China – tightens regulations on risky medical technologies

(Stem Cells News image)

Chinese Medicine
Image by Victoria Reay via Flickr

BEIJING – China is tightening regulations on the clinical use of high-risk or ethically controversial diagnostic and therapeutic technologies.
The Ministry of Health (MOH) issued a government order on Monday requiring hospitals to get approval before doing things such as artificial heart implants and homogeneous organ transplants.

The regulation goes in to effect May 1. Hospitals already using the technologies are required to report to the Ministry for verification of qualifications within six months after that date.
The MOH said its aim is to prevent abuses of those medical technologies. Previously, only some needed government approval, it said, without giving further details.

Pei Xuetao, an expert on stem cells at the Academy of Military Medical Sciences, told Xinhua Wednesday that this is the government’s first complete system to oversee the clinical use of high-risk or ethically controversial medical technologies.
“However,” Pei said, “the difficulties for the MOH lie in the qualification verification process.”

The Ministry stated it would examine whether hospitals and medical institutes using those technologies have qualified medical experts, sufficient equipment and quality supervision measures. It would also compare standards with other countries.
The Ministry said it would appoint experts on medicine, law, ethics and management to examine the qualifications of these medical institutions.

Pei, also director of the Institute of Blood Transfusion at the academy, said hospitals should be further guided on what tests to conduct and what data to obtain for the verification process.

from China Daily

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