I. Dossier Format and CSDT Requirements
The Pharmacy and Poisons Board (PPB) of Kenya requires all medical device registration dossiers to be submitted in the Common Submission Dossier Template (CSDT) format, which is aligned with the IMDRF STED framework.
The dossier must include, at a minimum:
- Administrative information
- Manufacturer information
- Design verification and validation documentation
- Risk analysis
- Clinical evaluation report
- Post-market surveillance (PMS) plan
- Biocompatibility data (if applicable)
- Sterilization validation report (if applicable)
Applications not submitted in compliance with the CSDT format may be returned or subject to delayed review.
II. Core Responsibilities of the Local Authorized Representative (LAR)
Foreign manufacturers are required to appoint a Local Authorized Representative (LAR) established in Kenya. The LAR bears legal responsibility throughout the entire product lifecycle, including:
- Acting as the primary point of contact with the PPB
- Maintaining technical documentation for regulatory inspection
- Reporting adverse events and incidents
- Ensuring supply chain compliance
- Implementing Field Safety Corrective Actions (FSCA)
- Assisting with the submission of variation notifications
A single medical device may not appoint more than one LAR. Multiple LAR designations for the same product will render the registration invalid.
III. Classification Rules and Handling of Multiple Classification Criteria
Medical device classification is determined by the manufacturer based on the intended use and risk characteristics of the device. Where multiple classification rules apply, the device shall be classified according to the highest risk class.
For example, a device that is both invasive and incorporates a drug delivery function is typically classified as Class D.
Once determined, the classification must be clearly justified and documented in the registration dossier.
IV. Eligibility Criteria for Expedited and Instant Registration
Kenya offers an Instant Registration (IBR) pathway for Class B medical devices, subject to strict eligibility requirements:
- Approval by at least three reference regulatory authorities (e.g., FDA, CE-marked jurisdictions, TGA)
- Commercially marketed in at least two countries for a minimum of four years
- No records of death, serious health deterioration, or unresolved recalls within the past three years
- No history of rejection, suspension, or withdrawal by any regulatory authority due to quality or safety concerns
Eligible applicants may complete registration within one hour of online submission, significantly reducing time to market.
V. Classification and Approval of Post-Approval Changes
Any change that may impact the safety, quality, or performance of a medical device must be notified to the PPB:
- Technical changes (Class C/D devices): Prior approval required
- Reviewable changes (Class A/B devices): Prior approval required for changes such as expanded indications, additional models, or revisions to warnings
- Notification-only changes: Changes such as non-safety-related labeling text updates may be implemented upon notification
Incorrect classification of changes may result in suspension or cancellation of the registration.
VI. Post-Market Surveillance and Annual Retention
Following registration, companies must establish and maintain a Post-Market Surveillance (PMS) system to collect and evaluate safety and performance data.
In addition, an annual retention fee must be paid at least 60 days prior to the expiry date. Failure to comply may lead to suspension or cancellation of the registration.
VII. Labeling and Instructions for Use (IFU) Compliance
- Labels must include the manufacturer’s name and address, batch or lot number, expiry date (if applicable), and intended use
- Instructions for use must clearly describe operating procedures, warnings, and contraindications
- For software-containing devices, software lifecycle documentation and validation reports are required
If you require professional regulatory support or advisory services during the registration process, please feel free to contact us.