The NMPA granted Innovation Approval to four medical devices in the first week of November 2021:
- Zhongyi Kangwei: Preimplantation Chromosome Aneuploidy Detection Kit
- Zhuo Ruan Medtech: Biological Hernia Repair Patch
- Weitai Medical Devices: Continuous Glucose Monitoring System
- Shenzhen Silicon Sensing Technology: Continuous Glucose Monitoring System
NMPA issued the list of 130 innovation approvals since the pathway established in 2014. For an English copy of the list, please email us at info@ChinaMedDevice.com
To download the NMPA Innovation Approval Procedure please click HERE
Why They Are Approved
NMPA gives explanations for each approval:
Preimplantation Chromosome Aneuploidy Detection Kit
This product is an in vitro diagnostic reagent developed based on a new generation of high-throughput sequencing platform, which can qualitatively detect the abnormal number of chromosomes in embryonic blastocyst biopsy cells, and is used to qualitatively detect the blastocyst trophoblasts of embryos cultured in vitro during IVF procedures The deoxyribonucleic acid (DNA) of the cell, through the detection of the DNA of some cells of the embryo, analyzes whether there is an abnormal number of aneuploidy in the chromosomes of the embryo, and assists the clinician to determine whether the embryo is implanted.
The sequencing principle of this product is different from similar products that have been approved for marketing, and the algorithm for embryo chromosome aneuploidy is different. Preimplantation chromosome aneuploidy detection can help reduce embryos with abnormal number of implanted chromosomes, and reduce repeated implantation failures, repeated miscarriages, and birth defects caused by implantation of abnormal embryos.
Biological Hernia Repair Patch
The product is a sandwich structure patch made of pig bladder basement membrane and pig small intestine submucosa after decellularization treatment and composite, with through holes. The product is sterilized by ethylene oxide and is for one-time use. Used for open and laparoscopic extraperitoneal repair of inguinal and femoral hernias.
The product is a bio-renewable material derived from natural tissues, which can be completely degraded after being implanted in the body. Its structure is designed as a bionic structure of “submucosa + basement membrane”, which has good tissue compatibility; the holes that penetrate the entire material accelerate the growth of surrounding tissue cells and facilitate the flow of tissue fluid. In addition, the composite structure of the product can improve the operating feel of the patch after hydration, which is conducive to shortening the operation time.
Continuous Glucose Monitoring System (by Weitai Medical Devices)
The product consists of a disposable glucose probe, a glucose signal transmitter, a glucose signal receiver, blood glucose management application software and supporting accessories. It can be used for continuous or regular monitoring of glucose levels in interstitial fluid of adult diabetic patients (≥18 years old). The product can provide and store real-time glucose values
The core technology of this product is the current/impedance dual-mode monitoring technology of anti-interference electrode design and impedance correction algorithm, polymer glucose permeable membrane material synthesis technology, single-process sensor electrode processing and glucose oxidase curing technology, which is a domestic initiative , Its clinical advantage is that it can achieve the maximum use period of 14 days without fingertip blood calibration.
Continuous Glucose Monitoring System (by Shenzhen Silicon Sensing Technology)
The product consists of a sensor package, a reader package or continuous glucose monitoring system software. It is used for continuous or regular monitoring of interstitial fluid glucose level in adult diabetic patients (≥18 years old). The product can provide and store continuous glucose values
The core technology of the product includes sensor electrode preparation technology based on the new glucose detection principle, and factory calibration sensor technology to achieve continuous glucose monitoring system without fingertip blood calibration. The product adopts the new redox reaction principle and the sensor adopts a new polymer design, which is a domestic initiative. Its clinical advantage is that no fingertip blood calibration is required within a 14-day period.
