医疗器械零售的相关规定及规范化管理的建议

Relevant Regulations on the Retail of Medical Devices and Suggestions on Standardized Management

医疗器械是直接或间接用于人体的特殊商品。目前在法规层面,对于哪些医疗器械可以零售,零售企业如何识别说明书中标注的安全使用特别说明,如何做好零售医疗器械经营,均缺乏明确的要求,导致在日常经营过程中医疗器械零售企业存在困惑。由于零售经营企业和使用者的知识、认知良莠不齐,部分产品的非预期使用可能存在风险。本研究通过分析医疗器械零售的市场现状、监管要求、医疗器械零售与药品零售的相关要求对比,指出医疗器械零售面临的问题,提出规范医疗器械零售的意见和建议。建议监管机构细化监管措施,进一步规范医疗器械零售产品范围、产品标识、经营方式及经营范围;注册人、备案人做好零售产品标识安全使用提示;经营企业合规经营,并配备具备医疗器械专业知识、能够提供售前、售中、售后服务的零售人员;同时,监管机构、注册人或备案人、零售企业、医疗机构共同加强消费者安全用械教育,从而保障消费者准确购买并安全使用医疗器械。

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 cur⁃rent 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 compli⁃ant 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.