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The China National Medical Products Administration (NMPA) certification, formerly known as CFDA (China Food and Drug Administration) certification, is required for medical devices intending to be marketed and sold in China. It ensures that medical devices comply with Chinese regulatory standards for safety, efficacy, and quality. NMPA certification involves a rigorous process that includes testing, clinical evaluations (if applicable), and quality management system audits. Once certified, the device can be legally imported, manufactured, or sold in China.
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