On November 17, 2025, after rigorous audits and professional evaluation, Ningbo Inhal Medical Devices Co., Ltd. successfully obtained the Medical Device Quality Management System Certification. This milestone not only signifies that the company’s R&D capabilities in inhalation devices and supporting equipment have received authoritative recognition, but also means its products now meet the high standards required by the medical device industry. This enables the company to provide more innovative and reliable dry powder inhalation solutions for the global pharmaceutical industry.

The Medical Device Quality Management System Certification (ISO 13485) is an internationally recognized standard for medical device quality management. Its core principle ensures that the entire lifecycle—from design and production to distribution—complies with regulatory requirements, thereby guaranteeing patient safety and clinical efficacy. For enterprises in this sector, obtaining this certification signifies:

01 Full Lifecycle Compliance Upgrade

ISO 13485 requires companies to establish an effective quality management system, which helps improve product quality and safety while reducing the risk of defects and incidents.

02 Enhanced Market Competitiveness

In the medical device industry, quality is the cornerstone of corporate survival and development. Obtaining this certification means the company’s products have earned authoritative recognition for their quality and safety, significantly boosting market credibility and competitiveness. For domestic and international clients, this certificate serves as a crucial reference when selecting partners and products.

03 Driving Continuous Improvement and Innovation

The certification process is not merely an audit of the existing system but a catalyst for continuous improvement. Through certification, the company can identify weaknesses in their quality management and implement targeted optimizations. Simultaneously, it encourages the adoption of new technologies and methods to drive ongoing innovation in products and services.

04 Passport to Market Access

This certification serves as a "key" to entering high-end medical markets such as Europe, North America, Japan, and South Korea, laying the foundation for the company’s internationalization strategy.

Against the backdrop of intensifying global competition in the medical device market, establishing a standardized management system has become a critical measure for companies to ensure user safety and satisfaction, as well as to enhance product reliability and usability. This system is not only a "moat" for navigating market challenges but also a "strategic cornerstone" for achieving sustainable development.

Standing at this new starting point, Inhal Pharma will continue to deepen its expertise in the medical device field. Using the ISO 13485 certification as a foundation, the company will accelerate the R&D of high-end inhalation devices and supporting equipment. Through sustained innovation, strengthened end-to-end quality control, and global market expansion, it aims to provide more innovative and reliable products to the pharmaceutical industry, safeguarding human health.