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China to restrict medical apparatus registration
China's drug watchdog has announced the launch of a six-month campaign to inspect the licenses of medical apparatus.
The campaign will start on September 18 and will focus on devices which are transplanted inside the human body, said Yan Jiangying, spokesperson with the State Food and Drug Administration (SFDA), on Tuesday.
The SFDA declared last month that it would verify the authenticity of applications for domestic and imported medical appliances, with a complete verification of cardiac pacemakers, valves, brackets and artificial joints by November.
Companies which report false information during the registration process will be blacklisted and shamed, said Yan.
According to the SFDA, regulations on the import and export of medical apparatus and the recall system are under revision, with a greater emphasis on corporate responsibility.
The regulations will introduce basic requirements for the safety and effectiveness of medical apparatus and uniform the naming system, Yan said.
A court in Shanghai on July 25 began hearing legal proceedings in which a couple are suing Shanghai East Hospital for allegedly attaching an unregistered imported device to their son's heart.
Zhou Yiqing, 13, received a ventricular assist device (VAD) in April 2004, but he died a year later after further heart surgery at the same hospital.
A VAD is a mechanical pump that helps the heart pump blood through the body.
According to Nanfang Daily, the parents had acquired a written certificate from SFDA, stating the German-made device had no registration from the drug watchdog.