Should there be a certificate of approval for the ear washing ball used in gynecology?

it should be

Gynecological ear washing ball should have relevant certificates, because gynecological ear washing ball is a medical device and needs to comply with relevant medical device regulations and standards. Specifically, gynecological ear washing balls need medical device registration certificate, production license and other related documents to ensure their safety and effectiveness. At the same time, when using gynecological ear washing balls, it is also necessary to abide by the relevant operating norms and precautions to ensure the safety and health of patients.