China Market Access Medical Devices
Chinese Registration.
The Chinese registration of medical device aligns more with FDA in US and less with MDR in EU. For the technical documentation from manufacturers and review by authority are clear regulations applicable.
We have local office in Shanghai so we can follow all activities directly from China.
Compilation of Chinese electronic technical documentation
The technical documentation to authority should be in Chinese and in electronic form. Below are the main chapters which aligns to Table of Contents at International Medical Device Regulators Forum (IMDRF).
| Chapter | Item |
| CH.1 Administrative information | Application form ISO 13485 certificate Declaration of conformity as in EU (home country approval) Declaration of conformity of standards and regulation. |
| CH.2 Product summary information | Device description New: Worldwide notifiable incidents New: Worldwide marketing history. |
| CH.3 Non-clinical information | Risk management file Product technical requirement Type testing report Software file Pre-clinical study as biocompatibility report Essential safety and effectiveness requirements Shelf life and packaging verification. |
| CH.4 Clinical research data | Clinical evaluation Clinical study if applicable. |
| CH.5 Instructions for use and labels | All marketing materials as IFU and labels. |
| CH.6 Quality management system | General production information quality manual, quality objective and quality policy resource procedure Product realization procedure Design and development procedure Procurement procedure Production and service control procedure Monitoring and measuring procedure Measurement, analysis and improvement procedure QM system (personal, organ chart, layout plan of production site). |
