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NMPA Issues Guidance for On-Site Inspection of Independent Software Appended in Good Manufacturing Practice for Medical Devices

CCFDIE|Updated: 2020-06-04

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.