On the morning of April 22, the Medical Device Public Testing and Inspection Platform of the Anhui Digital Health Industry Innovation Institute was officially inaugurated at the Yangtze River Delta G60 Science and Technology Innovation Corridor (Hefei) Medical Device Innovation and Development Conference in Feixi County. As Anhui’s first enterprise‑operated medical device testing platform accredited with both CMA (China Metrology Accreditation) and CNAS (China National Accreditation Service for Conformity Assessment), its launch will provide significant support for the province’s medical device innovation and development.

This unveiling coincides with the platform’s official attainment of dual accreditation: CMA (qualification for inspection and testing institutions) and CNAS (laboratory accreditation).

The platform operates as an independent corporate legal entity. Jointly funded by the Zhongke (Anhui) Institute of Innovation for Intelligent Health, Yuanheng Medical Technology (Hefei) Partnership, and Feixi Industrial Investment Holding Co., Ltd., it established Zhongke Zhengyuan (Anhui) Testing Technology Co., Ltd., which is responsible for daily operations and management. Based in Anhui and serving the Yangtze River Delta region and neighboring provinces, the platform provides specialized third‑party medical device testing and inspection services.

To date, the platform has established a testing capability system covering multiple categories of medical devices, including active devices, non‑active devices, and in‑vitro diagnostics. It has approved coverage for 337 national standards and over 4,000 test parameters, and can carry out medical device registration testing, commissioned testing, R&D validation, and compliance consulting. The platform is authorized to issue third‑party professional testing reports and holds recognized authoritative qualifications.

In the future, leveraging the Anhui Digital Health Industry Innovation Institute, the Zhongke (Anhui) G60 Institute of Innovation for Intelligent Health, and other science‑and‑technology platforms, the platform will use its CMA/CNAS accreditation as a starting point to continuously enhance testing technologies and service quality. It will coordinate resources across government, industry, academia, and research to build a one‑stop “testing + consulting + training + research commercialization” service system that covers the full lifecycle of medical devices, create an “R&D‑testing‑registration” industrial ecosystem, and support the high‑quality development of the province’s medical device industry.

Source: Hefei Daily