The National Healthcare Commission (NHC) has released two proposed updates to the Access Standards for Large Medical Equipment, which will impact Class A and Class B devices. These updates are currently open for public comments, allowing stakeholders to provide feedback on the proposed changes.
Details of the Proposed Updates
As per the documents, Class A large medical equipment encompasses heavy ion proton radiotherapy systems and high-end radiotherapy equipment. Class B includes positron emission magnetic resonance imaging systems (PET/MR), X-ray positron emission tomography scanners (PET/CT), abdominal endoscopic surgery systems, and conventional radiation therapy equipment. The new version of the access standards has seen a reduction in requirements related to functional positioning, technical conditions, supporting facilities and equipment compared to the 2018 version, while the demand for clinical services remains largely unchanged.
Recent Policy Developments
Last month, the NHC published the “Catalogue for the Management of Large Medical Equipment Configuration Licenses (2023).” This update has reduced the number of management items from 10 to 6, with Class A items decreasing from 4 to 2 and Class B items from 6 to 4. This adjustment is in line with the government’s initiative to “streamline administration, delegate power, and improve services.” For equipment with mature technology, stable performance, and standardized application, there is a proactive push to change its classification from Class A to Class B or to remove it from the Class B category altogether.-Fineline Info & Tech
