(SFDA) The State Food and Drug Administration of the People's Republic of China was founded in November 2003 and is directly under the State Council. The State Food and Drug Administration is in charge of comprehensive supervision on the safety management of food, health food and cosmetics and is the competent authority of drug regulation. For drug or medical device registration please see the SFDA's Regulatory Guide.
The agency is China's equivalent of the US Food and Drug Administration.

From Aurora Imaging Technology, Inc.;
The Aurora® 1.5T Dedicated Breast MRI System with Bilateral SpiralRODEO™ is the first and only FDA approved MRI device designed specifically for breast imaging. The Aurora System, which is already in clinical use at a growing number of leading breast care centers in the US, Europe, got in December 2006 also the approval from the State Food and Drug Administration of the People's Republic of China (SFDA).
'Some of the proprietary and distinguishing features of the Aurora System include: 1) an ellipsoid magnetic shim that provides coverage of both breasts, the chest wall and bilateral axillary lymph nodes; 2) a precision gradient coil with the high linearity required for high resolution spiral reconstruction;; 3) a patient-handling table that provides patient comfort and procedural utility; 4) a fully integrated Interventional System for MRI guided biopsy and localization; and 5) the user-friendly AuroraCADâ„¢ computer-aided image display system designed to improve the accuracy and efficiency of diagnostic interpretations.'

Short name: Mn-DPDP
This MRI contrast agent is a chelate complex of the paramagnetic metal ion manganese (Mn) and fodipir. Mn-DPDP (Teslascan) shortens the longitudinal relaxation time and is used for the T1 weighted enhancement of MR images. Mangafodipir trisodium accumulates after intravenous injection in the healthy tissue of the liver and improves the detection, localization, characterization, and evaluation of lesions of the liver, pancreas, but can also be used in cardiac MRI.
See also Hepatobiliary Chelates and Teslascan®.
The United States Food and Drug Administration (FDA) has granted marketing clearance 1997, to Nycomed Amersham's MRI contrast medium. Nycomed/Amersham, now GE Healthcare markets the product under the trade name Teslascan®.