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Supervision rules on medical equipment modified

Updated: May 19,2017 5:25 PM     english.gov.cn

The State Council has modified the supervision regulation on medical equipment, issuing a new version on May 19.

According to the modified regulation, if someone wants to conduct clinical testing on medical equipment, he or she should report to the local food and drug supervision bureau for the record. The testing institutions should also be put on the record by authorities.

If an institution wants large medical equipment, it should be qualified in terms of technology, supplemental facilities and staff, and apply for a permit from provincial-level health bureaus.

Food and drug supervision bureaus were asked to conduct more random checks on enterprises and institutions that produce, sell and use medical equipment.

Health bureaus were asked to supervise and evaluate the use of large medical equipment. If illegal use or overtreatment is discovered, the institutions involved will be punished.

Punishment and fines will be imposed as follows: Institutions that use large medical equipment without a legally obtained permit; institutions that conduct clinical testing against related regulations, and testing institutions that issue fake reports.

According to the document, “large medical equipment” refers to costly medical treatment equipment that is expensive to operate, sophisticated in technology, and would account for a large share of patients’ healthcare fees.

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