Jan 24th 2017 , China Food and Drug Administration (CFDA) released the ‘Registration Technical Guidelines for the Medical Device Network Security’ and it will come into force by Jan. 1st 2018. According to the guideline, data exchange, remote control and storage medium related class II or III medical devices are required to take measures to ensure the medical device network security.
Registration Declared Documents Requirements for Product Registration
1. Software research doucuments
The registration applicants should submit a ‘Network Security Describing Documents’.
2. Product Technical Requirement
The registration applicants shall clarify the data interface and user access control in the product technical requirements performance indexes:
- Data interface: Transport Protocol or storage format.
- User access control: User ID identification, user type and limitation.
3. Instructions for Use (IFUs)
IFUs shall provide the network security related explanation and clear the related requirements of operating environment( including hardware configuration, software environment and software condition), safety software( Ex: antivirus program, firewall and etc.), data and equipment interface, user access control mechanism, software environment with safety software updating.
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