CFDA Issues Guidance on Quality Control, Product Inspection

The China Food and Drug Administration (CFDA) has issued new guidance on quality control, finished product inspection, and other procedures for medical devices.

The document focuses on purchase control, process control, and finished product inspection — and includes a catch-all section on “other relevant requirements.”

The section on purchase control requires manufacturers to implement specific procurement control procedures. Raw materials and components that have a greater impact on the quality of finished goods must adhere to more rigorous standards. Inspection procedures for incoming goods must specify acceptance criteria, test methods, sampling procedures, and other information.

The process control and inspection section establishes similar rules for intermediate products and production processes. Manufacturers should consider how computer software affects product functionality when establishing quality control processes, the CDFA says.

The third section sets criteria for finished product inspection, including required processes, label inspections, and related tasks.

The final section on other relevant requirements addresses procedures for monitoring fluctuations in product quality and the ability to meet production demands.

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