修订关于加强医疗设备监管相关条例

The Chinese government has unveiled a revised regulation on the supervision of medical equipment in a bid to enhance its safety and effectiveness and safeguard public health.

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The revised regulation on the supervision of medical equipment has been endorsed by Chinese Premier Li Keqiang.

The Regulation on the Supervision and Administration of Medical Devices was first adopted at the 24th executive meeting of the State Council on December 28, 1999, and came into force as of April 1, 2000, covering any entity or individual engaged in the research and development, production, trading, use, or supervision and administration of medical devices. However, according to a statement from the State Council, 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 revised regulation, which will come into force as of June 1, 2014, medical equipment in China will be divided into three categories based on the potential health risks they might pose for the public (e.g., high-risk equipment will be placed under stricter control by the authorities). The revisions will come into effect on June 1, 2014.

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.

22 Responses to “修订关于加强医疗设备监管相关条例”

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