The paper summarizes the authorized invention patents

device registration and the relevant published articles of acupuncture medical devices of TCM in recent 5 years

and analyzes the current status and challenges in this field. It is discovered that the optimization and substitution in diagnosis and treatment of acupuncture are involved in the development of acupuncture medical devices. The technology application of these devices are composed of traditional and emerging engineering technologies; and the theoretical guidance for their development requires the integration of traditional acupuncture principles with modern medical theories. The development of acupuncture medical devices highlights the characteristics of multidimensional integration

treatment for specific ailments

portability and wearability

painlessness and non-invasion

precision and personalization

as well as intelligent automation. Upon analysis

it is shown that in the development and product transformation of acupuncture medical devices in recent years

the theoretical principles of acupuncture of TCM have not been fully utilized yet

the transformation of patented product is low

the clinical evidence of product is insufficient

and the market competitiveness needs improvement. In the future

The theoretic guidance of acupuncture of TCM should be enhanced in the development of acupuncture medical devices

a production-education- research model with the combination of medicine and engineering be constructed

clinical verification of product be emphasized

and product development paradigms be advanced

so as to meet the demands of the medical market.