2024-01-15
Where the Authority refuses registration or approves it subject to conditions, the Chief Executive Officer shall inform the applicant in writing of the decision and the reasons within thirty days of the refusal or approval.
An applicant not satisfied with a registration decision may make representations to the Authority within sixty days after notification; if the Authority remains unsatisfied it shall reject the application.
Responses to all queries in a deferral letter must be provided in one submission; if queries are reissued a third time and responses remain unsatisfactory, the application is rejected.
An applicant may withdraw a registration application at any time, but withdrawal does not entitle the applicant to a refund of the application fees.
Which UDI, device listing, database, and traceability duties apply?
The Authority keeps separate registers for registration of regulated products including medical devices; the Medical Devices Department maintains the medical devices register.
What is reportable, by whom, where, in what format, and by what deadline?
The local representative for a regulated product shall monitor the safety of the product granted marketing approval and shall report an adverse effect or event to the Authority during the period for which the product is registered; the Authority continually monitors safety by analysing adverse effect/event reports.
ghana:medical-device
ghana
Risk classes I through IV (FDA Ghana registration guidelines, GHTF/CMDR-style rules).
i
Class I
low
ii
Class II
medium
iii
Class III
high
iv
Class IV
highest
FDA Ghana
official-source-verified
FDA Ghana — Guidelines for the Registration of Medical Devices, Section 3.3 and Appendix IV
https://fdaghana.gov.gh/guidelines-for-the-registration-of-medical-devices
2026-08-25
Ghana
ghana
GH
🇬🇭
Ghana Food and Drugs Authority
FDA Ghana
africa
3
4-class (A, B, C, D) — EU-aligned
device-registration
Medical-device registration (Class I-IV)
FDA Ghana registration
6
6
months
7
10
months
Yes
official-verified
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
https://fdaghana.gov.gh/fda-client-service-delivery-charter
2020-01-01
2026-08-30
registration-renewal
Registration renewal (Class I-IV)
FDA Ghana renewal
3
3
months
3
6
months
Yes
official-verified
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
https://fdaghana.gov.gh/fda-client-service-delivery-charter
2020-01-01
2026-08-30
minor-variation
Minor variation
FDA Ghana variation
3
3
months
3
5
months
No
official-verified
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
https://fdaghana.gov.gh/fda-client-service-delivery-charter
2020-01-01
2026-08-30
major-variation
Major variation
FDA Ghana variation
6
6
months
6
9
months
Yes
official-verified
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
https://fdaghana.gov.gh/fda-client-service-delivery-charter
2020-01-01
2026-08-30
foreign-facility-gmp-certificate
GMP certificate for a foreign manufacturing facility
FDA Ghana facility certification
3
3
months
3
6
months
Yes
official-verified
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
https://fdaghana.gov.gh/fda-client-service-delivery-charter
2020-01-01
2026-08-30
local-manufacturing-licence
Manufacturing licence for a local facility
FDA Ghana premises registration
4
4
weeks
1
3
months
Yes
official-verified
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
https://fdaghana.gov.gh/fda-client-service-delivery-charter
2020-01-01
2026-08-30
WHO prequalification (Collaborative Registration Procedure)
Yes
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.
Not quantified — the FDA calls the route accelerated without publishing a period
Decision of another well-resourced national regulatory authority
Yes
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.
None published
CE Mark (EU MDR)
Yes
A CE certificate is the technical dossier and QMS evidence behind a reliance submission, and supports a desk-review waiver of the QMS audit.
None published
FDA 510(k)/PMA
Yes
Serves the same role as a CE certificate in a reliance submission.
None published
Yes
Ghanaian Authorized Representative
No
Not accepted
Not published; the guideline fixes only the filing lead time, requiring renewal at least 3 months before the existing registration expires
2026-08-30
official-verified
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
https://fdaghana.gov.gh/fda-client-service-delivery-charter
2020-01-01
2026-08-30
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
https://fdaghana.gov.gh/guidelines-for-the-registration-of-medical-devices
2016-03-01
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 Ghana. Appoint a Ghanaian Authorized Representative.
1-3 months
📋
2
Application Submission
Submit complete registration dossier to FDA Ghana including device description, risk analysis, and testing reports.
1-2 weeks
📤
3
Administrative Review
FDA Ghana 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 Ghana may issue questions.
6 months
⚙️
5
Registration Approval
Upon successful review, FDA Ghana issues Ghana market authorization certificate.
1-2 weeks
✅
ghana
Ghana
GH
FDA Ghana
60
60
USD
Yes
160
160
USD
Yes
imported-registration-class-i
Imported product registration - Class I (low risk)
USD
60
USD 60
Per product, per annum
Payable in cedi equivalent.
exact-current
official-verified
https://fdaghana.gov.gh/img/appfees
Ghana FDA current fee schedule
2026-08-25
imported-registration-class-ii
Imported product registration - Class II (medium risk)
USD
100
USD 100
Per product, per annum
exact-current
official-verified
https://fdaghana.gov.gh/img/appfees
Ghana FDA current fee schedule
2026-08-25
imported-registration-class-iii-iv
Imported product registration - Class III/IV (high risk)
USD
160
USD 160
Per product, per annum
exact-current
official-verified
https://fdaghana.gov.gh/img/appfees
Ghana FDA current fee schedule
2026-08-25
local-registration-annual-fee
Locally manufactured product registration
GHS
250
GH¢ 250
Per product, per annum
exact-current
official-verified
https://fdaghana.gov.gh/img/appfees
Ghana FDA current fee schedule
2026-08-25
variation-foreign-major
Major variation - foreign products
USD
500
USD 500
Per variation
exact-current
official-verified
https://fdaghana.gov.gh/img/appfees
Ghana FDA current fee schedule
2026-08-25
variation-foreign-minor
Minor variation - foreign products
USD
300
USD 300
Per variation
exact-current
official-verified
https://fdaghana.gov.gh/img/appfees
Ghana FDA current fee schedule
2026-08-25
variation-local-major
Major variation - local products
GHS
200
GH¢ 200
Per variation
exact-current
official-verified
https://fdaghana.gov.gh/img/appfees
Ghana FDA current fee schedule
2026-08-25
variation-local-minor
Minor variation - local products
GHS
100
GH¢ 100
Per variation
exact-current
official-verified
https://fdaghana.gov.gh/img/appfees
Ghana FDA current fee schedule
2026-08-25
foreign-gmp-audit
Foreign GMP audit
USD
4000
4000
7500
USD 4,000–7,500
Per audit
USD 4,000 for sites in Africa; USD 7,500 outside Africa.
exact-current
official-verified
https://fdaghana.gov.gh/img/appfees
Ghana FDA current fee schedule
2026-08-25
local-facility-inspection
Local facility inspection
GHS
200
50
400
GH¢ 50–400
Per inspection
Tiered by facility size (GH¢ 400/200/100/50); free-zone facilities pay GH¢ 5,000.
exact-current
official-verified
https://fdaghana.gov.gh/img/appfees
Ghana FDA current fee schedule
2026-08-25
storage-inspection
Storage-facility inspection
GHS
240
120
800
GH¢ 120–800
Per inspection
exact-current
official-verified
https://fdaghana.gov.gh/img/appfees
Ghana FDA current fee schedule
2026-08-25
ivd-laboratory-analysis
IVD laboratory analysis
GHS
2500
GH¢ 2,500
Per analysis
exact-current
official-verified
https://fdaghana.gov.gh/img/appfees
Ghana FDA current fee schedule
2026-08-25
equipment-verification
Equipment verification
GHS
2000
GH¢ 2,000
Per verification
Re-analysis after failure: GH¢ 150 per sample.
exact-current
official-verified
https://fdaghana.gov.gh/img/appfees
Ghana FDA current fee schedule
2026-08-25
advertisement-approval
Advertisement approval
GHS
600
GH¢ 600
Per script, language and medium
Fast-track: GH¢ 1,800; airing an unapproved advertisement: GH¢ 25,000.
exact-current
official-verified
https://fdaghana.gov.gh/img/appfees
Ghana FDA current fee schedule
2026-08-25
2026-08-25
official-verified
Ghana FDA current fee schedule
https://fdaghana.gov.gh/img/appfees
2026-08-25
2026-08-25
exact-current
Yes
ghana
Ghana
low
fda-ghana-essential-principles-sted-evidence
FDA Ghana essential-principles STED evidence
Medical Electrical Safety
Included In Medical Registration
Finished Device
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.
reviewed
FDA Ghana
guidelines for the registration of medical devices — recognised standards, STED evidence
https://fdaghana.gov.gh/guidelines-for-the-registration-of-medical-devices
