Nucleic Acid Amplification Detection Analyzer from Domestic Manufacturer Gains Approval

NMPA granted Innovative Device Approval to nucleic acid amplification detection analyzer, manufactured by Hangzhou Yousida, on December 30, 2019.

This product is based on the technology of three-stage magnetic permeation extraction and fluorescent polymerase chain reaction. It is used together with the matching detection kit for the qualitative detection of M. tuberculosis complex group nucleic acids derived from human samples.

There are two devices granted Innovative Approval Status in December, 2019.
• Mindray: Color Doppler ultrasound system
• Beijing Xinshiji: Coronary blood flow reserve calculation software

One device was granted Priority Review Status in December.
• Elekta: Magnetic resonance guided radiation therapy system

Review of Innovative Status in 2019

Of the 39 medical devices granted Innovative Device Status in 2019, only eight (just 20%) were imported devices. Since domestic and overseas manufacturers have equal opportunity for this program, U.S. and European companies may not be taking full advantage.

Contact us for the full list of imported Innovative Devices in 2019, the three fast-track channels and takeaways for overseas manufacturers.