Venus Medtech Testing Center Receives National CNAS Laboratory Accreditation Certificate
The testing center of Venus Medtech (Hangzhou) Inc. (“Venus Medtech”) has recently been accredited by China National Accreditation Service for Conformity Assessment (CNAS), the first corporate testing center doing so, which features bioprosthetic heart valve and has the most comprehensive coverage of testing capacity. This marks that the system construction and testing capability of the testing center have reached the international first class, and its authority and credibility have been recognized globally. Venus Medtech will continue to improve the professional testing capability of the testing center, and enhance the product development and quality control capabilities, so as to lay a solid foundation for the globalization of innovative products.
CNAS is the only organization in China approved and qualified to issue national laboratory accreditation certificates by the Certification and Accreditation Administration of China. It enjoys high authority in the world with its accreditation certificate integrated into the MRA (Mutual Recognition Arrangement) system. Accredited institutes will be awarded with test reports within the scope of accreditation stamped with CNAS and ILAC-MRA marks.
As the leader in transcatheter structural heart valvular therapies in China, Venus Medtech has launched its first- and second- generation TAVR products in domestic market: VenusA-ValveTM and VenusA-PlusTM. With the CE certificate under MDR in EU, the company successfully launched VenusP-ValveTM, the first pulmonic valve developed and manufactured by a Chinese company, in Europe on April 8th, once again making history. Meanwhile, Venus Medtech also possesses innovative devices for mitral regurgitation, tricuspid regurgitation and other diseases, and is home to the most comprehensive pipeline for bioprosthetic valve products in China.
In view of the above, CNAS accreditation is crucial to the globalization of the company's products. It is learned that the scope of CNAS accreditation includes dozens of testing parameters such as valve pulsatile flow, valve durability, radial force, and structural component fatigue assessment, covering the physical, chemical and microbial properties of heart valves. Venus Medtech Testing Center is the first-party testing organization with the most comprehensive coverage of testing capabilities for " bioprosthetic heart valves".
As Chinese medical device industry is on a rapid rise, the insufficient testing resources for supporting medical devices, vulnerable testing capacity and long testing period fall short of the highly sophisticated requirements of advanced medical devices, which impede the healthy development of domestic medical device industry, and constitutes a sore point for national innovative medical device makers.
Eric Zi, Executive Director and General Manager of Venus Medtech said that "Venus Medtech has been committed to innovation and R&D for a long time, and is well aware of the importance of building a testing center. After this CNAS accreditation, the company will standardize management with higher requirements and continue to create more professional and qualify testing capability, so as to build world-class products and make China's intellectual manufacturing go globally."