The rapid development of nanomaterials has brought groundbreaking opportunities for high-quality innovation in medical devices, but it has also become a new challenge for regulatory authorities. How to scientifically and rationally evaluate the risks of medical device products with nanomaterials and establish appropriate regulatory classifications have become critical research priorities. To solve this problem, this study focuses on medical devices with nanomaterials, conducts a comparative analysis of domestic and international regulatory classification policies, reviews the current registration status of related products, and provides recommendations on key considerations for the classification and regulation of medical devices with nanomaterials, which aims at promoting high-quality advancement in China's medical device regulation.
Nanostructures/classification* ; Equipment and Supplies/classification*

The placement of the flexible ureteroscopic sheath during lithotripsy may injure the ureter. We have developed a double-tube flexible ureteral access sheath. Thirteen patients with renal calculi were treated with double-tube and flexible sheath in one stage. CT examination of 13 cases showed that the ureter was normal. The double-tube flexible ureteral access sheath makes the operation of sheathing easy, safe and effective.

Objective To explore the interactive teaching model for CT imaging based on PACS, and provide the clinician and young radiologist with continued medical education. Methods 100 M trunk net was adopted in PACS and 10 M was exchanged on desktop. Teaching model was installed in browse and diagnosis workstation. Teaching contents were classified according to region and managed according to branch model. Text data derived from authoritative textbooks, monograph , and periodicals. Imaging data derived from cases proved by pathology and clinic. The data were obtained through digital camera and scanner or from PACS. After edited and transformed into standard digital image through DICOM server, they were saved in HD of PACS image server with file form. Results Teaching model for CT imaging provided kinds of cases of CT sign, clinic characteristics, pathology and distinguishing diagnosis. Normal section anatomy, typical image , and its notation could be browsed real time. Teaching model for CT imaging could provide reference to teaching, diagnosis and report. Conclusion PACS based teaching model for CT imaging could provide interactive teaching and scientific research tool and improve work quality and efficiency.