The purchase and sale of human organs are now banned in China after a new regulation went into effect on Saturday.

Strict rules have also been imposed on human organ transplants in response to fierce overseas criticism of China’s transplant industry.

Hospitals will be banned from taking organs without written consent from the donors, who are entitled to withdraw their decision at the last minute, according to the regulation.

The regulation was drawn up and made public in March 2006.

Only Class Three A hospitals – China’s top ranking comprehensive hospitals – can apply for transplant licenses. And the hospitals are required to have doctors with clinical organ transplant qualifications.

Qualified doctors, however, are banned from operating in unlicensed clinics, it added.

Clinics and hospitals must submit operation documents to their transplant ethnics committee for approval. Doctors should tell the committee the source of the harvested organ and whether it is a suitable match for the recipient.

It is estimated that two million Chinese people need transplants each year, but only 20,000 operations are conducted because of a shortage of organs.

Foreign media have reported that organs for transplant in China have been taken from executed criminals, but the Ministry of Health has repeatedly denied the claim, saying such reports were "untrue" and "malicious slander" of China’s judiciary system.

"Most organs in China have been voluntarily donated by ordinary citizens on their death, and a small number are from executed criminals who voluntarily signed donation approvals," ministry spokesman Mao Qun’an said earlier.