China Introduces Routine Overseas Device Inspections

January 16, 2019

China’s National Medical Products Administration — formerly part of China’s Food and Drug Administration — is increasing its scrutiny of foreign manufacturers and will begin routine risk-based inspections of foreign companies to confirm they are in compliance with Chinese regulations.

The new authority released new regulations device Inspection on Dec. 26, 2018, setting out how it plans to verify whether foreign device manufacturers’ research and development and manufacturing activities comply with China’s standards.

The NMPA has shifted its regulatory focus from “stringent pre-approval supervision to rigorous post-approval enforcement,” according to the law firm Ropes & Gray.

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