In March 2021, the National Medical Products Administration (NMPA) appointed Jiangsu Medical Products Administration to carry out on-site inspection of Good Manufacturing Practice (GMP) quality management system of CH Biomedical. Inspection results showed that CH Biomedical is in compliance with GMP regulations without key nonconformities and successfully passed the inspection.
The Quality Management System (QMS) of CH Biomedical established on the combination of China NMPA regulation requirements, ISO 13485 standard, and USA FDA quality management system requirements for Class III medical device. The quality management system covers the full life cycle of the medical device, including design and development, production and product sales. It also includes the product surveillance, risk management of the whole life cycle of medical device, and strictly controls any product changes after the design freeze to ensure that the operation of the quality system incorporates all kinds of risk consideration.
CH Biomedical divided the quality system into nearly 30 quality system elements according to the international advanced quality management regulations and standards. Complete process and standards were set up for each quality system element, and the quality system is being continuously improved through the internal audit and management review.
As we successfully passed the GMP inspection by NMPA, we are committed to providing superior products and service worldwide in the future to help patients with advanced heart failure and their families in achieving better quality of life. We will make continuous improvement of our products with customers as the core and maintain an effective and high quality management system that achieves regulatory compliance.
On August 7, People’s Daily published an article titled Domestic Fully Magnetically Levitated VAD Serving Patients, commending CH Biomedical for breaking the international technological monopoly for developing a domestically produced, fully magnetically levitated VAD with independent intellectual property rights. The device is currently available in nearly 40 hospitals across China, enabling over 140 patients with advanced heart failure to embark on a “new life”.
Recently, at the 2022 China Medical Development Conference—widely regarded as the country’s premier medical forum—the Chinese Academy of Medical Sciences (CAMS) released two lists: China’s Major Medical Achievements of the 21st Century and China’s Important Medical Advancements in 2021. As a global innovator in the field of Ventricular Assist Devices (VADs), CH Biomedical’s independently developed CH-VAD (NMPA (A) 20213120987) was included in China’s Important Medical Advancements in 2021.
From 9th to 14th of June 2019, the Gordon Research Conference was held in Barcelona, Spain. The conference theme this year was on Mechanical Circulatory Support (MCS) and brought together world-renowned doctors, scholars, and researchers in MCS field. Dr. Chen, CEO of the company, and Dr. Lin, CTO were invited to attend the conference and delivered a plenary speech.
