An overview of the regulatory requirements for medical devices in Tunisia
£40.00
Ensure smooth market access in Tunisia with a thorough understanding of its medical device regulatory requirements
English
Medical devices, along with medicines, are essential elements of any healthcare system. They have to be effective, safe and of a high quality. However, in Tunisia, the regulation of medical devices remains less developed than the regulation of medicinal products. In this article, Olfa Ben Smida, Oumayma Ouerghemmi and Abderrazek Hedhili clarify the current requirements applicable to medical devices in Tunisia, in particular the technical import control procedure, and the different public organisations involved in ensuring compliance with these requirements. The article also describes the national vigilance system and the supply of medical devices to public health organisations.
Specification: 8 pages plus covers, in English, supplied by email as a PDF.
This article has been published in the August 2023 issue of the Journal of Medical Device Regulation.
