NMPA Suspended The Import, Sales And Use Of ExFuse Bone Graft Of HansBiomed Corp. After Remote QMS Audit

National Medical Products Administration (NMPA) organized a remote QMS inspection of the ExFuse Bone Graft manufactured by HansBiomed Corp. (Certificate # 国械注进20193130564; Address: 64, Yuseong-daero 1628 beon-gil, Yuseong-gu, Daejeon, Korea).

The findings show that there existed issues in the process of production such as failure to take effective control measures for key raw materials and insufficient environmental monitoring in the clean area. Such findings are evaluated as non-compliance of China GMP and the appendixes.

In order to ensure the safety use of medical device to the public, NMPA decided to suspend the import, sales and use of ExFuse Bone Graft manufactured by HansBiomed Corp. since May 11, 2023.

China is not only enhancing the post-market surveillance of medical devices, but also conducting the pre-market audit of QMS for the product to be registered. NMPA will audit remotely or onsite to the facility. Once the findings are evaluated as non-compliance to China GMP, the sales in China will be suspended, or the registration of product will be terminated.

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