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Can the cybersecurity descriptiondocument be submitted within the software descriptiondocument?

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ku1314520 一阶会员 用户来自于: 广东省深圳市
2023-09-17 22:16

The“Guidance for premarket review for medical devicescybersecurity”is applicable to the registration and applicationof Class I and Class Il medical device products with networkconnection function for electronic data exchange or remote controland storage medium for electronic data exchange.

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

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发布时间
2023-09-17 22:16
更新时间
2023-09-17 22:16
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