An overview of the medical device regulations in Jordan
£50.00
A guide to Jordan’s medical device regulatory system, covering classification, registration, local representation, dossier requirements, timelines, and post-market expectations
English
Ilona Putz provides a comprehensive overview of the regulatory framework governing medical devices in Jordan. Jordan’s regulatory system is grounded in national laws and guidelines and aligns closely with the European Union’s Medical Device Regulation (EU) 2017/745 for device classification. This article details the responsibilities of manufacturers, importers, distributors and Authorised Representatives, emphasising the need for a locally licensed agent to manage registrations and market access. It outlines the device registration process, dossier requirements, approval timelines, fees and the distinctions between administrative variations and those requiring formal approval. Requirements for packaging, labelling, and renewals are also described. While vigilance reporting is encouraged, it remains voluntary, with channels available for submitting adverse incident reports. By consolidating regulatory obligations and procedural expectations, this article serves as a practical reference for stakeholders seeking to navigate Jordan’s medical device regulatory landscape.
Specification: 10 pages plus covers, in English, supplied by email as a PDF.
This article has been published in the February 2026 issue of the Journal of Medical Device Regulation.
