An overview of the regulatory requirements for medical devices and IVDs in Botswana
£40.00
Navigate Botswana’s evolving regulatory landscape: key insights into classification, registration pathways, and compliance for medical devices and IVDs
English
This article summarises the regulatory requirements that apply to medical devices, including in vitro diagnostic medical devices (IVDs), in Botswana. It provides details of the legislative framework and associated guidance documents, with links to the source documents. Definitions for a medical device and IVD are provided, along with an explanation of the classification system. Product registration is being phased in gradually and details are given on the three different registration pathways: registration through notification, registration through full evaluation and registration through abridged evaluation. Labelling and language requirements are also discussed.
Specification: 9 pages plus covers, in English, supplied by email as a PDF.
This article has been published in the May 2025 issue of the Journal of Medical Device Regulation.
