Draft Chinese SFDA Pacemaker Guidance

Attached is a .pdf of a draft guidance from the Chinese medical device regulatory agency (SFDA) that was sent out for comment. SoftwareCPR reviewed and provided a number of comments. It is one of a number of actions by the SFDA indicating movement to more active regulation of medical devices and the software they contain.

Draft SFDA Guidance of Pacemakers

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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