We help emerging and established firms commercialize novel and innovative medical devices, including in vivo device, in vitro diagnostics and combination medical products in China. Since we began operations in 2001, clients have turned to us for strategic consulting and tactical solutions to understand and overcome Chinese regulatory, compliance, and clinical trial challenges at all stages of the medical product lifecycle. With Sinoaccess you have access to a team of consultants and project managers with a wealth of Chinese State Food and Drug Administration (“SFDA”), industry and healthcare experience to guide you through product local sales and marketing development and product launch, and to help you ensure post market product compliance.
By leveraging Sinoaccess’ comprehensive knowledge of SFDA and regulations, you can capture and grow market share, increase productivity, and stay competitive in an increasingly complex global marketplace. Whether you need to define your regulatory pathway, support your product with a well-designed clinical trial, prepare your team for SFDA audit, or ensure ongoing compliance, Sinoaccess has the experience and knowledge to lead you to success.