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FDA Ghana · Middle East & Africa

Ghana medical device regulatory resources

Every Ghana dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

5 free resources24/25 topics with recordsAug 2026 fees reviewed
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Medical device regulation news

Follow recent Food and Drugs Authority Ghana policy, guidance, safety, and compliance updates.

Registration timeline

Compare official and realistic FDA Ghana approval times by device class and pathway.

AI medical device classifier

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Government registration fees

Review current FDA Ghana application, review, and renewal fees.

Structured regulatory requirements

Explore all 69 source-linked facts →

24 of 25 research dimensions currently covered · 13 official sources · latest verification 2026-09-15

Market entry

D01

Authority & regime

Verified
Competent authority
The Food and Drugs Authority (FDA) Ghana is the competent authority for medical devices; the Medical Devices Department processes and grants market authorisation for medical devices intende…
Devices department structure
The Medical Devices Department maintains the medical devices register, issues and revokes registration certificates, registers importers of medical devices, and has separate Low Risk and Hi…
3 source-linked facts
Checked 2026-08-26
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D02

Legal basis & guidance

Verified
Primary legislation
Public Health Act, 2012 (Act 851), Part 7 is the enabling legislation for medical device registration, import control, safety monitoring and enforcement in Ghana.
Clinical trial legal basis
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 Ja…
4 source-linked facts
Checked 2026-08-26
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D03

Device definition & scope

Verified
IVD definition
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…
Medical device definition
Medical device means an instrument, apparatus, implement, medical equipment, machine, contrivance, implant, in vitro reagent or similar article, including components and accessories, intend…
3 source-linked facts
Checked 2026-08-26
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D04

Classification rules

Verified
Risk classes I through IV (FDA Ghana registration guidelines, GHTF/CMDR-style rules).
Class I, Class II, Class III, Class IV
1 maintained scheme · 5 related facts
Checked 2026-08-25
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D05

Registration pathways

Verified
Registration routes
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.
One application per device grouping
A separate application is required for each single medical device, or for a medical device group, medical device family or medical device system.
3 source-linked facts
Checked 2026-08-26
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D06

Reliance & recognition

Verified
China NMPA approval: no recognition regime
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 descriptio…
Reliance on other NRAs
FDA Ghana grants market authorisation for medical devices using reliance on regulatory decisions of well resourced National Regulatory Authorities, exchanging scientific assessments, safety…
4 source-linked facts
Checked 2026-09-15
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D07

Economic-operator roles

Verified
Applicant
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.
Local agent duties
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…
3 source-linked facts
Checked 2026-08-26
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D08

Establishment, import & distribution

Verified
Annual importer licence renewal
All importers of medical devices are required to renew their company licence with the FDA annually.
Importer licensing
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…
5 source-linked facts
Checked 2026-08-26
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D09

Dossier requirements

Verified
Certified copy requirement
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 sta…
Language and translation rules
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…
4 source-linked facts
Checked 2026-08-26
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D10

Official forms & portals

Verified
Official application forms
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 subm…
1 source-linked fact
Checked 2026-08-26
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Submission & evidence

D11

Label, IFU & language

Verified
Labelling language and elements
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, c…
1 source-linked fact
Checked 2026-08-26
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D12

QMS, audit & inspection

Verified
cGMP inspection prerequisite
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 r…
Mandatory foreign inspection for condoms
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 Charge…
3 source-linked facts
Checked 2026-08-26
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D13

Standards, testing & ancillary approvals

Unresolved
FDA Ghana essential-principles STED evidence
Electrical safety
1 maintained overlay · 1 related fact
Checked 2026-08-26
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D14

Fees

Verified
Imported product registration - Class I (low risk)
USD 60
Imported product registration - Class II (medium risk)
USD 100
14 maintained fee lines · 1 related fact
Checked 2026-08-26
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D15

Review clocks

Verified
Medical-device registration (Class I-IV) · FDA Ghana registration
6 months
Registration renewal (Class I-IV) · FDA Ghana renewal
3 months
Minor variation · FDA Ghana variation
3 months
6 maintained pathways · 4 related facts
Checked 2026-08-30
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D16

Approval validity & renewal

Verified
Renewal lead time
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…
Licence and permit validity cap
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 fi…
3 source-linked facts
Checked 2026-08-26
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Lifecycle & post-market

D17

Change control

Verified
Premises change notification
A change of a registered premise must be notified to the Authority.
Duty to update; suspension for changed/inaccurate info
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 informat…
3 source-linked facts
Checked 2026-08-26
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D18

UDI, listing & traceability

Verified
Device register
The Authority keeps separate registers for registration of regulated products including medical devices; the Medical Devices Department maintains the medical devices register.
1 source-linked fact
Checked 2026-08-26
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D19

Clinical investigation & performance

Verified
CTA reliance pathway
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 plu…
Clinical trial decision timelines
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 reli…
3 source-linked facts
Checked 2026-08-26
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D20

Special access & derogation

Verified
Personal-use import and registration samples
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.
EUA processing target
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…
4 source-linked facts
Checked 2026-08-26
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D21

Manufacturer PMS

Verified
Post-market surveillance system
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 conformi…
1 source-linked fact
Checked 2026-08-26
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D22

Vigilance & incident reporting

Verified
Adverse event reporting by local representative
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 p…
1 source-linked fact
Checked 2026-08-26
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D23

Recall, FSCA & market surveillance

Verified
Recall responsibility and market surveillance
The local agent handles device recalls; the MDCHC Market Surveillance Department conducts post registration market surveillance operations for medical devices, recalls, retail outlet inspec…
1 source-linked fact
Checked 2026-08-26
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D24

Advertising, claims & promotion

Verified
Advertisement approval requirement
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 bee…
Fifth Schedule advertising ban
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.
2 source-linked facts
Checked 2026-08-26
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D25

Submission communications & appeal

Verified
Clinical trial appeal
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 representatio…
Decision notice period
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 thirt…
5 source-linked facts
Checked 2026-08-26
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Government fees

Full fee schedule (14 lines) →

FDA Ghana registration fees in USD · reviewed 2026-08-25

Fee lineAmountProvenance
Imported product registration - Class I (low risk)USD 60Verified
Imported product registration - Class II (medium risk)USD 100Verified
Imported product registration - Class III/IV (high risk)USD 160Verified
Locally manufactured product registrationGH¢ 250Verified
10 more fee lines on the full schedule · 14 of 14 rows source-verified

Registration timeline

Full registration timeline →

Ghana Food and Drugs Authority (FDA Ghana) review clocks and planning ranges · 4-class (A, B, C, D) — EU-aligned classification

Class / pathwayReview clockPlanning totalProvenance
Medical-device registration (Class I-IV)(FDA Ghana registration)6 months7-10 monthsVerified
Registration renewal (Class I-IV)(FDA Ghana renewal)3 months3-6 monthsVerified
Minor variation(FDA Ghana variation)3 months3-5 monthsVerified
Major variation(FDA Ghana variation)6 months6-9 monthsVerified
2 more pathways on the full timeline · 6 of 6 clocks source-linked
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(6 months)
  5. 5Registration Approval(1-2 weeks)
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