Guideline & Standard

Guidelines For Medical Device Usability Engineering Registration Review (March 19, 2024)

Application Note On Guideline For TheReview Of Medical Device Usability Engineering Registrations (October 8, 2024)

Guidelines For Review Of Medical Device Usability Engineering Registrations (March 27, 2024)

Review Guideline Of Animal Studies For Medical DeviceRegistration: Part 1 Decision Principles(2021Revision)

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)

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

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

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