New rule strengthens medical equipment safety
BEIJING - The Chinese government on Monday unveiled a new regulation on the supervision of medical equipment in a bid to enhance its safety and effectiveness and safeguard public health.
The regulation, endorsed by Chinese Premier Li Keqiang, will come into effect on June 1.
Under the new rule, medical equipment in China will be registered and 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.