An overview of the medical device regulations in the Islamic Republic of Iran
£35.00
Unlock the complexities of the Iranian medical device market and ensure regulatory compliance with this essential overview
English
This article by Ilona Putz summarises the responsibilities of the regulatory authority, the legal framework for device regulation in Iran, and the definition of a medical device. It then sets out the rules for classification and product registration/importation, as well as related documentation requirements. The article also discusses approval timelines and fees, post-market variations and renewals, packaging and labelling requirements, vigilance, and post-market surveillance requirements.
Specification: 8 pages plus covers, in English, supplied by email as a PDF.
This article has been published in the February 2024 issue of the Journal of Medical Device Regulation.
