Kenya is one of African major countries who have established a regulatory framework for medical devices. The country performs all the core regulatory activities including- licensing of establishments, registration of products, regulatory inspection, clinical trial oversight and other regulatory functions recommended by the Global Model Regulatory Framework for Medical devices including In vitro diagnostic devices- by the World Health Organization (WHO). This post provides the detailed information on the medical device registration process in Kenya by Pharmacy and Poisons Board.
Country Profile
Geographical Location: Kenya is located in East Africa, bordered by Ethiopia to the north, Somalia to the east, Tanzania to the south, Uganda to the west, and South Sudan to the northwest. The country has a coastline along the Indian Ocean to the southeast.
Language(s): The official languages of Kenya are English and Swahili, with various indigenous languages also spoken across different regions.
Population Size: As of the latest estimates (January 2025), Kenya has a population of approximately 54 million people.
Flag: The Kenyan flag consists of four colors: black, red, green, and white. It features three horizontal stripes: black on top, red (with white borders) in the middle, and green at the bottom. At the center, there is a Maasai shield with two white crossed spears, symbolizing defense and heritage.
Overview of Medical Device Regulation in Kenya
National Regulatory Authority (NRA):
The Pharmacy and Poisons Board (PPB) is the National Regulatory Authority (NRA) responsible for regulating medical devices in Kenya. Established under the Pharmacy and Poisons Act (Cap 244) in 1957, the PPB oversees pharmaceuticals, medical devices, and related healthcare products.
Main regulatory documents for medical device regulation
The PPB has published and is implementing some key documents that are used in regulatory oversight of the medical devices and IVDs. They include:
Health Act 2017 Chapter 241
Part VII of this Act provides conditions of establishment of a single regulatory body and its regulatory activities (functions) to control the marketing and use of health products and health technologies including medical devices and IVDs in Kenya. This Act restricts manufacturing, importing, distribution or marketing of any medical device in Kenya without obtaining marketing approval from the established regulatory body (i.e. PPB). The approval involves prior assessment of such products based on supplementary regulatory documents.
Guidelines for Registration of Medical Devices Including In-Vitro Diagnostics
This document was published in January 2022 and contains the following core information that manufacturers must understand prior to submitting their application for registering their products:
- Existing assessment and approval pathways
- Risk classification principles and rules for both Non-IVDs and IVDs.
- Documents required for registration of medical devices
- Reference regulatory authorities or trusted organizations on which PPB may rely to expedite its assessment and approval processes.
- Essential principles of safety and performance for both Non-IVDs and IVDs.
Note- PPB also has developed and started implementing other guidelines for post-registration changes approval, registration products during public health emergencies and others.
Medical device definitions
The definition for Medical devices follows the latest harmonized versions of the definitions initially established by the IMDRF and currently being used by almost all NRAs around the world. A medical device includes any instrument, apparatus, machine, software, or other article intended for medical use in diagnosis, prevention, monitoring, treatment, or alleviation of disease. A separate definition for In vitro diagnostic medical devices is also provided.
Classification System
The Pharmacy and Poison Board classifies medical devices based on their risk levels, using a system similar to the IMDRF model. Similar with the principles recommended by the IMDRF, the PPB’s classification system also depends on factors such as- intended use, intended users, degree of invasiveness, whether it contains medicinal products, duration of contact, site of contact, etc. Based on these factors, medical devices are classified by the PPB in Kenya into four classes (Class A, B, C & D).
| Class | Risk Level | Examples |
| A | Low | Bandages, hospital beds |
| B | Low-moderate | Urinary catheters, dental prosthetics |
| C | Moderate-high | Contact lenses for long-term use, stents with sealed radioisotopes |
| D | High | Pacemakers, implantable defibrillators, heart valves |
The complexity of regulatory requirements and assessment timelines increase as the risk level increases. PPB has different approval pathways for Class A, B and C&D devices.
Regulatory Approach/Model Used
Kenya follows a risk-based approach to medical device regulation, with increased scrutiny for higher-risk devices. The system is aligned with global best practices and leverages reliance on approvals from stringent regulatory authorities (SRAs) such as the US FDA, EU MDR, and WHO Prequalification.
Registration Application Requirements and Processing
Section 2.2. of the ‘Guidelines for Registration of Medical Devices including In-Vitro Diagnostics’ provides the detailed requirements of medical devices registration. The template is called- Common Submission Dossier Template (CSDT) and it is consistent with the Global Harmonization Task Force’s (GHTF’s) Summary Technical Documentation (STED) format.
All devices must be appropriately grouped/bundled into one or more of the following grouping options:
- a SINGLE medical device;
- one medical device FAMILY;
- one medical device SYSTEM;
- one medical device GROUP;
- one dental grouping term (DGT).
That means- devices which do not have similarities in technology, proprietary name, risk class and that do not work together to achieve one medical purpose have no less or no possibility of being bundled in one group to be submitted in one registration application. This leads to rejection of applications after waiting a lengthy queue for assessment and loss of regulatory service fees made to process each application. Therefore, due diligence should be done before submitting applications containing various devices or components.
All applications pass through the following processes
- Preparation and compilation of the documents required based on the device’s risk class and applicable evaluation pathway.
- Submission of the documents through PPB online portal (https://prims.pharmacyboardkenya.org/).
- Review of the application
- Regulatory outcome or issuance of registration certificate. Note– this final decision on registration may involve other regulatory activities if applicable (e.g. Lab test and/or onsite audit of manufacturing facility) in addition to dossier review.
Registration of Class A Medical devices
The following documents are required to register class A medical devices with Kenya’s PPB:
- Letter of Authorization
- Device labeling including label and instruction for use
- Certificate of Analysis
- Information on sterilization method(s) and its validations (if applicable)
- Regulatory approval from the product’s country of origin
- QMS Conformance certificate (ISO 13485 or equivalent)
Registration of Class B, C and D Medical devices
Kenya offers several regulatory pathways depending on the device’s risk classification and approval status in other markets:
- Full Evaluation Route: Required for devices without prior approvals from reference regulatory agencies.
- Abridged Evaluation Route: Available for devices approved by at least two reference regulatory agencies.
- Expedited Registration Routes:
- Expedited Class B Registration (EBR): Requires approval from at least two reference regulatory agencies with three years of market history with no global safety issues OR (approval from at least three of the reference agencies).
- Immediate Class B Registration (IBR): Requires approval from at least three reference regulatory agencies and four years of market history with no global safety issues.
- Expedited Class C/D Registration (ECR/EDR): Available for high-risk devices with at least three reference agency approvals.
Timelines for Registration
| Application Route | Expected Timeline |
|---|---|
| Full Evaluation | 6-12 months |
| Abridged Evaluation | 3-6 months |
| Expedited Route | 1-3 months |
| Immediate Registration (IBR) | Within 48 hours |
Please note that– This is just an estimation for review of submitted applications. Sometimes applications may be reviewed faster or slower than the timelines provided in this table.
PPB’s Reference Regulatory Agencies
- Therapeutics Goods Administration (TGA), Australia
- US Food and Drug Authority (US FDA)
- Health Canada, Canada
- European Union
- Ministry of Health, Labour and Welfare (MHLW), Japan
- Irish Health Products Regulatory Authority
- Saudi Arabia Food and Drugs Authority
- Swiss Medic
Service Fees
| Fee Type | Imported Products | Locally Manufactured |
| Class A Registration | USD 100 | USD 50 |
| Class B Registration | USD 200 | USD 50 |
| Class C & D Registration | USD 1000 | USD 100 |
| Annual Retention (Class A & B) | USD 50 | USD 50 |
| Annual Retention (Class C & D) | USD 300 | USD 50 |
| Variation Fee | USD 200 | USD 50 |
Manufacturer’s Quality Management System (QMS) Audit
PPB requires evidence of compliance with ISO 13485 or equivalent standards. On-site inspections may be conducted for high-risk devices or in cases of safety concerns.
Laboratory Tests
PPB may require laboratory testing of medical devices, particularly for diagnostics, to verify their safety and performance before market approval.
Renewal of Medical Device Registration
- Registration is valid for five years. It should be renewed every five years.
- Annual retention fees must be paid to maintain market authorization.
- Failure to retain a registration may result in suspension or cancellation.
Post-Registration Changes
Any modification to a registered device requires notification to PPB. Change categories include:
- Technical Changes: Affect safety, quality, or efficacy (e.g., modifications to design or materials).
- Review Changes: Require PPB approval (e.g., changes in indications for use, new models, labeling revisions).
- Administrative Changes: Updates to the manufacturer’s details or regulatory documents.
- Notification Changes: Can be implemented immediately after PPB acknowledgment.
Post-Marketing Surveillance (PMS) Activities
- Market surveillance: Continuous monitoring of medical devices in use.
- Adverse event reporting: Mandatory for manufacturers and distributors.
- Field Safety Corrective Actions (FSCA): Required for defective or non-compliant products.
Post-market clinical follow-up (PMCF): Ensures long-term safety and performance.
For more details, visit the official website of the Pharmacy and Poisons Board (PPB): Pharmacy and Poisons Board – Kenya .
If you need regulatory consultancy supports to register your medical devices or in vitro diagnostic medical devices with Kenya’s Pharmacy and Poisons Board (PPB) and market your devices in the country, please do not hesitate to contact us .
