NMPA approves key laboratory jointly established by Venus Medtech
Recently, the "Key Laboratory for Quality Research and Quality Control of Biomaterials for Tissue Regeneration" participated by Venus Medtech (Hangzhou) Inc. (hereinafter referred to as "Venus Medtech", 2500.HK), the leader in transcatheter structural heart valvular therapies in China, was approved as a Second-Batch Key Laboratory by the National Medical Products Administration (NMPA).
The laboratory is led by Sichuan University and jointly filed by the Center for Medical Device Evaluation of NMPA and Venus Medtech. The laboratory focuses on the scientific basis for biosafety and efficacy evaluation of innovative biomaterials and implantable devices as well as new evaluation methodology. It also conducts research in the regulatory science for conventional materials and implantable devices. The laboratory aims to keep China’s research in medical device R&D, registration and regulation abreast of the global leading edge, so as to better protect and promote public health.
In 2019, the NMPA officially launched the "Drug Regulatory Science Action Plan" and issued a series of policies and documents on the regulation of medical devices and innovative products. In the same year, Sichuan University established the Institute of Regulatory Science for Medical Devices and the NMPA Research Base of Regulatory Science for Medical Devices. Venus Medtech participated in the establishment of the "Key Laboratory for Quality Research and Quality Control of Biomaterials for Tissue Regeneration".
Eric Zi, Founder and General Manager of Venus Medtech, said, "The approval of the laboratory testifies to our industry-leading quality control system. We will make continuous efforts and work closely with Sichuan University and the Center for Medical Device Evaluation of NMPA to advance regulatory science for innovative devices in China."
As a leading innovative medical device company in the field of structural heart disease in China, Venus Medtech has been committed to improving its quality control system to help regulators streamline their processes. The company monitors each implantable product in real-time with its creative clinical data tracking system and real-time logistics monitoring system. Access to the system is open to regulators to enable timely and effective supervision. More importantly, the company uses big data to track the safety and effectiveness of its products over an extended period, so as to ensure patient safety and continuously improve product quality.
On the basis of its big data intelligent system, Venus Medtech has extended its solutions portfolio to digital healthcare. A digital healthcare department was set up in 2019 for developing intelligent medical device technologies and digital patient management products, such as Sensing Valve, a novel product under development.