Hello, Everyone.
I am looking for a sample structure of what the registration for a medical device in China looks like, example for a class 2 or class 3 product.
I am aware that it should have:
General information covering applicant and manufacturer and agent information, etc
If you have an example to share that would be even better; redacted of course.
Thank you!
I am looking for a sample structure of what the registration for a medical device in China looks like, example for a class 2 or class 3 product.
I am aware that it should have:
General information covering applicant and manufacturer and agent information, etc
- Device description including name and model specification, intended use, working principles, and structure and composition
- Risk analysis and management including the risk report and management summary
- Technical documentation including the d&d files, performance testing report, the relevant standards (including the China standards), and if active the relevant electrical and EMC testing
- Clinical evaluation including clinical evidence and clinical trial exemption if applicable
- QMS including the certificates and any relevant facility inspection reports
- Labelling and IFU (DFU) for the packaging label and the IFU, all to be in Chinese
- Registration testing with the type testing completed by a NMPA designated test lab for the safety and performance testing
- Chemical and biological evaluation covering material safety report and biocompatibility
- PMS plan covering the plan for adverse event monitoring post and device tracking post approval
If you have an example to share that would be even better; redacted of course.
Thank you!
