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Chapter

Title： Medical Device Quality Management System Regulations CH
Category： Ministry of Health and Welfare（衛生福利部）
Attachment：
Chapter 1 General Provisions § 1
Chapter 2 Quality Management System § 4
Chapter 3 Management Responsibility § 14
Chapter 4 Resource Management § 25
Chapter 5 Product Realization § 31
Chapter 6 Measurement, Analysis and Improvement § 60
Chapter 7 Essential Mode § 78