NMPA Issues Guidance for On-Site Inspection of Independent Software Appended in Good Manufacturing Practice for Medical Devices
To strengthen the supervision and inspection over medical device manufacturers' implementation of the Good Manufacturing Practice for Medical Devices and its appendix - independent software, and guide the regulatory authority to carry out on-site inspections and evaluation of inspection results, NMPA organized to formulate and released on June 4, 2020 the Guidance for On-Site Inspection of Independent Software Appended in Good Manufacturing Practice for Medical Devices.