This Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Basic Data
Standard ID
GB/T 42061-2022 (GB/T42061-2022)
Description (Translated English)
Medical devices - Quality management systems - Requirements for regulatory purposes
Sector / Industry
National Standard (Recommended)
Classification of Chinese Standard
C30
Classification of International Standard
03.100.70; 11.040.01
Word Count Estimation
40,440
Date of Issue
2022-10-12
Date of Implementation
2023-11-01
Issuing agency(ies)
State Administration for Market Regulation, China National Standardization Administration
