Resources
Tools, guides, and templates to streamline your Ghana FDA journey.
Access RegNova’s curated library of compliance resources — built from real-world submissions, approvals, and post-market operations in Ghana.
Core Guides & Templates
Open each guide to see what’s included. Drop in your team’s contact details to request download access when ready.
1Importer License Guide+
What it is: A step-by-step walkthrough of how to obtain and maintain a Ghana FDA importer license.
What’s inside:
- License categories and eligibility requirements
- Documentation checklist
- Submission process and timelines
- Renewal process and ongoing obligations
- Common pitfalls and how to avoid them
2PMS SOP Pack (Post-Market Surveillance)+
What it is: A ready-to-use set of SOPs to meet Ghana FDA vigilance requirements and global best practices.
Includes:
- Complaint Handling SOP
- Adverse Event Reporting SOP
- Recall Management SOP
- Monthly PMS Reporting Template
- CAPA Workflow Template
3Labeling & UDI Checklist+
What it is: A practical guide to ensuring your device labeling meets Ghana FDA standards and international UDI rules.
Includes:
- Local language and content requirements
- Font size and placement guidelines
- Packaging and IFU alignment tips
- UDI data mapping template
Supplementary Resources
- Ghana FDA Device Classification Guide – Determine your device’s class before submission.
- Market Access Checklist – All steps from pre-submission through post-launch compliance.
RegNova Post-Market Surveillance Portal
The RegNova Post-Market Surveillance (PMS) Portal is a centralized digital platform for reporting, tracking, and responding to issues related to medical devices distributed in Ghana. Designed in compliance with Ghana FDA regulations, the portal ensures continued safety and performance monitoring after market entry.
Visit PortalPlaceholder visual: Dashboard mock-up or screenshot of the PMS portal interface. Recommended size 1200×900px.
Frequently Asked Questions (FAQs)
How long does it take to get Ghana FDA clearance?+
A typical Class II medical device application takes 3-6 months if all documents are complete.
Does RegNova handle customs clearance?+
Yes, we manage end-to-end importation including FDA release, customs, and delivery.
Can RegNova serve as our Local Representative in Ghana?+
Yes. RegNova is fully licensed to serve as a Local Authorized Representative for foreign manufacturers.
What documents are needed to begin registration?+
An IFU, device labels, CE or FDA certificate (if applicable), and a completed application form are required.
News from Our Product Lines
Stay up to date with new products, regulatory milestones, and field performance updates from our partners.
- Eko Sensora™ Stethoscope: Now in pilot use at 4 district hospitals
- AliveCor Kardia 12L: Cleared for commercial use in Ghana – August 2025
- EchoNous Kosmos POCUS: Class II registration completed; distribution begins Q4
- Upcoming Launch: AI-enabled screening bundle (Stethoscope + POCUS + ECG)
Helpful Links
- 1. Ghana FDA🌐 https://fdaghana.gov.gh
- 2. Ministry of Health Ghana🌐 https://moh.gov.gh
- 3. Ghana Standards Authority (GSA)🌐 https://gsa.gov.gh
Learn More
Connect with RegNova’s regulatory specialists
Book a discovery session to review your portfolio, understand Ghana FDA timelines, and unlock the full library of importer guides, PMS templates, and post-market resources.