关键词: 医疗器械零售, 家用医疗器械, 经营质量管理

Abstract:

Medical devices are special commodities that directly or indirectly used on the human body. Currently， there is a lack of clear requirements for which medical devices can be retailed， how medical device retailers identify the special instructions for safe use marked in patient information leaflet， and how to do a good job in the operation of retail. In the daily operation process， medical device retailers are confused about that. Due to the uneven knowledge and cognition of retailers and users， there may be risks in the unintended use of some products. This study analyzes the problems faced by the retail of medical devices by analyzing the market， regulation and current situation of the retail of medical devices， comparing with the relevant requirements of the retail of drugs， and puts forward opinions and suggestions for further standardizing the retail of medical devices. It is suggested that the regulatory agencies refine the regulatory measures to further standardize the scope of retail products of medical devices， product identification， business models and business scopes. The registrants and filers do a good job in marking and providing safety use tips for retail products. The retailers achieve compliant operation and be equipped with retail personnel with professional knowledge of medical devices who can provide pre-sale， in-sale and after sale services. At the same time， the regulatory authorities， registrants or filers， retail enterprises and medical institutions jointly strengthen the education on safe use of medical devices for consumers， so as to ensure that consumers accurately purchase and safely use medical devices.

Key words: Retail of medical devices； , Household medical devices； , Operation quality management