| 英文摘要 |
The main legislative purpose of the Medical Devices Act is to ensure the safety, efficiency and quality of use, and to ensure health. In addition to the important relationship between the safety and health of the public using medical equipment, the medical equipment management system has a strong risk level and classification management control, and involves the burden and efficiency of the administrative authority on medical equipment, as well as the manufacturing, import and export of medical equipment. The regulatory environment of the vending industry also indirectly affects the opportunities for the public to use new medical equipment. The current EU regulatory mechanism is of reference significance, enabling the industry to reduce market resistance and shorten the timetable in the medical device licensing system and in conjunction with my country’s medical device regulatory system. According to Article 82 of the Medical Devices Act, the use of medical equipment causes damage to the patient or user due to the use of the obligation of care. The obligation of care and beyond the reasonable clinical professional discretion shall be liable for damage to intentionally or violate the necessary medical instructions such as equipment introduction, warning slogans, messages or precautions, etc. |
