Customized medical device supervision policy helps clinical medicine

Clinical experts from Shanghai No. 9 People’s Hospital used three-dimensional integration to customize ear implants to make life-like ears and completed ear reconstruction and hearing reconstruction at one time for patients with ear defects.

The ear reconstruction and hearing reconstruction rehabilitation of a  9-year-old children was completed at one time without a second operation, which wasn‘t  reported in China or even Asia.In order to support hospitals to use three-dimensional integrated customized ear implants, in March this year, in accordance with the national provisions on the supervision and administration of customized medical devices, Shanghai Food and Drug Administration issued the filing certificate of “ear implants (customization)” to Shanghai No. 9 hospital (Shanghai Machinery Customization Record 2021-01).The filing no longer approves products, but emphasizes the ability of enterprises and hospitals, emphasizes that products with similar standards have been approved for listing, and emphasizes supervision after filing.Replacing the approval system with the filing system shortens the time to market for product and opens a green channel for clinical emergency use and innovative development.After using it, clinical experts report that the use of personalized ear implants can make the appearance of the reconstructed ear more accurate,  and can further improve the shortcomings of bloated and unrealistic shapes of the reconstructed ear; at the same time, it eliminates the need for trimming and shaping by  surgeon during the operation, shorten the operation time and reduce the risk of anesthesia;besides, the ability of customized ear implants to withstand external forces has also been greatly increased, and the risk of postoperative fracture is significantly reduced; for patients, the use of customized ear implants has faster recovery and better results, and compensates for the patient’s appearance， and brings hope to many families.

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