English
On July 22, the Guangdong Provincial Health Commission issued the Notice on the Guangdong Province 2018-2020 Class B Large Medical Equipment Configuration Plan and Technical Assessment Criteria (Trial) (hereinafter referred to as the Notice), indicating that by the end of 2020, the province plans to configure 1,615 units of Class B large medical equipment, including 813 new additions.
It is understood that China implements strict configuration permission management for large medical equipment. Class A large medical equipment is managed by the health administrative department of the State Council, while Class B large medical equipment is managed by provincial health administrative departments. Medical institutions shall not configure such equipment without approval.
In October 2018, the National Health Commission issued the Notice on Issuing the 2018-2020 Large Medical Equipment Configuration Plan, listing the national new additions of Class B large medical equipment. The Guangdong Notice has also clarified the number of new Class B equipment. Cyberlan Medical has integrated the two sets of data as follows:
In fact, the catalog of Class B large medical equipment has been expanded compared to the previous version.
On April 9, 2018, the National Health Commission issued the Large Medical Equipment Configuration Permission Management Catalog (2018). Compared with the 2005 catalog, medical equipment such as PET-CT, gamma knife, and surgical robots, which were originally in the Class A catalog, have been moved to the Class B catalog, and their configuration approval will be handled by provincial health commissions (health and family planning commissions).
The delegation of these configuration approval authorities will undoubtedly positively incentivize medical institutions to increase the configuration of large equipment, and more Class B medical devices will accelerate their entry into medical institutions.
The Notice requires that public medical institutions in Guangdong are strictly prohibited from applying for Class B large medical equipment configuration permits by means of cooperation, financial leasing, borrowing, or raising funds to purchase Class B large medical equipment without independent property rights.
At the same time, public medical institutions are encouraged to prioritize the configuration of domestic independent brand Class B large medical equipment, gradually improving the configuration level of domestic medical equipment.
In fact, in June 2018, the People's Government of Guangdong Province issued the Guangdong Province Action Plan for Deepening the Comprehensive Reform of Public Hospitals, stating that it is necessary to enhance the supply capacity of drugs and medical devices and increase the application of domestic medical devices and equipment.
Moreover, some provinces have clearly stated in tender documents that all medical equipment must be domestic.
For example, in June this year, according to the China Government Procurement Network, a tender document from Yunnan Province with a total budget of 270 million yuan showed that imported products were not accepted, and all equipment was required to be domestic.
According to the Notice, the annual implementation plan for Class B large medical equipment shall be implemented annually by the provincial health commission (cities under 委托 such as Guangzhou/Shenzhen) according to actual needs, and planning space shall be reserved for medical institutions funded by social capital.
At the same time, the procedures for social capital-funded medical institutions to handle configuration shall be simplified, guiding and supporting the development of social capital-funded medical institutions and new formats and models of medical and health services. Adhering to differential treatment, classified guidance, and reserving development space,
The Notice also emphasizes that the grade or bed size of social capital-funded medical institutions shall not be used as a necessary precondition for determining the configuration of Class B large medical equipment.