CFDA revised rule to strengthen the Chinese medicinal equipment safety
The Chinese government unveiled a revised regulation on the supervision of medical equipment in a bid to enhance its safety and effectiveness and safeguard public health. The revision, endorsed by Chinese Premier Li Keqiang, will come into effect on June 1st 2014. China first introduced the regulation on the supervision of medical equipment in 2000. According to a statement from the State Council, China's cabinet, the original regulation could no longer adapt to the new situations, citing unsatisfactory equipment classification, insufficient oversight, and unspecified legal accountability, among other problems. Under the new rule, medical equipment in China will be divided into three categories based on the potential health risks they might pose for the public. High-risk equipment will be placed under stricter control by the authorities, it said. Those who manufacture or operate unregistered high-risk medical equipment, or manufacture or operate it without official endorsement will have their illegal gains and production apparatus and materials confiscated, and could face fines up to 20 times as much as the value of the equipment, as well as criminal charges, the regulation said. Meanwhile, authorities will also set up a monitoring system for adverse events caused by medical equipment, a reappraisal mechanism for registered equipment in addition to a recall system for flawed equipment.(Information Source: Xinhua News)
