Regulatory registration and testing service for active medical devices, passive medical devices, and in vitro diagnostic reagents. Supports compliance with medical device classification, clinical evaluation, and submission requirements for market authorization in regulated territories.
Manufactured by
Point Share Medicine Technology (Shanghai) Co., Ltd.
China
Point Share Medicine Technology is a comprehensive CRO+CDMO service provider for medical devices and IVD reagents in China, with offices in Beijing, Tianjin, Shanghai, Hangzhou, and Guangzhou. The company offers product design, prototyping, GMP pilot production, animal studies, clinical trials, and registration services. CDMO facilities include a 3,000 sqm GMP-compliant cleanroom with Class III medical device manufacturing license. The CRO team of 60 technical professionals specializes in aesthetic devices, injectable fillers, orthopedic devices, surgical navigation systems, ablation devices, and IVD reagents.
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