To strengthen the supervision and guidance over medical device registration, and further improve the quality of registration review, NMPA has organized to formulate the Technical Review Guidance for the Registration of Disposable Breast localization Wire, Technical Review Guidance for the Registration of Dural (Spinal) Patches, Technical Review Guidance for the Registration of Customized and Personalized Equivalent Models of Bone Implants, Technical Review Guidance for the Registration of Finite ElementAnalysis Data of Orthopedic Metal Implants,Guidance for Clinical Trials of Hernia Repair Meshes, and Guidance for Animal Study of Bioabsorbable Coronary Artery Drug-Eluting Stents, and they were issued on July 7, 2020.
