JSR Medical Co., Ltd. announced that they have received MDSAP (Medical Device Single Audit Program) approval on December 8, 2022.
MDSAP is a medical device safety and quality management system audit program established by International Medical Device Regulatory Forum (IMDRF). If MDSAP certificate is obtained, medical device regulatory approvals by the United States (FDA), Canada (Health Canada), Australia (TGA), Japan (MHLW) and Brazil (ANVISA) are fully or partially exempted, making it easier to export to those countries.
JSR Medical’s artificial intestinal management device that obtained MDSAP certification is a device that can replace the conventional stoma required by the majority of patients during the colorectal cancer surgery. It not only minimizes possible complications and recovery period, but also eliminates the need for stoma reversal surgery and ileostomy bag, which can dramatically improve the patient’s quality of life.
The product has already been approved for export by the Ministry of Food and Drug Safety of South Korea and its clinical trial in the U.S. is expected to start in April 2023. Along with the recent IDE submission to the FDA, JSR Medical is also preparing the CE MDR application for European market as well.
An official from JSR Medical said, “Through this MDSAP certification, we have proven that the safety and quality of our products meet the international standards, and we have been able to drastically reduce the cost and time required to enter the markets of the five countries. Also, we have established a bridgehead to advance into the Americas, Japan and Australia which account for more than 40% of the colorectal cancer surgery and its consumables market.”
Furthermore, JSR Medical official added that they would publicize the South Korean medical device technology that has grown to a world-class level and accelerate their entry into overseas markets.
