In order to further improve the quality of medical device registration and ensure the network security of related medical devices, the State Food and Drug Administration recently issued the Guidelines for the Technical Review of Medical Device Network Security Registration.
The guiding principle is that the General Administration of the People's Republic of China actively implements the relevant requirements of the Cyber ​​Security Law of the People's Republic of China and publishes the first registration technical review guidelines for medical device network security. This guiding principle applies to the use of network connectivity for electronic data exchange or Registration of remotely controlled medical device products. Focus on network security issues throughout the life cycle of medical device products, including the design, development, production, distribution, deployment and maintenance of medical device products. Applicants are required to consider the type, function, use, exchange method and requirements of relevant data, and consider the network security issues in combination with the product characteristics of medical devices, and adopt a risk management-based approach to ensure the network security of medical devices.
The publication of this guiding principle will help to improve the network security awareness of medical device registration applicants, relevant medical institutions and information service providers. Applicants should continue to pay attention to the network security issues of the medical device product life cycle process, and always ensure users. Privacy data and health data are secure.
Attached to the medical device network security registration technical review guidelines
This guiding principle is intended to guide registered applicants to submit medical device network security registration filing materials, and to standardize the technical review requirements for medical device network security.
This guiding principle is a general requirement for the safety of medical device networks. Applicants should submit the cybersecurity registration application materials according to the characteristics of medical device products, and judge whether the specific content in the guiding principles is applicable. Registered applicants may also use alternative methods of meeting regulatory requirements, but should provide detailed research and verification information.
This guidance is based on current regulations and standards systems and current cognitive levels, and is based on foreign regulations and guidelines, international standards and technical reports. With the continuous improvement of regulations and standards, as well as the continuous improvement of cognitive and technical capabilities, relevant content will be revised in due course.
This guiding principle is the guiding document for registered applicants and reviewers. It does not include the administrative matters involved in the review and approval, nor is it enforced as a regulation. The guidelines should be used in compliance with relevant regulations.
This Guiding Principle is supplemented by the Guidelines for the Technical Review of Medical Device Software Registration and should be used in conjunction with the relevant requirements of the Guidelines for the Technical Review of Medical Device Software Registration. This guiding principle is the general guiding principle for medical device network security. Other medical device product guiding principles related to network security can be adjusted, modified and improved based on this guiding principle.
First, the scope of application
This guideline applies to the registration of Type 2 and Type 3 medical device products with network connectivity for electronic data exchange or remote control. The network includes wireless and wired networks, and electronic data exchange includes one-way and two-way data transmission. Remote control includes real-time, non-real-time control.
At the same time, this guideline also applies to the registration of second- and third-category medical device products that use storage media for electronic data exchange, including but not limited to optical disks, mobile hard disks, and USB flash drives.
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