CFDA released the Cybersecurity Technical Review Guideline of Medical Device Registration in January,2017, it will be effective starting from January 1, 2018, are you ready to submit the applicable documents for Cybersecurity?
The Core point of this Guideline is medical device Data Security, focusing on medical device's technical assurance measures to maintain Confidentiality, Integrity and Availability. The Protective levels of Medical Device's Cybersecurity can be classified into Product Level and System Level.
The impacted products are Class II and Class III medical devices (both domestic and imported) with Electronic Data interchange, including Electronic Data Exchange, Remote Control or Storage Media.
According to the level of the impact on medical device, Cybersecurity Update can be categorized into Major Cybersecurity Update and Minor Cybersecurity Update. The documents submission for Cybersecurity are as follows:
(1) New Registration: a separate Cybersecurity Description File is required, and need to clarify the Data Interface and User Access Control in the Product Technical Requirement(PTR), the manual should add all the related Cybersecurity information.
(2) Change Registration: For a Major Cybersecurity Update, a separate Cybersecurity Description File is required; For a Minor Cybersecurity Update, a Description File for Regular Security Patch is required; If no Cybersecurity update, an Authenticity Statement is required.
(3) Extension Registration: A Description File for Regular Security Patch is required.
If you are interested in how to prepare the Cybersecurity Description File or related documents, please feel free to contact me at julianiu@ramed.top
Ramed Bioscience provides Regulatory Affairs Service and Business Development for Medical Device and In Vitro Diagnosis for China.