What kind of medical devices are applicable to the “Guidance for premarket review for medical devices cybersecurity”? Can the cybersecurity description document be submitted within the software description document?

The “Guidance for premarket review for medical devices cybersecurity” is applicable to the registration and application of Class II and Class HI medical device products with network connection function for electronic data exchange or remote control and storage medium for electronic data exchange.

The cybersecurity description document is independent of the software description document and shall be submitted separately.

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What Kind Of Medical Devices Are Applicable To The “Guidance For Premarket Review For Medical Devices Cybersecurity”? Can The Cybersecurity Description Document Be Submitted Within The Software Description Document?