End-to-end compliance support across markets
We guide your submission through every regulatory checkpoint—from dossier preparation through post-market compliance. Our coverage spans FDA, EU MDR, and East African pathways, so you move forward with confidence at each stage.
Dossier Strategy & Preparation
We review your technical file, identify gaps, and map the submission pathway specific to your target market. This upfront read accelerates timelines and reduces revision cycles.
Regulatory Submission & Liaison
From FDA 510(k) to Kenya PPB registration, we prepare and submit your complete dossier, then manage all agency correspondence and requests for additional information until approval.
Post-Market Compliance & UDI
After approval, we keep you compliant with ongoing reporting, adverse event management, and unique device identification requirements across all your registered markets.
East Africa market entry, without the regulatory guesswork
JATESA guides medical device and IVD companies through Kenya PPB and East African regulatory pathways, from first dossier to full compliance.
We act as your Local Representative or Market Authorization Holder, so you meet regional requirements without a local office.
15 years of East African regulatory experience
We've handled submissions across multiple jurisdictions, so your path to the Kenya PPB is built on proven process.
15+
Years of expertise
Proven experience navigating complex East African regulatory landscapes.
1
Point of contact
A single dedicated expert guiding you through every step.
6
Core service areas
Comprehensive support across all key regulatory functions.
3
Regional markets
In-depth knowledge of multiple East African jurisdictions.
Trusted by global manufacturers.
JATESA's expert guidance helps medical device and IVD firms navigate complex regulatory compliance and market entry with confidence.
Registration questions, answered
Browse answers to common registration questions or reach out for additional help.
We prepare and submit your dossier to the Kenya PPB, then manage the review and any follow-up requests. You get a clear pathway from submission to market authorization, and we handle the administrative back-and-forth for you.
Ready to clear your first regulatory hurdle?
Book a consultation and we'll map your registration path with the PPB from dossier to approval.