Shanghai, China, 28 March 2023 - MicroPort NeuroTech Limited (MicroPort NeuroTech™) 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 MicroPort NeuroTech™’s compliance with both ISO13485:2016 standards and the regulatory requirements in the United States, Australia, Brazil, Canada and Japan, which lays the groundwork and provides the momentum for the company's global development by effectively reducing the audit cost of products to enter global markets.
Initiated by the International Medical Device Regulatory Forum (IMDRF), the MDSAP program 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 all five countries. The MDSAP Certificate obtained by MicroPort NeuroTech™ covers the five countries and certifies the design, development, production, service, and distribution of extracorporeal life support system products.
MicroPort NeuroTech™ always adheres to the quality policy of “striving for innovation, focusing on providing safe and reliable products for patients, helping them improve the quality of life” and strictly controls product quality management. The Company’s quality management system is developed on the ISO 13485:2016 standard as the fundamental framework and incorporates national or regional regulatory requirements of target markets. To date, the system is compliant with relevant regulations and standard requirements of regions including China, the European Union, the United States, Brazil, Japan, South Korea and Canada.
Obtaining the MDSAP quality system certificate will make MicroPort NeuroTech™ products more advantageous and accessible in international markets, helping the company accelerate its worldwide expansion strategy. In the future, MicroPort NeuroTech™ will continue its commitment to providing high-quality and innovative products to more countries and regions around the world to benefit more patients with cerebrovascular disease.
About MicroPort NeuroTech™
Founded in Shanghai in 2012, MicroPort NeuroTech Limited (“MicroPort NeuroTech™”, stock code: 02172.HK), a subsidiary of MicroPort Scientific Corporation (“MicroPort®”, stock code: 00853.HK), is a pioneer and largest Chinese company in the neuro-interventional medical device industry in China, dedicated to providing innovative solutions for physicians and patients. MicroPort NeuroTech™ has gradually entered the top 10 countries and regions for a number of neuro-interventional surgeries, including the United States, Europe, South Korea and Brazil. In the future, MicroPort NeuroTech™ will invest more resources in innovation and development to provide more high-quality and innovative cerebrovascular and neuro-interventions solutions for physicians and patients.
More information is available at www.medneurotech.com.