我国医疗器械售后服务现状及发展战略研究报告

Research Report on the Status Quo and Development Strategy of Medical Device After-Sales Service in China

目的:通过对行业监管法规政策、现状及主要矛盾、售后维保模式革新等问题进行深入调研与多维分析,为相关部门完善医疗器械监管法规政策提供思路与借鉴,为健全行业发展提供依据。方法:本文采用问卷调研的方式,共5025人参与调研,其中有效样本覆盖全国3665家医疗机构,其中三级医疗机构1503家,二级医疗机构1425家,其他医疗机构737家,二级以上医疗机构覆盖率为21.9%。结论:根据近年来我国医疗器械售后服务市场规模及行业格局演变的实际,分别对我国医疗器械售后服务市场的现行政策法规与执行标准、医疗器械的种类调研与分析指标、医疗器械的维修保养途径、行业现状与发展方向、医疗器械安全性与有效性水平的提高、完善行业监管等环节进行了深度解读论述。为完善我国医疗器械售后服务水平提出了一系列相关策略建议,对于我国医疗器械售后服务的健康发展具有一定指导意义。

Objective:To provide ideas and references for relevant departments to improve the regulations and policies of medical devices,and suggestions for the development of the industry through in-depth investigations and multi-dimensional analyses on the industry regulatory policies,current situation and main contradictions,after-sales maintenance mode innovation and other issues.Methods:A total of 5025 people participated in the survey in the form of questionnaires.The effective samples covered 3665 medical institutions in China,including 1503 tertiary hospitals,1425 secondary hospitals and 737 other medical institutions.The coverage rate of secondary hospitals and above was 21.9%.Conclusions:Based on the evolution of market scale and industry pattern of medical device after-sales service in China in recent years,the current policies,regulations and implementation standards on medical device after-sales service market,the types of research and analysis indexes of medical devices,the maintenance channels of medical devices,the status quo and development direction of the industry,the improvement on the safety and efficacy of medical devices,and the improvement of industry supervision in China were interpreted and discussed.In order to improve the after-sale service level of medical devices in China,a series of relevant strategic suggestions are proposed,promoting the healthy development of medical device after-sale service in China.