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Guidelines for Registration of Medical Devices Including In-Vitro Diagnostics

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Guidelines for Registration of Medical Devices Including In-Vitro Diagnostics

The Pharmacy and Poisons Board (PPB) is the National Regulatory Authority established under the Pharmacy and Poisons Act, Cap 244 of the Laws of Kenya, to regulate the profession of pharmacy and ensure the safety, quality and efficacy/effectiveness of health products and health technologies including medical devices and in vitro diagnostics.

Medical devices including In vitro diagnostics constitute a vital component of health products and health technologies that contribute to the attainment of the highest attainable standards of health for all citizens as envisioned in Article 43 of the Constitution of Kenya, 2010.

In 2007, the World Health Organization advised member states on the mechanism for the regulation of Medical Devices including In-Vitro Diagnostics (IVD’s) through Resolutions 67.29 and Resolutions 60.27 ‘regulatory system strengthening for medical products and the WHO global model regulatory framework for Medical Devices including In vitro diagnostics (IVDs).’ This recommendation was adopted by the PPB in 2012 resulting in evaluation of applications for marketing authorization of medical devices including IVDs.

This Guideline provides a framework for Evaluation and Registration of Medical Devices Including In-Vitro Diagnostics including the evaluation pathways to be followed for different applications. It provides for the risk classification of medical devices according to the different classes and specifies the requirements applicable for each class.

This document should be read alongside other PPB Guidelines and applicable legislation such as the Nuclear Regulatory Act (Cap 243) which provides for the production and use of radiation sources and management of radioactive waste. Applicants are therefore reminded that, notwithstanding the registration of a medical device under the Pharmacy and Poisons Act, the supply and use of any medical device including IVDs in Kenya should also comply with the requirements under other applicable legislations and the requirements to monitor market performance of the registered medical devices including IVDs.

This Guideline should be implemented while taking into consideration Good Regulatory Practices (GRP) that guide all personnel at the PPB in making regulatory decisions that are legal, clear, transparent, consistent, impartial, proportionate, prompt, and scientifically sound.

If there are any contradictions between the guidance documents and any written law, the latter shall take precedence.

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HPTPERHTPGUD011 Guideline for registration of MDs.pdfDownload

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