GAUSH MEDITECH (02407) announced that its subsidiary, Gaosh Tailiang Medical Technology Co., Ltd. (Gaosh Tailiang), has officially received the ISO 13485:2016/EN ISO 13485:2016 medical device quality management system certification issued by DEKRA (Certificate No.: 6214501).

The certification comprehensively covers the complete process of design, development, production, and sales of intraocular lenses for treating cataract and presbyopia patients, as well as their supporting intraocular lens implantation systems.

DEKRA, established in 1925, is a globally leading independent non-listed professional inspection, testing, and certification organization covering extensive industry sectors. ISO 13485 is a medical device industry-specific quality management system standard issued by the International Organization for Standardization (ISO), focusing on "patient-centered" risk management and full-process quality control. It serves as a core compliance basis recognized by global medical device regulatory authorities, including China's NMPA, EU CE, and US FDA.

Obtaining this certification indicates that the company has established a quality management system covering the entire product lifecycle including design and development, production, inspection, and after-sales service, ensuring products meet regulatory requirements and continuous improvement.

The acquisition of this important qualification demonstrates the company's determination to enhance its quality management system and marks that the company has achieved international standard capabilities in medical device quality management, risk control, and compliance operations. This further establishes a solid foundation for the company's expansion into international markets.