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The Zhongguancun Shuimu Medical Technology Service Group was established in 2017 and is headquartered in the Beijing Yizhuang Economic and Technological Development Zone. It is committed to accelerating the process of registration and listing of innovative medical device products, and solving the "last mile" problem of industrialization for innovative medical device companies. The Group is the chairman unit of the Clinical Trial Branch of the China Association for Medical Devices Industry, the executive vice chairman unit of the Application Evaluation Branch of the China Medical Equipment Association, and the chairman unit of the Medical Device Committee of the Beijing Pharmaceutical Association.

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Shumuk University
Zhongguancun Shuimu Medical Technology Service Group

The group will continue to uphold the values of pursuing excellence, advocating quality, and acting with integrity and diligence. At the same time, we will seize the opportunity, aim at the international technological frontier, and further strengthen the construction of technical platforms and the standardization system for testing and inspection technologies
Enterprise services

As a pioneer and leader in third-party testing and certification services in China, Zhongguancun Shuimu Medical provides global clients with one-stop inspection, testing, calibration, certification, and technical services.
Inspection and testing service platform
Medical Device Design and Evaluation Platform
Clinical CRO Platform
Platform for Development and Production of IVD Standard and Quality Control Products
Medical Device CDMO Platform
digital operation platform for the life science industry
Enterprise services

As a pioneer and leader in third-party testing and certification services in China, Zhongguancun Shuimu Medical provides global clients with one-stop inspection, testing, calibration, certification, and technical services.
Water and wood incubator

Our service capability has fully covered the supply chain of various industries, including textile and apparel, footwear and bags, baby and children's toys and home living, electronics and appliances, medical and health, food and agricultural products.
Zhongguancun Shuimu Medical Device Professional Incubator
Exhibition Review
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Conference Express
Water and wood incubator

Our service capability has fully covered the supply chain of various industries, including textile and apparel, footwear and bags, baby and children's toys and home living, electronics and appliances, medical and health, food and agricultural products.
TEST QUALIFICATION
CMA qualification
CNAS qualification
Testing qualifications/certifications

We have established a clear governance structure in accordance with the listing requirements of the Shenzhen Stock Exchange's Growth Enterprise Board and other relevant national regulations and policies. This structure enables us to address internal and external challenges and achieve sustainable development.
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Beijing Zhongguancun Shuimu Medical Technology Co., Ltd
Building 1, No. 19 Yongchang South Road, Beijing Economic and Technological Development Zone
East China | South China | Northeast | Northwest18610900675/18610907598
North China | Central China | Southwest | Hong Kong, Macao, 17801120658/18610900670
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关于公开征求《软性内窥镜用高频手术器械注册审查指导原则（征求意见稿）》意见的通知

2023-12-07 14:14:00source |

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各有关单位：

　　根据国家药品监督管理局2023年度医疗器械注册审查指导原则制修订计划的有关要求，我中心组织编制了《软性内窥镜用高频手术器械注册审查指导原则》，经调研、讨论，现已形成征求意见稿（附件1），即日起在网上公开征求意见。

　　如有意见和建议，请填写意见反馈表（附件2），以电子邮件的形式于2023年12月30日前反馈至我中心。邮件主题及文件名称请以“《软性内窥镜用高频手术器械注册审查指导原则（征求意见稿）》意见反馈+反馈单位名称”格式命名。

　　联系人：常凤翥

　　联系方式：010-86452645

　　电子邮箱：changfz@cmde.org.cn


　　附件：1.软性内窥镜用高频手术器械注册审查指导原则（征求意见稿）（下载）

　　　　　2.意见反馈表（下载）


国家药品监督管理局

医疗器械技术审评中心

2023年12月5日

Company address：Building 1, No. 19 Yongchang South Road, Beijing Economic and Technological Development Zone

East China | South China | Northeast | Northwest：18610900675/18610907598

North China | Central China | Southwest | Hong Kong, Macao, ：17801120658/18610900670

ABOUT US
Company Introduction
Development History
Company Honors
Subsidiary
Team Introduction
Corporate News
Shumuk University
CORPROATE SERVICES
Inspection and testing service platform
Medical Device Design and Evaluation Platform
Clinical CRO Platform
Platform for Development and Production of IVD Standard and Quality Control Products
Medical Device CDMO Platform
digital operation platform for the life science industry
Shuimu Incubator
TEST QUALIFICATION
CMA qualification
CNAS qualification
CONTACT US
Recruitment information
Business inquiry
Industry Communication
Media Channels

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