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New rules to govern high-risk med tech

CHINA is tightening regulations on the clinical use of high-risk and ethically controversial diagnostic and therapeutic technologies.

The Ministry of Health issued a government order this week requiring hospitals to obtain approval before performing procedures such as artificial heart implants and organ transplants.

The regulation goes into effect on May 1. Hospitals already using the technologies are required to report to the ministry for verification of qualifications within six months of that date.

The ministry said its aim is to prevent abuses of medical technologies. Previously, only some technologies needed government approval, it said, without giving further details.

Pei Xuetao, an expert on stem cells at the Academy of Military Medical Sciences, said yesterday that the effort is the government's first complete system to oversee the clinical use of high-risk and ethically controversial medical technologies.

"However, the difficulties for the ministry lie in the qualification verification process," Pei said.

The ministry said it will examine whether hospitals and medical institutes using the technologies have qualified medical experts, sufficient equipment and quality supervision measures. It will also compare standards with other countries.

The ministry said it will appoint experts on medicine, law, ethics and management to examine the qualifications of these medical institutions.

Pei said hospitals should be further guided on the tests to conduct and data to obtain for the verification process.


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