ZYA has obtained the Class III Medical Device Business License.
Date:2026-03-12
Recently, after strict review and approval by the Suzhou Market Supervision Administration, our company officially obtained the Class III Medical Device Business License on March 12, 2026. This marks that the company has legally and compliantly acquired the qualification to operate Class III medical devices, achieving an important milestone in the layout of our core business.
Class III medical devices belong to the high-risk category of medical devices and are subject to the strictest national regulatory standards and the most standardized access review process. Obtaining this qualification requires enterprises to meet extremely high entry standards in terms of warehouse supporting facilities, quality management systems, professional personnel configuration, and comprehensive supply chain management. The successful approval of this qualification is a high recognition by regulatory authorities of our standardized operating system, professional service capability, and overall management strength. It fully demonstrates the company's mature and complete quality control system and stable and reliable operating level.
The successful acquisition of this Class III medical device operation qualification effectively expands the business scope of the company's medical device operations, further improving the overall strategic layout of the company's health industry, and laying a solid qualification foundation for deeply developing the medical device sector, expanding the market comprehensively, and meeting diverse customer cooperation needs. In the future, the company will take this qualification approval as a new starting point, strictly comply with national laws, regulations, and industry standards for the medical device industry, continuously optimize and upgrade the quality management system, adhere to the core development philosophy of compliant operation and quality first, continuously improve professional service capabilities, steadily expand business territory, and continuously contribute to the high-quality development of the industry and create greater value for partners.