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China blacklists unqualified medical devices
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China's State Food and Drug Administration (SFDA) has warned 13 companies about manufacturing unapproved medical devices, which have been blacklisted in a new round of spot checks.

Eighty percent of the photonic cosmetic machines (similar to lasers) from five companies and about 43 percent of high frequency electric knives (which can be used in dental procedures) were found to be unqualified in a spot-check that covered 17 provinces including Liaoning, Zhejiang, Beijing, Shanghai and Guangdong.

The unqualified medical devices also include metal bone and joint implants, single-use transfusions machines, high-frequency operation machines and endoscopic devices. An average of 13 percent of the medical apparatus were unqualified.

The administration warned the companies to adjust their production methods and strengthen quality control. Otherwise, they could face fines or be shut down.

In September, China's drug watchdog launched a six-month campaign to inspect licenses for medical devices. Companies that supply false data during the registration process will be blacklisted and publicly exposed.

According to the SFDA, regulations on the import and export of medical apparatus and the recall system will be revised to put greater emphasis on corporate responsibility.

The regulations will introduce basic requirements for the safety and effectiveness of medical apparatus and use of a uniform naming system.

A court in Shanghai on July 25 began hearing a case in which a couple is suing Shanghai East Hospital for allegedly attaching an unregistered, imported device to their son's heart.

In April, Zhou Yiqing, 13, received a ventricular assist device, a mechanical pump that helps the heart pump blood through the body. He died a year later after further heart surgery at the same hospital.

(Xinhua News Agency November 22, 2007)


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