Corporate Responsibilities

Quality Commitments

We have an independent quality and regulatory affair department and devote significant resources to quality management of our products. Our quality and regulatory affair department monitors every stage of our manufacturing processes and ensures consistent product quality that meets our quality management standards and policies. Our quality and regulatory affair department covers the following:

Quality Assurance

Our quality and regulatory affair department ensures our product realization process, including research and development, product designs, purchase of raw materials, manufacturing, product releases, product feedbacks and risk management, meet our quality management standards and policies.

Quality Control

Our quality and regulatory affair department inspects our products both during and after the manufacturing process, including raw material inspection, manufacturing process inspection and final products delivery inspection.

Test Center

Our quality and regulatory affair department conducts various tests of our products throughout the research and development and manufacturing processes, including metal and drug analyses and product fatigue tests.

Quality Management

Our quality and regulatory affair department establishes, maintains and improves our quality management system to ensure that our system is in compliance with applicable regulations and standards.

 

We have established a quality management system in accordance with the State Food and Drug Administration of the PRC (CFDA) regulations, and have obtained ISO 13485 certificates for the design, development, production and distribution of most of the products we currently offer. These certifications indicate our compliance with the recognized international standards for quality management and facilitate entry of our products into the European Union.

 

In addition, our quality and regulatory affair department is responsible for ensuring that we are in compliance with applicable regulations, standards and internal policies. Our senior management team is actively involved in setting quality management policies and managing internal and external quality performance.