Discussion on Technical Review Points of Disposable Vascular Clip Products
With the increasing aging of the Chinese population,the incidence of vascular surgery diseases in clinical practice is increasing year by year.The industrial revolution of new materials,new methods and new technologies has promoted the vigorous development of vascular surgery,and many medical devices and products that are easy to operate,low risk,safe and effective in clinical applications have also been derived.Nowadays,vascular clamp products have been implemented for many years in China and widely used by clinicians.However,there is still a lack of relevant national and industrial standards and guiding principles of relevant products to effectively regulate the registration and application of products and product quality management,which easily leads to certain risks and challenges in clinical application and daily supervision and inspection by regulatory authorities.Taking the disposable blood vessel clamp product as an example,this paper,guided by the safety and effectiveness of the product,discusses the key and difficult issues such as the summary data,research data,clinical evaluation data,etc.in the registration application materials of the product,so as to facilitate the registration application of the product smoothly,and also provide a certain technical reference for the technical reviewers and supervisors of medical devices.
vascular cliptechnical reviewregistrationapplication datasterilizationdisposable use
万方数据
维普
