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.
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