Regulatory Strategy
Tailored pathways to approval
- Risk classification & regulatory pathways
- Labeling and IFU localization
- Technical dossier development
- Ghana FDA roadmap planning
Trusted Ghana FDA partner for global innovators
Navigating Medical Device Registration in Ghana Just Got Easier
Regnova is your on-the-ground partner for Ghana FDA approvals, compliant distribution, and ongoing post-market surveillance across West Africa.
Local regulatory strategists & clinical partners60+ Ghana FDA approvals & renewals
Ghana FDA Registration
Local clinical expertise meeting global regulatory standards.
About Regnova
Local expertise, global medical device reach
Regnova is a Ghana-based medical device distributor and regulatory partner.
We help in navigating complaints, submitting summaries, obtaining Ghana FDA clearance, and maintaining ongoing compliance.
Services
Comprehensive regulatory support for Ghana market success
Navigate approvals, distribution, and compliance with a Ghana-based partner dedicated to accelerating safe access to medical innovations.
Product Registration
From submission to certificate
- Application compilation and filing
- Authority correspondence
- Certificate tracking
- Renewals & variations
Distribution & Logistics
Get your product to market faster
- Customs clearance and product release
- Cold-chain & warehousing
- Hospital & clinic delivery
- MOH channel coordination
Post-Market Surveillance
Protect your patients, brand, and license
- Complaint & adverse event portals
- Recall tracking & readiness
- Regulatory reporting support
- PMS analytics dashboards
Partner Enablement
Equip your local teams for scale
- Supplier qualification
- Quality systems advisory
- SOP development
- Local onboarding
Regulatory Intelligence
Continuous insight for market expansion
- Market access research
- Policy monitoring
- Competitive benchmarking
- Risk mitigation insights
How It Works
A structured path from concept to compliant distribution
Follow a clear three-phase engagement designed for global manufacturers entering Ghana’s healthcare market.
01Discovery call
We align on device scope, indications, and launch timelines. Gap assessment ensures requirements are clear from day one.
02Regulatory submission
Our team compiles dossiers, files with Ghana FDA, and manages authority feedback through approval.
03Launch & monitor
We coordinate importation, training, and post-market surveillance to keep devices compliant in-market.
Ready to launch?
Turn compliance into a competitive advantage
Our Ghana-based team blends regulatory expertise, clinical insight, and logistics execution so you can focus on expanding access to life-changing medical devices.
Copyright © 2025 Regnova — Medical Device Registration, Distribution & PMS in Ghana.
Privacy policy