Kenya Medical Device Risk Classification A, B, C and D: Rules, Fees and Rationale

Content verified as of October 30, 2026

1. Key takeaways

• Kenya applies a four-tier risk classification of Class A, B, C and D, consistent with the GHTF/IMDRF classification framework. Classification is determined by the manufacturer based on intended use; PPB verifies the rationale during review rather than assigning the class on the applicant’s behalf.
• Where multiple rules apply simultaneously, the highest applicable class governs. This is a conflict-resolution rule set out expressly in the rules, not a conservative preference.
• Classification directly determines fees: for imported products, Class A is USD 100, Class B is USD 200, and Class C and Class D are each USD 1,000.
• The classification rationale must be written into the Common Submission Dossier Template (CSDT) and mapped to each selected rule item by item. A classification that states only a conclusion without the reasoning will be sent back for correction.
• A change in risk classification is one of five situations that require submission of a new CSDT. A misclassification cannot be fixed with an explanatory letter.

2. Legal basis

3. Expert insights

Insight 1: The classification power and the burden of proof both sit with the manufacturer

The PPB guidelines hand the classification power to the manufacturer while leaving the burden of proof on the same side: the device identification module of the CSDT requires the classification rationale to be stated and mapped to each selected rule. The practical reason for this design is review capacity. PPB cannot redo the classification exercise for every submission; it can only verify whether the manufacturer’s reasoning is internally coherent. The most common mistake companies make is transplanting conclusions from other jurisdictions. There is no statutory mapping between an EU Class IIa device and a Kenyan Class B device. Once transplanted, a single query from PPB exposes the fact that the local rule-by-rule analysis was never performed.

Insight 2: Taking the highest class is a conflict rule, not an attitude of prudence

The classification rules are laid out in parallel across risk dimensions: duration of contact, degree of invasiveness, whether the device administers medicines or energy to the patient, whether it has biological effects, and local versus systemic effects. The same device may fall into different classes under different dimensions, and the rules offer no weighted average, only the highest result. Add the seven special categories (drug-device combinations, animal-origin materials, disinfection and sterilization devices, devices containing cells or tissues, ophthalmic solutions, contraceptive or sexually transmitted disease prevention devices, and long-term implants), and the outcome is often pushed upward overall. The typical error GRZAN observes is fixing the class first and then hunting for rules to support it. The correct sequence is to walk through every rule, record the conclusion for each, and then take the highest.

Insight 3: Classification is the master switch for fees, routes and dossier depth

On fees, Class A and Class C/D differ by a factor of ten (USD 100 versus USD 1,000). On routes, Class A requires only listing; Class B may use the abridged route backed by approvals from at least 2 reference regulatory agencies (RRAs), while Class C/D requires at least 3. On dossier depth, the common submission set for Class B/C/D contains 12 items, clearly deeper than the 9 items required for Class A listing. Classification is therefore never an isolated technical conclusion; it is simultaneously a budget conclusion and a scheduling conclusion.

Insight 4: The price of misclassification is starting over, not correction

The guidelines list a change in risk classification among the five situations that require submission of a new CSDT, alongside changes in intended use, changes in device grouping, changes in the medicinal substance of drug-device combinations, and listing across a proprietary name family. If a change notification is misclassified, the application will be rejected and continued supply prohibited. Drug-device combinations must first be assessed for the Primary Mode of Action (PMOA): devices whose primary action is not achieved through pharmacological, immunological or metabolic means are regulated as devices, while devices containing a registrable medicine are always Class D, reviewed jointly by the medical devices directorate and the biologics and human medicines directorate. Running one full classification exercise before submission costs far less than one corrective exercise after launch.

4. Practical recommendations

1. Build a classification worksheet. List each applicable rule, the class concluded under that rule, the final highest class and the reasoning, and archive it as a CSDT annex.
2. Start from intended use, not from product form. The same physical configuration can fall into different classes under different intended uses.
3. Assess PMOA first for drug-device combinations. Any combination containing a registrable medicine should be prepared as Class D with joint review documentation.
4. Walk every model in a family through the rules. Do not classify the family as a whole; avoid leaving individual models exposed to higher-class rules.
5. Align the statement in three places. The classification conclusion must be consistent across the label, the instructions for use and the declaration of conformity.
6. Query boundary products in writing in advance. Write to the PPB medical devices directorate (medicaldevices@pharmacyboardkenya.org) and retain the reply.

5. Verification checklist

• □ Has every classification rule been walked through with the reasoning record retained?
• □ Where multiple rules are triggered, has the highest class been taken?
• □ Is the classification conclusion consistent with the label, the IFU and the declaration of conformity?
• □ For drug-device combinations, has the PMOA assessment been completed and Class D confirmed or excluded?
• □ Has each model in a product family been classified individually rather than as a family?
• □ Has the fee tier (USD 100/200/1,000) and the annual retention amount been confirmed against the class?
• □ Has the submission route and dossier depth (9-item listing or 12-item common set) been confirmed against the class?
• □ For boundary products, has a written reply from PPB been obtained, or has the rationale been documented in the dossier?

Regulatory information verified as of October 30, 2026.

Across African markets, the GRZAN regulatory team focuses on jurisdictions including Kenya, Nigeria, South Africa and Egypt, and operates a verification mechanism built on primary regulatory sources: every regulatory conclusion published externally rests solely on official gazettes, the original text of competent authority guidelines and public legal databases, each marked with its verification date. Any figure, timeline or amount that cannot be located in an official source is labeled as a practical estimate and never presented as an assumption.

GRZAN services cover market access strategy and risk classification assessment; preparation and review of registration dossiers in CSDT, STED and CTD formats; selection and management of Local Authorized Representatives (LAR); quality management system and GMP/GSDP compliance support; post-market vigilance, change management and recall response; import customs clearance and PVoC coordination; and regulatory intelligence subscription with corporate compliance record-keeping.

For a Kenya market access plan tailored to your specific product, contact the GRZAN regulatory team at info@grzanglobal.com.