Medical Device Classifier (Kenya)
Automatically classify devices into provisional Class A, B, C, or D using a structured risk questionnaire with rationale.
Quick Examples
Click any example to auto-fill the questionnaire, then run classification.
Device Risk Questionnaire
Start with name and intended use. The AI inference engine will estimate class from text, then you can refine with advanced fields if needed.
Step 2 - Run the classifier
"Let AI infer" answers are accepted - the classifier will use the device name and rules to fill the gaps.
AI-Generated Provisional Output
Complete questionnaire
Important Disclaimer
This tool gives a provisional risk class using structured logic for planning and dossier preparation. It is not a legal determination. Final classification and pathway are decided by the Pharmacy and Poisons Board (PPB) after full dossier review.
What is medical device classification in Kenya?
Medical device classification is the process of placing a device, or an in vitro diagnostic (IVD), into a risk class so the regulator knows how much scrutiny it needs before it can be imported, sold, or used. In Kenya, the Pharmacy and Poisons Board (PPB) regulates medical devices and IVDs using a risk-based system that runs from Class A (lowest risk) to Class D (highest risk). The framework follows the international IMDRF and GHTF principles that also underpin the East African Community harmonized guidelines, so a class assigned in Kenya usually maps cleanly onto neighboring markets such as Uganda and Tanzania.
The class is driven by intended use and a set of risk factors: how invasive the device is, how long it contacts the body, whether it is active (powered), implantable, sterile, has a measuring function, or incorporates a medicinal or biological action. For IVDs, the public-health stakes of a wrong result matter most, which is why assays used for blood screening or detecting transmissible agents sit at the top of the scale. Getting the class right early shapes everything that follows, from the registration fee band to the depth of technical evidence the PPB expects in your dossier.
This matters commercially because the class decides your route to market. A Class A surgical instrument and a Class D implantable both need PPB registration before importation, but the evidence package, review timelines, and cost differ substantially. A defensible, well-documented classification rationale protects you from rejections, re-submissions, and consignments held at the port of entry while a misclassification is resolved.
For a full breakdown of the four classes with examples and the PPB registration path, read our guide to medical device classes in Kenya.
How to use this device classifier
Describe the device
Enter the device or family name and a clear intended-use statement. The more specific the intended use (what it does, where it is used, and on whom), the more accurately the tool can infer risk.
Refine the risk factors
Open the advanced options to confirm invasiveness, duration of contact, whether the device is active, implantable, sterile, or an IVD. Leave any field as "Let AI infer" and the classifier will estimate it from your text.
Review and verify
Read the provisional Class A to D result, the triggers that drove it, and any review flags. Copy the summary for your dossier notes, then send it to our team for a free correctness check before you submit to the PPB.
Frequently Asked Questions
About medical device classification and this tool