Documents Download

Medical Device Clinical Trial Institution Conditions And Record Management Measures (March 9, 2022)

Notice Of NMPA On Expanding The Pilot Work Of The Medical Device Registrant System

Notice Of Shanghai Drug Administration, Jiangsu Provincial Drug Administration, Zhejiang Provincial Drug Administration, Anhui Provincial Drug Administration On Issuing The “Measures For Cross-regional Supervision Of The Medical Device Registrant Systemin The Yangtze River Delta Region (Trial)” (March 10, 2020)

Medical Device Cybersecurity Registration Review Guidelines (Revised, 2022)

Interpretation Of Relevant Regulatory Documents And Response Strategies On China National Medical Device Quality Sampling And Inspection Work In 2022

Quality Management System For Medical Devices Guidance On The Preparation Of Annual Self-Inspection Reports (Draft For Comments)

Guidelines For Technical Review Of Virus Inactivation Process Verification For Allograft Implanted Medical Devices (2011 Revision) (Ineffective)

Guidelines For Technical Review Of Virus Inactivation Process Verification For Allograft Implanted Medical Devices (2019 Draft For Comments)(Final)

Guidelines For Technical Review Of Registration Of Animal-Derived Medical Devices (2017)(Final)

Guidelines For Technical Review Of Registration Of Medical Devices For Human In Vitro Assisted Reproductive Technology(Final)

NMPA Interpretation On Review Guideline Of Animal Studies For Medical Device Registration (Final)

Notice On Doing A Good Job In Monitoring Adverse Drug Reaction Events Of Medical Institutions In The Hainan Boao Lecheng International Medical Tourism Pioneer Zone (Final)