Jun. 30, 2014
On June 30, 2014, the CFDA approved the registrations of BGI Diagnostics’ sequencers and its diagnostic kits for fetal chromosomal aneuploidy.
These are the first next generation sequencing diagnostic products approved by the CFDA.
The CFDA intends to continue processing the product registration of other innovative genetic sequencing diagnostic products, allowing faster and better public access to innovative medical instruments.
In April 2014, the CFDA banned all clinical genetic testing, except for projects approved by the government. This project is the first to be approved in the field since, indicating the CFDA’s intention to allow new products in the market, albeit under close scrutiny.