A new regulation governing the supervision and management of medical equipment has been unveiled to ensure safety and effectiveness and encourage innovation.
The rule, which will take effect on June 1, is an amendment of a regulation first enacted in 2000. An executive meeting of the State Council, led by Premier Li Keqiang, endorsed the latest version in February.
"Safe and effective medical equipment has a direct bearing on public health and social stability," said Jiao Hong, food and drug safety chief of the China Food and Drug Administration. "The new rule will enhance routine oversight of equipment in the market."
The old version of the regulation could "no longer adapt to new situations," she said, citing unsatisfactory classification of equipment, insufficient oversight and unspecified legal accountability, among other problems.
When the new rules take effect, regulation of medical equipment will be divided into three categories according to the health risks they might pose for customers.
"Those deemed high-risk are expected to be regulated more strictly," said Tong Min, head of the medical equipment supervision and management department of the administration.
To better facilitate the regulation, the top drug authority will set up a monitoring system to track adverse events caused by medical equipment, along with a reappraisal mechanism and a recall system for defective equipment.
Those who manufacture or operate unregistered high-risk medical equipment, or manufacture or operate it without official endorsements will be subject to confiscation of their profits, production apparatus and materials, according to the new rule.
Also, violators may face fines up to 20 times the value of the equipment, as well as criminal charges, it stipulates.
At the same time, "the regulation also aims to provide incentives for innovation in the domestic medical equipment industry", Jiao said.
Currently, 90 percent of the large medical equipment used in China is imported, according to the Ministry of Science and Technology.
A lack of incentives has been blamed as the main cause of the problem.
(China Daily 04/01/2014 page2)