An overview of the medical device regulations in the Kingdom of Saudi Arabia
£40.00
Stay compliant in the Saudi market: gain essential insights into classification, registration, and post-market requirements under the SFDA’s medical device regulations
English
Ilona Putz provides a comprehensive overview of the medical device regulations in the Kingdom of Saudi Arabia. Her article outlines the legal framework for medical devices and delves into the Saudi Food and Drug Administration’s classification system, which categorises medical devices based on their level of risk. The article also summarises the regulatory controls and requirements for manufacturers, Authorised Representatives, distributors, and importers. Detailed attention is given to the process of product registration, device approval timelines, and the associated fees. Additionally, the article discusses the mandatory post-market surveillance and vigilance processes, including reporting requirements for adverse events and the implementation of corrective actions.
Specification: 10 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.
