Hangzhou, China, September 5, 2024 --Two national standards, Medical Devices Utilizing Animal Tissues and Their Derivatives—Part 1: Application of Risk Management and Cardiovascular Implants—Cardiac Valve Prostheses—Part 1: General Requirements, developed with the contribution of Venus Medtech, have been approved by the Standardization Administration of China (SAC) for release. They are set to take effect on September 1 and July 1, 2025, respectively. Notably, this is the first time Medical Devices Utilizing Animal Tissues and Their Derivatives—Part 1: Application of Risk Management—previously an industry standard—has been issued as a national standard.

By offering comprehensive, science-backed institutional guidance, these standards will advance the development of medical devices using animal tissues and cardiovascular implants, driving ongoing industry upgrades and promoting high-quality development.

Standardization is key to driving innovation and industry progress. According to the National Medical Products Administration (NMPA), as of July 9, 2024, China has issued 1,978 standards for medical devices - 272 national standards and 1,706 industry standards. These standards can be further categorized into 269 mandatory standards and 1,709 recommended standards. Together, they cover almost all technical specializations of medical devices.

As a leading comprehensive platform company for innovative structural heart disease devices in China, Venus Medtech leverages standards development to translate our expertise and practical experience into innovation and real-world application. By actively participating in the development and revision of national and industry standards, we continue to foster progress in the structural heart field.

To date, Venus has led or participated in drafting nearly 10 standards, of which 2 national and industry standards and 4 social organization standards have been published, including General Requirements for Animal-Derived Pericardial Leaflets, Standard Test Methods for Durability Testing of Heart Valve Substitutes Implanted by Transcatheter Techniques, Transcatheter Implantable Pulmonary Valve Substitute, etc.

Looking ahead, Venus will remain dedicated to developing and improving standards for the industry while supporting their communication and implementation. This will foster technological innovation, driving continuous upgrades and high-quality growth across the industry. In our commitment to corporate social responsibility, we will actively strengthen relationships with stakeholders—including regulators, industry associations, and medical institutions—to promote the development of medical device standards and the standardization of industry practices, thereby contributing our expertise and resources to public health and safety in more effective ways.

About Venus Medtech

Venus Medtech (Hangzhou) Inc. (02500.HK) is committed to structural heart innovation. We are developing and commercializing comprehensive solutions for structural heart disease. Our robust pipeline, encompassing all four heart valves from TAVR, TPVR, TMVR, and TTVR to hypertensive renal denervation (RDN) therapy, underscores our unwavering commitment.

For more information, please visit https://www.mercenarygeneral.com

SOURCE: Venus Medtech (Hangzhou) Inc.

*Provided for informational and academic purposes only, this content is not intended as professional medical or legal advice. Venus Medtech makes no representations, warranties or guarantees regarding the completeness, accuracy, or timeliness of this content.

*Venus Medtech makes no representations, warranties or guarantees regarding the property or clinical performance of any medical devices mentioned.

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