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China mulls regulating installation, use of large medical equipment


The revised draft of a regulation would prohibit medical institutions in China from installing and using large medical equipment unless approved by authorities.

The revision to the regulation on monitoring medical devices, which has yet to be adopted, is intended to prevent medical institutions from abusing medical equipment to increase their earnings, according to the draft publicized by the State Council's Legislative Affairs Office.

Medical institutions should obtain approval from health authorities at the provincial level and above before installing large medical equipment, and their use of the devices will be evaluated and regulated by authorities, according to the draft.

Institutions that install large medical equipment should have matching technical conditions, the ability to use the devices, ancillary facilities and qualified technicians, the draft said.

Health authorities at the county level and above will issue a warning to institutions that install large equipment without approval, order them to stop using the equipment, confiscate their illegal gains, and impose fines.

In serious cases, offenders could be banned for five years from applying for approval, the draft said, adding improper use of the equipment could also result in fines, suspension of operations, or revocation of credentials.

The use of equipment in diagnosis and treatment is likely to account for a bigger share of medical institutions' earnings as policies to reduce patient expenses, such as one requiring medication to be sold at zero markup, have been introduced, according to a note explaining the need for the revision.

Medical institutions also intend to add more beds and large equipment to raise their returns, which needs to be controlled, the note said.

Opinions on the revised draft will be solicited until June 4.

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