Second-hand medical device market urgently requires 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 faced with 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 medical services. There are no comprehensive laws and regulations to constrain the medical devices that have been eliminated.

The refurbishment, transfer, and sales of these eliminated medical devices are not regulated by relevant laws and regulations. As a result, a large number of old medical equipments have been eliminated. Here some companies and individuals are busy refurbishing, transferring and selling the old ones. The chaos of medical device products.

Many of the refurbished medical devices have entered medical institutions. Some of them have been sent to the lower-level medical institutions free of charge, and some have also been recovered as part of maintenance. The draft of the relevant laws and regulations on second-hand medical devices was issued as early as in 2005. The name is “Regulations for the Administration of Refurbishment and Reuse of Medical Devices (Consultation Draft)”.

However, this management regulation has not yet been introduced, so it has not played an application management role. However, in 2005, the State Food and Drug Administration stated in a written statement on the handling of medical devices in Shanghai that whether the parts used for recycling old medical devices were either refurbished or assembled are production activities; enterprises must obtain a license for medical device operating companies. Business activities shall be carried out within the scope of the license; and medical devices produced must obtain a registration certificate, and no registration card can not be sold. This directive regulates the refurbishment of second-hand medical devices to a certain degree and ensures the quality of the medical devices. However, this directive can only play a role in the rehabilitation of medical equipment, but old medical equipment is still flowing into the market and medical institutions.

Therefore, formal regulations should be introduced to effectively standardize the secondary medical device market, standardize the behavior of the old medical device refurbishment, and ensure the safety of the people's machinery before they can bring the used medical device market into the scope of laws and regulations.