ABSTRACT
This study briefly introduces the tongue diagnostic equipment of traditional Chinese medicine. It analyzes and discusses the key points of technical evaluation of tongue diagnostic equipment from the aspects of product name, performance parameters, image processing functions, product use methods, clinical evaluation, etc. It analyzes the safety risks and effectiveness indicators of tongue diagnostic equipment, hoping to bring some help to the gradual standardization of tongue diagnostic equipment and the registration of enterprises.
Subject(s)
Medicine, Chinese Traditional/methods , Tongue , Image Processing, Computer-Assisted , Diagnostic Equipment , Reference StandardsABSTRACT
Based on the current situation of approval and publicity of class II innovative medical devices in various provinces and cities, especially after analyzing the problems found in the review of class II innovative medical devices in Shanghai and the factors affecting the listing process of innovative medical devices, this study puts forward some thoughts on supervision for reference in establishing and perfecting systems and regulations, changing the review and approval thinking, extending services to the development of innovative medical devices and the formulation of clinical trial schemes.
Subject(s)
Device Approval , China , Equipment and SuppliesABSTRACT
By analysis on the risk management regulations and the situation of medical device after the product on the market, information list of problems and risk analysis process of the production and after-production were described, simultaneously, the suggestions were put forward to risk management after the product on the market, with the aim of providing reference for manufacturers and administrators.
Subject(s)
Equipment Safety , Product Surveillance, Postmarketing , Risk ManagementABSTRACT
Based on the investigation and analysis of the current situation for hearing aid fitting, some analysis results and suggestions for the development of the industry are presented, including manufacturer, association for medical devices industry and supervision division.