Registration Declared Documents Requirements for Product Registration Alteration and Renewal

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 Alteration of the Administrative License Item 

1. Software Research Documents

According to the network security updating condition, medical devices alteration of the administrative license items shall submit the research documents about if the changing part will affect the product safety and effectiveness:

  • Major network security update----Submit a single network security description document.
  • Only minor network security updates---Submit a single copy of a regular security patch description document.
  • No network security updates---Submit a statement of authenticity.

2. Product Technical Requirements

If applicable, product technical requirements shall reflect the changes about network security.

3. Instructions for Use (IFUs)

If applicable, Instructions for Use (IFUs) shall reflect the changes details about network security.

Registration Declared Documents Requirements for Registration Renewal

If applicable, medical device registration renewal product analysis report shall submit a regular security patch description document.  

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