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.
Writer:Andrew TAG:Medical DevicesIndependent Software AppendedNMPA