[Legal Update] Medical Device Quality Management Rules Amended
2025. 11. 28
The National Medical Products Administration has recently promulgated the Medical Device Manufacturing Quality Management Regulations. The previous regulations of 2014 have been abolished.
The new regulations explicitly stipulate that medical device manufacturers should establish a quality management system covering the entire process, including design and development, production, quality control, product distribution, sales, and after-sales services. The regulations further require companies to ensure the implementation of quality and safety responsibilities, to promote risk management and digital-intelligent transformation, and to strengthen organisational and employee capabilities, factory facilities, equipment management, as well as document and data management.
Moreover, the regulations set out standards relating to procurement, raw materials, the manufacturing process, quality control, product traceability, contract manufacturing and outsourced processing, sales, and after-sales services. They also provide detailed provisions regarding non-conforming products, deviations due to discrepancies, rework, recalls, complaint handling, internal audits, and management reviews.
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