Notice is given on the Renewal of Reregistration of Medical Devices Including In-Vitro Diagnostics

The Pharmacy and Poisons Board (PPB) of Kenya has issued a crucial notice regarding the renewal of re-registration for medical devices, including In-Vitro Diagnostics (IVDs). This directive mandates all Marketing Authorization Holders (MAHs) to initiate the renewal process for products nearing or exceeding their validity period, in accordance with Rule 9 of the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, 2022. The notice specifies staggered deadlines, with devices authorized in 2018 and 2019 requiring re-registration by January 1, 2026, and those authorized in 2020 needing renewal applications at least two months prior to expiration. This move underscores the PPB's commitment to ensuring the continued quality, safety, and performance of health products and technologies in the Kenyan market, necessitating prompt action from legal and regulatory professionals advising MAHs.

The regulatory landscape for medical devices and In-Vitro Diagnostics (IVDs) in Kenya has seen a significant development with the recent notice from the Pharmacy and Poisons Board (PPB) concerning the renewal of re-registration. This directive, aimed at ensuring the sustained quality, safety, and performance of these critical health products, places a renewed emphasis on compliance for all Marketing Authorization Holders (MAHs) operating within the Kenyan jurisdiction. The notice serves as a critical reminder of the ongoing obligations that extend beyond initial market authorization, highlighting the dynamic nature of regulatory oversight in the healthcare sector.

This development is particularly pertinent for legal practitioners and regulatory affairs professionals who advise manufacturers, importers, and distributors of medical devices and IVDs in Kenya. The PPB's communication outlines specific timelines and requirements, drawing attention to the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, 2022. Failure to adhere to these renewal mandates could result in significant market access disruptions and legal repercussions for non-compliant entities. This article will delve into the specifics of the PPB's notice, its legal underpinnings, and the practical implications for practitioners navigating Kenya's medical device regulatory framework.

The core thesis of this article is that proactive engagement with the PPB's re-registration requirements is indispensable for maintaining market authorization and ensuring uninterrupted supply of medical devices and IVDs in Kenya. Understanding the statutory basis, the procedural nuances, and the deadlines stipulated in the notice is crucial for mitigating risks and upholding regulatory compliance.

The regulation of medical devices and IVDs in Kenya falls primarily under the purview of the Pharmacy and Poisons Board (PPB), an institution established by Section 3A(c) of the Pharmacy and Poisons Act, Chapter 244 of the Laws of Kenya. This Act empowers the Board to grant or withdraw marketing authorization for medical devices and IVDs, subject to appropriate conditions, with the overarching goal of safeguarding public health by ensuring the safety, quality, and efficacy of health products and technologies.

Under this mandate, the PPB issues certificates of registration for medical devices and IVDs with a limited validity period of five years from the date of issue. This registration is further subject to the requirement of annual retention in the register and subsequent renewal. The regulatory framework also incorporates the Health Act 2017, which provides conditions for the establishment of a single regulatory body and its activities to control the marketing and use of health products and technologies. Kenya employs a risk-based classification system for medical devices, categorizing them into Classes A through D, with Class A representing the lowest risk and Class D the highest, influencing the depth of regulatory scrutiny.

Further guidance on the registration process is provided by the "Guidelines on Registration of Medical Devices including In-Vitro Diagnostics (HPT/PER/GUD/011)" and the "Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, 2022." These documents detail the requirements for initial registration, including the need for a local authorized representative (LAR) for foreign manufacturers, and outline the various evaluation pathways depending on the device's risk classification and prior approvals from stringent regulatory authorities. For imported medical devices, there is a dual regulatory framework that also involves the Kenya Bureau of Standards (KEBS) and compliance with the Pre-Export Verification of Conformity (PVoC) program, ensuring adherence to national and EAC standards.

The recent notice from the Pharmacy and Poisons Board specifically addresses the renewal of re-registration for medical devices and IVDs, emphasizing the obligation for Marketing Authorization Holders (MAHs) to act in accordance with Rule 9 of the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, 2022. This rule underpins the requirement for periodic renewal to ensure continuous compliance with safety, quality, and performance standards throughout a product's lifecycle in the Kenyan market. The notice sets out clear, albeit staggered, deadlines for different cohorts of registered devices.

For medical devices and IVDs that were initially granted marketing authorization in 2018 and 2019, MAHs are explicitly directed to ensure that their re-registration process is completed no later than January 1, 2026. This provides a critical window for affected entities to gather necessary documentation, submit applications, and address any deficiencies. For devices authorized in 2020, the requirement is to submit renewal applications at least two months prior to the expiration of their current marketing authorization. This staggered approach aims to manage the volume of renewals and allow MAHs sufficient time to comply, yet it also necessitates careful tracking of individual product expiry dates.

Non-compliance with these renewal requirements carries significant risks, including the potential suspension or cancellation of market authorization, leading to a loss of market access. The PPB's "Guidelines on Registration of Medical Devices including In-Vitro Diagnostics (HPT/PER/GUD/011)" provides comprehensive details on the documentation and procedural aspects of both initial registration and renewal. Key among these is the continued responsibility of the Local Authorized Representative (LAR) for foreign manufacturers, who serves as the primary liaison with the PPB and is responsible for ensuring regulatory compliance. The renewal process typically involves demonstrating that the device continues to meet the essential principles of safety and performance, often requiring updated technical documentation, quality management system certifications (such as ISO 13485), and evidence of post-market surveillance activities.

Furthermore, the regulatory landscape for imported medical devices in Kenya is characterized by a dual oversight mechanism involving both the PPB and the Kenya Bureau of Standards (KEBS). While the PPB handles the registration and marketing authorization, KEBS is responsible for ensuring conformity to national and East African Community (EAC) standards through its Pre-Export Verification of Conformity (PVoC) program. This means that even upon successful re-registration with the PPB, imported devices must continue to meet KEBS standards and obtain the necessary Certificates of Conformity for each consignment. This integrated approach underscores the comprehensive nature of Kenya's regulatory environment, designed to protect consumers from substandard or counterfeit products.

The Pharmacy and Poisons Board's notice on the renewal of re-registration for medical devices and In-Vitro Diagnostics is a critical regulatory update that demands immediate attention from all Marketing Authorization Holders and their legal advisors in Kenya. The specified deadlines, particularly the January 1, 2026, cut-off for devices authorized in 2018 and 2019, underscore the urgency of initiating and completing the renewal process. Proactive engagement with the PPB's guidelines and strict adherence to the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, 2022, are not merely procedural formalities but essential steps to ensure continued market access and uphold public health standards.

Practitioners advising MAHs must emphasize a thorough review of their product portfolios to identify devices requiring renewal, prepare comprehensive dossiers, and ensure that all necessary documentation, including updated technical files and quality management system certifications, are in order. The role of the Local Authorized Representative remains pivotal in navigating this process. Looking ahead, legal professionals should continue to monitor further pronouncements from the PPB and other relevant bodies like KEBS, as the regulatory environment for health products and technologies in Kenya is continually evolving to align with global best practices and address emerging public health needs. Staying abreast of these changes and fostering a culture of continuous compliance will be paramount for sustained success in the Kenyan medical device market.