In February, Qualtech introduced its audience an overview of medical device regulations in China. Our expert, Wendy Ke, delivered a speech, where she started with a registration preparation topic, which included information on materials needed for submission, medical device classification, and clinical evaluation materials.

Wendy also touched upon a registration reviewing process. Firstly, she guided the audience through the submission route and its specific features. Then described an evaluation organization structure and advisory type. Finally, the post-market process was assessed, with UDI, ADR, product re-call, and overseas inspections covered in detail.

At the end of the webinar, all the participants were able to raise their questions and get in-depth answers from Qualtech’s regulatory team. 

If you are interested in the Chinese market or currently have specific regulatory questions concerning a potential market entry of your product into the Chinese market, please feel free to contact us at your earliest convenience: