Release date: 2014-10-29 With the rapid development of China's medical and health undertakings, a large number of medical devices in China's medical institutions are facing upgrading, and a large number of medical devices will become second-hand medical devices, such as b-ultrasound, ct, x-ray machines, nuclear magnetic resonance and other large-scale medical treatments. Equipment, how to deal with these eliminated medical devices, has not been bound by a comprehensive legal regulation. There are no relevant regulations to regulate the refurbishment, transfer and sale of these eliminated medical devices, so that a large number of old medical equipment have been eliminated. Some enterprises and individuals are busy renovating, transferring and selling the old ones. The chaos of medical device products. Many of the refurbished medical devices have entered the medical institutions, and some have been given free of charge to lower-level medical institutions in the form of assistance, and some have been recycled as parts for maintenance. The draft of the consultation on the relevant laws and regulations on second-hand medical devices was introduced in 2005, and the name is “Regulations on the Supervision and Administration of Refurbished Medical Devices (Draft for Comment)â€. However, this management regulation has not been introduced, so it has not played a management role in the application. However, in 2005, the State Food and Drug Administration stated in the instructions on the treatment of medical devices in Shanghai that the recycling of used medical devices, whether it is renovation or assembly, is a production act; enterprises must obtain medical device business licenses. Under license In the scope of business activities; and the production of medical equipment to obtain a registration certificate, no registration certificate can not be sold. This indication regulates the behavior of second-hand medical equipment renovation to a certain extent, and guarantees the quality of medical equipment. However, this instruction can only block the refurbishment of medical equipment, but the old medical equipment is still flowing into the market and medical institutions. Therefore, formal regulations should be introduced to effectively regulate the second-hand medical device market and regulate the old medical device refurbishment behavior in order to protect the safety of the people in order to incorporate the second-hand medical device market into the scope of laws and regulations. Source: China Pharmaceutical Network YT-S350 YT-S350 Shenzhen Sunshine Technology Co.,Ltd , https://www.szyatwin.com
Second-hand medical device market needs legal regulation
With the rapid development of China's medical and health undertakings, a large number of medical devices in China's medical institutions are facing upgrading, and a large number of medical devices will become second-hand medical devices, such as b-ultrasound, ct, x-ray machines, nuclear magnetic resonance and other large-scale medical treatments. Instruments, how to deal with these eliminated medical devices