Whether it belongs to, need to be defined according to its role, nature and other related to, medical device refers to the direct or indirect use of the human body instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials and other similar or related items, including the required computer software.
The utility is obtained primarily by physical and other means, not by pharmacological, immunological or metabolic means, or although these means are involved but only in an ancillary manner.
Article 5 of the Regulations for the Supervision and Administration of Medical Devices (2017 Amendments)
The research and development of medical devices shall be guided by the principles of safety, efficacy, and economy. The state encourages the research and innovation of medical devices, plays the role of the market mechanism, promotes the popularization and application of new medical device technologies, and promotes the development of the medical device industry.
Article 6
Medical device products shall comply with the mandatory national standards for medical devices; there is no mandatory national standards, shall comply with the mandatory industry standards for medical devices. Disposable medical device catalog by the state council food and drug administration in conjunction with the state council department in charge of health planning to develop, adjust and publish. Repeated use can ensure the safety and effectiveness of medical devices, not included in the directory of single-use medical devices. For the design, production process, sterilization technology and other improvements in repeated use can ensure the safety and effectiveness of medical devices, should be adjusted out of the single-use medical device directory.
Article 8 of the Law of the People's Republic of China*** and the State Against Unfair Competition (as amended in 2019)
Operators shall not make false or misleading commercial advertisements about the performance, functions, quality, sales status, user evaluations, or honors they have received of their goods, and deceive or mislead consumers. Operators shall not help other operators to make false or misleading commercial advertisements by organizing false transactions.
Article 3 of the Advertising Law of the People's Republic of China*** and the State of China (as amended in 2018)
Advertisements shall be truthful and lawful, and shall express the contents of the advertisements in a wholesome form of expression, in line with the construction of the socialist spiritual civilization and the promotion of the excellent traditional culture of the Chinese nation.
Article 4
Advertisements shall not contain false or misleading content, and shall not deceive or mislead consumers. The advertiser shall be responsible for the truthfulness of the content of the advertisement.