Qianhai AnyCheck products obtained CFDA medical device registration certificate

2019-03-22 18:22

Good news! Recently, Qianhai AnyCheck officially passed the medical device quality management system (medical device GMP) assessment, in line with the medical device product access regulations, and in early 2019, successfully obtained the CFDA medical device registration certificate. This has a milestone significance for the development, production and marketing of Qianhai AnyCheck products:


1. Outstanding advantages in production and R&D:

At present, there are dozens of production companies similar to our products, but only two companies that have obtained medical device certification. This fully demonstrates the rigorous attitude and responsible spirit of Qianhai AnyCheck in the design, research and development, production and quality assurance of medical device products, and proves the strong technical strength and product superiority of Qianhai AnyCheck;

Qianhai AnyCheck has obtained the invention patent for the products recognized by CFDA, and has won the National Patent Excellence Award. It is recommended by the Ministry of Industry and Information Technology. It adopts the internationally popular system development model and advanced system processes and technologies. It has strong connectivity and compatibility. Sexuality and scalability, complete system solutions and data security protection, suitable for medical institutions, social welfare centers, old-age care institutions, health departments, suitable for hospitals of different scales and different grades, can meet different hospitals of different grades demand.

2. Higher brand recognition:

Obtained CFDA certification, which proves that our medical and health information and intelligent software and hardware products have significant clinical application value. We have obtained national research and development, production, sales, implementation and overall solutions in technology research and development, production quality assurance and policies and regulations. Recognition; it is easier to obtain customer trust and satisfaction in corporate bidding, marketing, and brand promotion;

3. IPO listing new journey:

Qianhai AnyCheck has obtained GMP production standard certification, and the product has obtained the CFDA registration certificate for medical equipment, laying a technical foundation for the biotech issuer to log on to the Hong Kong main board.

Medical device registration refers to the systematic evaluation of the safety and effectiveness of medical devices to be marketed and used in accordance with legal procedures to determine whether or not to approve their sales and use. Qianhai AnyCheck obtained the CFDA registration certificate for medical equipment, indicating that the products developed by our company have been fully recognized by the state in terms of safety and effectiveness!

Qianhai AnyCheck has established a strong R&D team according to the requirements of medical device GMP, providing strong technical support for the technical service of products; establishing a production site that meets GMP requirements, providing effective process quality assurance for products; establishing a complete The quality inspection agency provides comprehensive quality assurance for raw materials and products; establishes a comprehensive after-sales service department to provide customers with comprehensive after-sales service. This fully demonstrates that Qianhai AnyCheck fully integrates the needs of customers, cutting-edge technologies and medical system reforms to provide high-quality products for users' needs, provide high-quality guarantee for customers' health, and provide customers with full satisfaction. Directional service. At the same time, as the Group's more intelligent medical products are listed, it will also help to break the monopoly of imported products, reduce the cost of medical treatment, and make patients truly benefit.

In recent years, the Group's R&D and innovation have made tremendous progress, and the market has made continuous breakthroughs. The major wisdom medical projects have been reported frequently! Qianhai AnyCheck will strictly abide by the national medical device quality management norms, fully implement the concept of safe, effective, practical, convenient and advanced, improve the R&D management system, strengthen the quality management of medical device production, and strictly implement the medical device production quality management standards. Activities to ensure the safety and effectiveness of medical devices; and further improve the quality control level of self-developed medical products, in order to promote the development and quality control capabilities of Qianhai AnyCheck products to a new level, to achieve scientific and technological development, efficiency, front-end, Globalization! At the same time, improve the ability of after-sales service, provide customers with high-quality, high-level, all-round medical and health services, meet people's new expectations for health, and promote healthy China construction.