Shanghai, China, 11 April 2022 — Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd. (Endovastec™) recently announced that it has received a Medical Device Single Audit Program (MDSAP) certificate from the Technischer Überwachungs-Verein (TÜV SÜD), an international notified body, certifying Endovastec™’s compliance with both ISO13485:2016 standards and the regulatory requirements in Brazil, and Japan, which lays the groundwork and provides the momentum for the company's global development.
Initiated by the International Medical Device Regulatory Forum (IMDRF), the MDSA program is anchored in ISO 13485 and incorporates the regulatory requirements of five participating countries (the United States, Canada, Brazil, Australia and Japan). It allows an MDSAP-recognized auditing organization to conduct a single audit of a medical device manufacturer that satisfies the regulatory requirements of the above countries. The MDSAP Certificate obtained by Endovastec™ covers two of the above five countries, namely Brazil and Japan, and certifies the development, production and sales of minimally invasive treatment products for aortic and peripheral vascular diseases. Endovastec™ officially began the MDSAP audit process (for Brazil and Japan) in 2021, and passed the first and second stages of on-site audits by TÜV SÜD in March and June 2021, which led to the issuance of the MDSAP quality system certificate by the Notified Body TÜV SÜD in March 2022.
As a leading company in the sector of aortic and peripheral vascular intervention in China, Endovastec™ is committed to the Quality Policy of "Life regarded, Quality first, Innovation oriented, Serves sincerely", and maintains a stringent product quality management system. The company's quality management system is developed on the ISO13485 standard as the fundamental framework and incorporated national or regional regulatory requirements of target markets. To date, the system is compliant with relevant regulations and standard requirements of China, the European Union, Brazil, Japan, Argentina, Korea and other countries.
Obtaining the MDSAP quality system certificate will make EndovastecTM products more advantageous and accessible in international markets, helping the company accelerate its worldwide expansion strategy. The company’s global operations span 18 countries and regions across Europe, South America, and Asia Pacific. Its flagship products, including the Minos® Abdominal Aortic Stent-Graft and Delivery System, the Hercules® Thoracic Stent Graft System, and the Castor® Branched Aortic Stent-Graft System, have all been available in many overseas markets worldwide. The Hyperflex® Balloon Catheter has been approved in Japan recently.
In the future, Endovastec™ will continue its commitment to providing high-quality and innovative products to more countries and regions around the world to benefit more patients with aortic and peripheral vascular disease.