China CMDE recently issued an interpretation of the guidelines for Registration Review of Medical Device Usability Engineering.
In this document, China CMDE interpreted the background of the guideline. It is also to follow the medical device regulators in US and CE. Class II/III registration shall follow the guideline, but IVD is excluded. The key points of the documents are as the following:
- Background
- Scope
- Terminologies
- General Principles of the Regulations
- Verification and Validation of User Interface
- Relationship with clinical trials
- Supporting Information regarding Imported Medical Devices
- Requirements for using of commercialized software user interface
- Requirement regarding the Combination Product
- Remarks
If you are interested in one part or all of the document, contact us now.