5 Trillion-Yuan Equipment Renewal and China's National Quota System for Large Medical Equipment
In March, the State Council launched the "Action Plan for Promoting Large-scale Equipment Renewal and the Trade-in of Consumer Goods," aiming to boost equipment investment in sectors like healthcare by over 25% by 2027 compared to 2023. The plan encourages qualified medical institutions to update equipment such as medical imaging, radiation therapy, telemedicine, and surgical robots.
As of June, 29 regions have published their equipment renewal strategies, targeting high-value medical equipment. These updates will be funded through various means, including government subsidies, commercial loans, specialty funds, hospital self-raise, and concessions from medical device companies.
Grassroots county-level markets, where the frequency of equipment updates is relatively slow, are expected to benefit the most.
The National Quota System for Large Medical Equipment in China
The management of large medical equipment in China follows a system based on allocation planning and permit issuance.
The allocation plan is typically formulated every five years and implemented annually. It includes the planned quantity, annual implementation schedule, regional layout, and allocation standards.
1995
In 1995, the Ministry of Health issued the "Interim Measures for the Allocation and Application Management of Large Medical Equipment," which first defined the concept of large medical equipment. Large medical equipment refers to high-tech, large-scale, precise, and valuable instruments and equipment used in medical and health work.
The "Interim Measures" also decided to implement the "three certificates" management for large medical equipment, namely the "Large Medical Equipment Allocation Permit," the "Large Medical Equipment Application Quality Certificate," and the "Large Medical Equipment Operator Technical Certificate."
2004
In 2004, the former Ministry of Health issued the first "Measures for the Allocation and Use Management of Large Medical Equipment," initiating a pilot for the centralized planning and allocation management of large equipment. Expensive large medical equipment was classified into Category A and Category B.
After the formation of the National Health Commission in 2018, category A equipment is managed and allocated by the National Health Commission, which also issues allocation permits. Similarly, the provincial health administrative departments manage and allocate category B large medical equipment.
This "three-certificate system" and "category-based management" established the preliminary management system for large medical equipment in China.
2017
In 2017, China strengthened the administrative supervision of large medical equipment. The "Decision of the State Council on Amending the Regulations on the Supervision and Administration of Medical Devices" reclassified the approval process for large medical equipment allocation from a non-administrative to an administrative licensing matter.
Medical institutions applying for large medical equipment allocation must adhere to the allocation plans, align with their functional positioning and clinical service needs, possess the necessary technical conditions and supporting facilities, and employ qualified and capable professional technical personnel.
2018
On March 29, 2018, with the approval of the State Council, the National Health Commission issued the "Management Catalogue of Large Medical Equipment Allocation Permits (2018)."
In June of the same year, the National Health Commission introduced the "Interim Measures for the Allocation and Use Management of Large Medical Equipment." These measures established requirements for the comprehensive management of large medical equipment and highlighted the need for evidence-based, dynamic adjustments to the management catalog.
According to the interim measures, the National Health Commission should assess the safety, effectiveness, economic efficiency, and suitability of large medical equipment usage and propose timely adjustments to the management catalog.
2023
On March 3, 2023, the National Health Commission issued the new "Management Catalogue of Large Medical Equipment Allocation Permits (2023)." Compared to the 2018 version, the number of managed items was reduced from 10 to 6, with Category A items decreasing from 4 to 2 and Category B items from 6 to 4.
For instance, the positron emission tomography-magnetic resonance imaging system (PET/MR) was reclassified from Category A to Category B. The 64-slice and above X-ray computed tomography scanners and 1.5T and above magnetic resonance imaging systems were removed from the list of managed items.
Additionally, the price cap for individual (sets of) Category A large medical equipment was increased from 30 million to 50 million RMB, and for Category B from 10-30 million to 30-50 million RMB.
These adjustments have effectively lowered the threshold for medical institutions to allocate large medical equipment. Observations show that since the beginning of the year, several regions, including Beijing, Zhejiang, Hebei, Anhui, and Henan, have been advancing the review of Category B large medical equipment allocation.
References:
- 撬动万亿市场规模的“以旧换新”进度条到哪里了？利好落地了吗？, MedTrend医趋势 2024.06.13, http://www.phirda.com/artilce_35372.html?cId=1&module=trackingCodeGenerator
- 分享 | 为什么大型医疗设备需要配置许可证？, 广东省医疗器械行业协会 2022-11-08, https://mp.weixin.qq.com/s?__biz=MzAxMTE0NDM5MA==&mid=2649452747&idx=4&sn=1c39bdd6709d7930f6150b05064f8942&chksm=835a4d62b42dc4741856ddb7897aa468a4e6cfcf3d190e0bb8c52521c668052c496a50bf1025&scene=27
- 5万亿设备更新|医疗设备配置启动，多地卫健委发布通知, 仪器信息网, 2024/03/21, https://www.instrument.com.cn/news/20240321/710104.shtml
- 肖月 et al., 我国大型医用设备配置应用管理研究 (Research on Collocation and Application Management of Large Medical Equipment in China), 卫生经济研究, 2021
- 关于印发大型医用设备配置与使用管理办法（试行）的通知, 卫生健康委 2018-06-13, https://zwfw.nhc.gov.cn/kzx/zcfg/jldxyysbpzxksp_241/201806/t20180613_1468.html
- 大型医用设备配置许可管理目录（2023年）政策解读, Hainan Government, 2023-3-22, http://dongfang.hainan.gov.cn/jdhy/zcjd/sjjd/202304/t20230407_3394568.html
