Get your device registered for East Africa
We handle regulatory representation, product registration, and compliance so your medical device or IVD reaches Kenya and East Africa without the guesswork.
Most firms chase approvals. We chase the market.
We act as your Local Representative or Market Authorization Holder (MAH), a role many overlook until a submission stalls.
Engagement options and support scope
No two product portfolios line up the same. We shape the engagement to your registration roadmap, not the other way around.
Representation only
Custom
QuoteFor teams that handle submissions internally but need a registered Local Representative or MAH in country.
MAH appointment
License maintenance
PPB liaison
Renewal reminders
Full registration
Custom
QuoteFrom dossier prep to PPB submission, we manage the entire registration for one or multiple products.
Dossier preparation
PPB submission
Kickoff roadmap
Regulatory representation
Status reporting
End-to-end support
Custom
QuoteA retained compliance partner across East Africa, covering registration, post-market obligations, and renewals.
Everything in full
Post-market compliance
Vigilance handling
Renewal management
UDI support
Trusted by Regulatory Professionals
Our clients achieve streamlined regulatory approvals and market access across East Africa. Specialized consulting bridging compliance gaps and accelerating timelines.
Our Class B registration in Kenya moved forward without a single request for resubmission.
Amara Osei
Regulatory Affairs Manager, IVD Manufacturer
Getting approval in Uganda took less time than we budgeted, thanks to their multi-country approach.
David Lindqvist
VP of Operations, Medical Device Company
They filled a gap we couldn't cover internally and our PPB submission went through on the first pass.
Priya Sharma
Quality Director, Startup Medical Device Firm
Their regulatory representation gave us a compliant path to East Africa we didn't have before.
Michael Brown
Head of International Sales, Established Manufacturer
A post-market compliance question was answered quickly and kept our renewal on track.
Elena Petrova
Compliance Lead, Medical Diagnostics Company
PPB registration questions, answered
Browse answers to common PPB registration questions, or reach out for personalized guidance.
You'll need your device's technical documentation, quality management system certificates, and labeling. We review your existing dossier first, then tell you exactly what's missing before any submission begins.
Ready to bring your device to East Africa?
Tell us where you're headed and what you're submitting. We'll reply with a clear scope and quote, usually within one business day.