Nucleic Acid Amplification Detection Analyzer from Domestic Manufacturer Gains Approval

NMPA News Roundup December 2019
January 14, 2020
NMPA Final Guideline on How to Address “Submission Deficiency” in China
January 23, 2020

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.

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

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About ChinaMed Device, LLC 

ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.