The Chinese Food and Drug Administration is permitting the use of medical products for genetic testing of birth defects, which it banned in February (see IBO 4/15/2014). The government explained difficulties in regulating the quality of testing and the excessive fees charged by some test providers as reasons for the ban. Since 2011, products for prenatal screening have been used in China to detect diseases including cancer. According to some media, the government might have had concerns that the products would be used for sex determination of fetuses, which is illegal in mainland China. A report in the National Health and Family Planning Commission’s Health News indicated that the ban did not curb demand for fetal screening for diseases, with clandestine testing continuing. The change will allow resumption of tests detecting prenatal defects and diseases, with BGI’s sequencers approved, as were diagnostic kits approved for testing pregnant women considered high risk. Hospitals must receive clearance from the family-planning commission to purchase genetic-testing equipment.

Source: South China Morning Post