SaMD Onsite Audit Technical Guideline for Medical Device Good Manufacturing Practice
On June 4, 2020, NMPA released the SaMD Onsite Audit Technical Guideline for Medical Device Good Manufacturing Practice in order to better supervise the implementation of GMP and its “Independent Software Appendix”. This guideline regulates the following details in the manufacturing process: organization chart and staff, factory and facilities, equipment, document administration, design and development, purchase, manufacturing management, quality control, sales and after-sales service, unqualified product control, and adverse event monitoring, analysis and improvement. NMPA will do inspections on such items during onsite audit. Bradynuoen can give trainings and help conduct mock-up audit to ensure fully compliance with China requirements.
