Our Regulatory Affairs team, which deals with the approval of medical devices in the Chinese market, has in-depth knowledge. We focus in particular on a sound understanding of Chinese regulatory requirements and the relevant procedures. This includes knowledge of the relevant laws, regulations and guidelines in China.
In addition, it is important for us to have good communication skills in order to interact effectively with the Chinese authorities and regulatory bodies. This includes the ability to submit clear and concise documentation and applications and to respond appropriately to queries or requests from the authorities.
Furthermore, an understanding of the technical aspects of medical devices is important in order to correctly compile the necessary documentation and evidence for approval. This includes knowledge of product classification, clinical studies, quality control procedures and other relevant technical requirements.
Thanks to our global network, we have intercultural skills and can understand the cultural differences and business practices in China and respond appropriately.
Overall, the approval of medical devices in the Chinese market requires a broad range of skills, including knowledge of regulatory requirements, communication skills, project management, technical understanding and intercultural competencies.
We offer the above skills & benefits to all customers!