China: New regulation on Inspections

China’s National Medical Product Administration has legalized overseas inspections of device- and drug-makers, making risk-based audits routine tasks.

The scope of the inspections includes the R&D and manufacturing process of all devices and drugs that are currently marketed, or intended to be marketed, in China, to ensure that overseas sites supplying China adhere to Chinese quality and safety standards.

During the inspections, manufacturers should maintain normal real-time production processes, open relevant areas to inspectors, and provide relevant files, records and digital data as required.

The agency may then issue one of three decisions – pass, pass with corrective actions, or fail – and can issue penalties for products that fail, ranging from meetings and warning letters to suspension of importation, import bans and product recalls, or in the worst case a sales ban and revocation of the Product Import Certificate.

For more information please click here (in Chinese):

Click here for the NMPA Overseas Inspection regulation

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