July 13, 2018

Large medical equipment is a special type of equipment with complex technology, large capital investment and high operational cost, creating a great impact on medical expenses. This April, China government has issued “The New Acceptance Catalogue for Large Medical Equipment”. Also in early June, “The Measurement of Large Medical Equipment (Trial)” (hereinafter referred to as the Measurement) has been published and was declared effective shortly after the publication date.

The Measurement includes 7 chapters and 49 clauses, covering the catalogue for large medical equipment, the configuration plan, the configuration management, and surveillance.

The description of each chapter are, hereby, outlined as follows:

1. Chapter I: The General Rule. This chapter clarifies the document purpose, reference, management mode, scope of application and management objective. It also includes the configuration plan and allocation license for large medical equipment, and ways to carry out the classification in accordance to the management catalogue.          

2. Chapter II: Catalogues. This chapter describes the large equipment as being divided into Class A and B, which are regulated by the National Health Commission and the Branch Health Commission in every province, respectively.

3.  Chapter III: The configuration plan. This chapter clarifies the principles, requirements and authority of configuration plan. Generally, the configuration planning of the large medical equipment is compiled once every 5 years. Furthermore, the configuration unit of large medical equipment in the first configuration shall not be more than 5, of which no more than 3 units are produced by the same manufacturer.          

4. Chapter IV. Configuration management. Clarifies the procedures of configuration licensing, and the management requirements for licensing audit.

5.  Chapter V. The Usage management. This chapter clarifies the requirements on the safe usage, and outlines the set of responsibilities which the medical institution shall undertake. In addition, the local health administration shall supervise and evaluate the usage situation, and shall establish the use of an evaluation system.          

6.  Chapter VI. The Supervision management. This chapter clarifies the contents and methods of supervision. In addition, it lists out all the responsibilities and corresponding penalties for illegal use.          

7.  Chapter VII. The Annex.


ReferenceOfficial press