Expanding your medical device business into Ghana requires a clear understanding of the country’s regulatory framework governed by the Ghana Food and Drugs Authority (FDA). 
Navigating this process can be complex — from product classification to dossier preparation, inspections, and approvals. 

That’s where OMC Medical comes in. 
As a trusted global regulatory consultancy, OMC Medical supports manufacturers and importers in obtaining Medical Device Marketing Authorizations in Ghana and across Africa. 
With expertise in technical documentation, ISO 13485 compliance, authorized representation, and post-market support, OMC ensures a smooth and efficient registration process for your devices. 

Step-by-Step Medical Device Registration Process in Ghana

Step 1: Classify Your Medical Device 

Medical devices in Ghana are regulated by the Food and Drugs Authority (FDA) under the Public Health Act, 2012 (Act 851). 

Classification follows a risk-based approach, similar to the IMDRF/EU model: 

• Class A: Low risk 

• Class B: Low–moderate risk 

• Class C: Moderate–high risk 

• Class D: High risk 

Correct classification determines the level of documentation, fees, and review complexity. 

Step 2: Appoint a Local Authorized Representative (Mandatory) 

Foreign manufacturers must appoint a Ghana-based Local Agent authorized to liaise with the FDA. 
The representative will: 

• Submit the registration dossier. 

• Act as the official communication channel with the Ghana FDA. 

• Hold the product’s marketing authorization certificate. 

• Manage post-market surveillance and reporting. 

Step 3: Prepare the Technical Dossier 

The dossier should comply with the Ghana FDA’s medical device registration requirements and demonstrate the safety, quality, and performance of the device. 

Key components include: 

1. Administrative Documents 

• ISO 13485:2016 Certificate for the manufacturing site. 
• Power of Attorney appointing the local representative. 
• Free Sale Certificate or Certificate to Foreign Government. 
• Certificate of Incorporation (manufacturer and local agent). 

2. Device Description and Intended Use 

• Product variants and accessories (if applicable). 
• Device description (model, design, and specifications). 

3. Labelling and Packaging 

• Device labelling compliant with Ghana FDA requirements. 

• Instructions for Use (IFU) in English. 

4. Evidence of Safety and Performance 

1. Risk Management File (ISO 14971). 

2. Biocompatibility and clinical evaluation reports (as applicable). 

3. Performance or functional test reports. 

5. Quality and Manufacturing Information 

1. Manufacturing process flowchart. 

2. Product specifications. 

3. Batch Certificate of Analysis (CoA). 

Step 4: Submission to the Ghana FDA 

The local representative will submit the complete application dossier and pay the prescribed fees to the Medical Devices Department of the Ghana FDA. 

Step 5: Ghana FDA Review and Evaluation 

The FDA conducts a thorough review of the technical dossier. 
If additional information or clarifications are required, the authority will notify the applicant. 
Review time varies based on device class and completeness of documentation. 

Step 6: Inspection or Audit (If Required) 

Depending on the risk classification, the FDA may inspect the manufacturing facility to verify compliance with Good Manufacturing Practices (GMP) and ISO 13485:2016 standards. 

Step 7: Grant of Marketing Authorization 

Upon satisfactory review and compliance with all requirements, the Ghana FDA issues a Medical Device Marketing Authorization Certificate. 
This authorization is typically valid for five (5) years and must be renewed before expiry. 

Key Considerations and Challenges 

• Lead Time: The complete process may take 6 to 12 months, depending on product class and documentation quality. 

• Language: All submissions must be in English. 

• Post-Market Obligations: 

• Report adverse events or product recalls. 

• Renew certificates before expiry. 

• Maintain updated technical documentation. 

• Fees: Costs vary depending on device classification and number of variants. 

Why Partner with OMC Medical Limited? 

When it comes to getting medical devices and IVDs (in vitro diagnostics) to market — especially in complex regulatory environments — you need a guide who knows the ropes. OMC Medical Limited is one such partner. Here’s what makes them stand out: 

Key Strengths & What You Get from OMC Medical 

What You Can Expect: Working with OMC Medical in Ghana 

If you’re registering a medical device in Ghana, OMC Medical can help you: 

• Classify the device, per Ghana FDA classes I-IV.  

• Prepare full technical documentation including risk analysis, verification & validation, evidence of conformity, biocompatibility etc.  

• Appoint the Authorized Representative in Ghana, who will be the point of contact with Ghana FDA. 

• Submit on your behalf, interact with regulatory authority queries, manage follow-ups. 

• Ensure your regulatory strategy is efficient, minimize delays, avoid issues due to incomplete documentation. 

Conclusion 

Registering a medical device in Ghana requires careful preparation and adherence to the Ghana FDA’s regulatory framework. 
To streamline your approval, it is highly recommended to work with an experienced local representative or regulatory consultant familiar with the FDA’s procedures and technical dossier expectations.