中国医疗器械关键核心技术和关键零配件现状调研报告(三期)

Research Report on the Status Quo of Key Core Technologies and Key Components of Medical Devices in China(Phase Ⅲ)

为保障我国医疗器械行业发展,特别是与公共卫生相关的关键核心技术及关键零配件,实现最大限度的自主可控,亟需通过数据调研,深入一线摸清现状,明确我国高端医疗器械科技攻关方向,保障我国公众用械安全。本文通过调研创新性地建立了医疗器械关键核心技术及关键零配件调研体系,并利用该体系对我国2021~2023年高端医疗器械关键核心技术及关键零配件情况进行了调研与分析。结果显示,血液净化类、数字减影血管造影(DSA)类、放疗类、乳腺机类、高频手术设备类(不含电刀)5条产品线的关键核心技术尚未全面实现国产化;血液净化类、核医学类、直接数字化X射线摄影系统(DR)类3条产品线的关键零配件尚未全面实现国产化。建议加强医疗器械关键核心技术及关键零配件的研发力度,提高自主创新能力;加大对相关产品的投入,以加快其商业化进程;同时,也需要加强对相关产品的监管,确保其质量和安全;加强与国际的交流与合作,引进先进的技术和管理经验,提升我国医疗器械产业的整体竞争力。

In order to ensure maximum autonomy and control over medical devices in China,particularly in key core technologies and key components related to public health safety,it is urgent to conduct thorough data research.This includes investigating the current situation at the frontline to clarify the scientific and technological research directions for high-end medical devices in China and ensuring the safety of public use.This article innovatively establishes a research system and tools for key core technologies and key components of medical devices.Using this system,we conducted an investigation and analysis of key core technologies and key components of high-end medical devices in China from 2021 to 2023.The results show that the key core technologies for the five product lines,including blood purification,DSA,radiotherapy,breast machines,and high-frequency surgical equipment(excluding electric knives),have not been fully localized.Besides,the key components for the blood purification,nuclear medicine,and DR product lines have not yet been fully localized.It is recommended to strengthen the research and development of key core technologies and key components for medical devices to enhance independent innovation capabilities.Further investment should be made in these products to accelerate their commercialization.At the same time,the supervision of these products should be reinforced to ensure their quality and safety.Strengthening international exchanges and cooperation,along with introducing advanced technology and management experience,will enhance the overall competitiveness of China's medical device industry.