Notice on Launching Capability Assessment and Standard Development in the Medical Device Industry

  • 2022-06-27
In order to implement the requirements of national regulatory documents including the Development Plan for the Medical Equipment Sector during the 14th Five-Year Plan Period (GXBLG [2021] No. 208), the Guiding Standards for the Examination of Government’s Procurement of Imported Products (2021 Version), and the Notice on Implementing the Relevant Policies on Equal Treatment of Domestic and Foreign-funded Enterprises in Government Procurement Activities (CK [2021] No. 35), the China Industrial Control Systems Cyber Emergency Response Team and the China Association for Medical Devices Industry have decided to jointly launch capability assessment and standard development in the medical device industry.

Work objectives: to conduct scientific demonstrations of imported and domestic medical equipment (devices), build a set of rigorous, scientific, and complete technical means, identify the credibility of attributes of Chinese and foreign products and their important components and kits, spare parts, raw materials, and consumables to achieve statistical calculation of the localization rate of medical equipment (devices), and compare and analyze the performance and technical indicator systems of domestic and imported medical equipment (medical devices), so as to safely and orderly improve the localization rate, actively guide multinational enterprises to participate in the localization process, provide technical support for precision support of localization enterprises, and contribute to the achievement of the development goals of the medical equipment sector during the 14th Five-Year Plan period; to provide credible technical support and support for the approval and publication of relevant technical standards in connection with work including the formulation of supporting policies for the medical device industry, the tender and procurement by public medical institutions, the regulation over and traceability of product performance and technical standards, etc., the traceability of industry/enterprise high-quality development, and the financial services of the industry.
Project working group composition:
•Project group leader: Xu Shan
Secretary General of China Association for Medical Devices Industry
•Standing deputy group leader: Wang Yanzhen
Distinguished researcher at Beijing Information Science & Technology University
•Deputy group leader: Ma Dongyan
Director of Institute of Informatization Research of China Industrial Control Systems Cyber Emergency Response Team
•Deputy group leader: Wang Lin
China Association for Medical Devices Industry

According to the attributes and product categories of the medical device industry, the China Association for Medical Devices Industry (“CAMDI”) should organize the establishment of the corresponding standard preparation working committee and the corresponding standard working groups and expert teams, with specifical work as follows:

Organizing research, demonstration, and writing of the standard Calculation Method for Localization Rate of Medical Equipment;

Organizing research, demonstration, and writing of the standard Method for Comparing and Assessing Imported and Domestic Medical Equipment and Their Supporting Products;

Organizing research, demonstration, and writing of the standard Method for Assessing and Certifying Medical Equipment Industry/Enterprise Capabilities and Digital Transformation;

Organizing research, demonstration, and writing of the standard Method for Credibility and Traceability Identification of Medical Equipment and Supporting Products; and

Researching and demonstrating the core technologies and key topics concerning medical devices and their supporting products and industries, forming lists and regularly releasing them, guiding social resources to collaborate in tackling key problems, and providing references for relevant policy supporting and funding support.
The China Industrial Control Systems Cyber Emergency Response Team is responsible for the demonstration and construction supervision of the information systems and technical means necessary for realizing the above related standards and should organize related departments and experts to assist CAMDI in approving, demonstrating, reviewing, and publishing the above standards.

In order to successfully complete capability and digital transformation assessment in the medical device industry, it is hoped that all sectors of society and relevant enterprises and experts actively participate in the work to jointly advance the high-quality development of the capabilities and digital transformation in the medical device industry.

China Industrial Control Systems Cyber Emergency Response Team
China Association for Medical Devices Industry
June 10, 2022

Search