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)