7 docs tagged with "qms"

Corrective and preventive action requirements under China GMP and NMPA inspection expectations.

Design control requirements under China's GMP framework — planning, input, output, review, verification, validation.

Good Manufacturing Practice requirements for domestic medical device manufacturers under NMPA Order No. 53.

Pre-approval and routine GMP inspections by NMPA, including overseas manufacturer inspections.

Overview of MDSAR 2021 GMP obligations and QMS requirements for medical device manufacturers in China.

Critical supplier controls and audit obligations under China's GMP framework.

China's YY/T 0287-2017 and its relationship to ISO 13485:2016 for medical device quality management.