CFDA grants fast-track nod to Engineering Co., Capital Bio devices in under 5 months

Two new medical devices received China FDA marketing approval authorizations in a submission to approval time of just under 5 months, the regulatory agency said, under a process started in March last year. The approvals were for the Engineering Co.'s acellular corneal medical device to restore stroma integrity and CapitalBio Group's nucleic acid amplification microfluidic chip analyzer. Acellular release (Chinese) | Nucleic Acid release (Chinese)