Medical Devices

REQUEST FOR COMMENTS ON MEDICAL DEVICES REGULATION

Medical Device Regulation in Kenya will be supervised and directed by Kenya Pharmacy and Poisons Board (PPB). Classification, requirements and evaluation of Medical Devices will be mainly simulation of rules and regulations recognized by the international regulatory benchmarks, which are mainly:

The Pharmacy and Poisons Act Chapter 244 of 2002
Global Harmonization Task Force (GHTF) for Medical Device EU Medical Device Directives 93/42/EEC,
EU In Vitro Diagnostic Device Directive (IVDD) 98/79/EC and EU Active Implantable Medical Device Directive (AIMDD) 90/385/EEC.
US FDA (United States Food & Drug Administration)
Australia TGA (Therapeutics Goods Act)
The regulation of medical devices in Kenya is aimed at maintaining balance between ensuring product safety, quality and effectiveness and providing the public with timely access to medical devices and preventing the entrance of unsafe or ineffective devices into the market.

Medical Devices Regulation Guidelines: DOC

Application Form for Registration of Medical Devices: DOC

The Board requests for you comments on the above documents. Please send your comments to drugreg@pharmacyboardkenya.org

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