Register for Upcoming Webinar on DEC. 8 @ 11AM

2023 China NMPA Bluebook is here:

Two Domestic IVD Companies Obtained Innovation Approval


NMPA granted two Innovation Approvals in February.

  • Suzhou Beikang: Pre-implantation chromosome aneuploidy detection kit (semiconductor sequencing)
  • Xiamen Feishuo: Human EGFR / KRAS / BRAF / HER2 / ALK / ROS1 gene mutation detection kit (semiconductor sequencing)

In the Approval Notice for the aneuploidy kit, NMPA mentions the product “establishes a method for detecting pre-implantation chromosomal abnormalities by using embryo blastocyst stage cells, and adopts single-cell expansion technology to improve the alignment, uniformity and coverage of sequencing results; The analysis model of ploidy detection data reduces the analysis bias between samples caused by amplification and shortens the detection cycle to one day.”

For the EGFR / KRAS / BRAF / HER2 / ALK / ROS1 kit, NMPA says the product “is based on a common PCR platform that combines specifically modified primers and RingCap loop-mediated amplification technology to detect mutant genes contained in DNA / RNA samples. Using specific modified primers for PCR amplification of the target sequence, meanwhile, using RingCap loop-mediated amplification technology to modify the end of the amplified product, linking the specific sequence ends, combined with a special PCR reaction program and the use of RingCap enzyme, Library construction of target sequences in sample DNA / RNA for high-throughput sequencing is achieved on common PCR platforms to achieve accurate detection of multi-gene and multi-target mutations.”

For the review of 2019 Innovative Approval, Priority Review & Emergency Approval, please click HERE.

To keep up to date on NMPA (CFDA) changes, please opt in our monthly newsletter

About ChinaMed Device, LLC 

ChinaMed Device, LLC ( provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) legal representative 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.

Have Questions?

Related Services


Recent Events

Related Posts


Get Updated

Receive Updates in Your Inbox