GMP&QMS

Regulations For The Administration Of Overseas Inspection Of Pharmaceutical & Medical Devices (December 26, 2018)

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)

Writing Specification For Periodic Risk Evaluation Report Of Medical Devices (NMPA No.46 2020)(Final)

NMPA Notice On Expansion Of The Pilot Medical Device MAH

Decree 64 Good Manufacturing Practice For Medical Devices

Decree 218 Annex 3 Good Manufacturing Practice Guidelines For Onsite Inspection Of Implantable Medical Devices

Decree 218 Annex 2 Good Manufacturing Practice Guidelines For Onsite Inspection Of Sterile Medical Devices

Decree 218 Annex 1 Good Manufacturing Practice Guidelines For Onsite Inspection

Decree 103 Good Manufacturing Practices On In Vitro Diagnostic Reagents

Decree 102 Good Manufacturing Practice For Implantable Medical Devices

Decree 101 Good Manufacturing Practices On Sterile Medical Devices