ABSTRACT
Medical devices sector in Jordan: The directorate of controlled MDs and Cosmetics controls medical devices, including antiseptics and disinfectants (see Fig. 30.1). In the past, the JFDA used to depend only on catalogues, free sale certificate (FSC), and some internal instructions to custom release for medical devices. 30.2 Medical Device Market in JordanThe medical device market in Jordan comprises imported products and also products from local sources, including dental products, haemodialysis solutions, antiseptics, disinfectants, infusion set, plasters and surgical sutures. Local manufacturers should submit their site master file to the JFDA in order to be studied and to get an approval for manufacturing products. 30.3 Overview of Regulatory Environment
• Issued in accordance with Article No. (5) of the Drug & Pharmacy Law No. 88 • Law No. 80 for the year 2001 & its relevant amendment law No. 30 for the year 2003 • Article 1: These Directives are called Medical Devices Directives including antiseptics and disinfectants. Effective Date was its publication date in the official Gazette • Article 2: For the purpose of implementing these Directives, the terminology is set as mentioned in accordance with Article No. 2 of the law in addition to certain explanations for certain terminology such as
Article 1These directives are called Medical Devices Directives, including antiseptics and disinfectants. The date from which they have been effective is the date of its publication in the official gazette.
