Documents Download

Announcement On Issuing The Guideline On The Preparation Of Annual Self-Inspection Report On Medical Device Quality Management System (No. 13, 2022)

GB/T 25102.1—2010 Electroacoustics—Hearing Aids—Part 1: Hearing Aids With Induction Pick-up Coil Input（April 1, 2011)

GB/T 25102.100 Electroacoustics—Hearing Aids—Part 0: Measurement Of Electroacoustical Characteristics（April 1, 2011)

YY 0989.7-2017 Implants For Surgery-Active Implantable Medical Devices-Part 7: Particular Requirements For Cochlear Implant Systems (Jan 1, 2018)

GB 6174.1-2015 Implants For Surgery-Active Implantable Medical Devices-Part 1: General Requirements For Safety, Marking And For Information To Be Provided By The Manufacturer (July 1, 2017)

Measures For The Supervision And Administration Of Medical Device Production (May 1, 2022)

Measures For The Supervision And Administration Of Medical Device Operations (May 1, 2022)

Good Clinical Practice For Medical Device (NMPA Decree 28, 2022) (May 1, 2022)

Guideline For The Registration Review Of Artificial Intelligent Medical Device (March 7, 2022)

Registration Review Guideline Of The Requirements For Submission Of Clinical Trial Data Of Medical Devices (November 25，2021)

Guidelines For Stability Studies Of Non-active Implantable Medical Devices (March 16, 2022 Revision)

Medical Device Software Registration Review Guideline（March 9, 2022)