Four Guiding Principle Newly Released! About Network Security, Artificial Iintelligence.

On March 9th, CMDE issued four guidelines:

I.Guidelines for Medical Device Software Registration Review (Revised in 2022)

Applicable Scope：

This guiding principle is applicable to the registration application of medical device software, including class II and III independent software and medical devices containing software components (including in vitro diagnostic medical devices); It is applicable to the registration and declaration of self-developed software and ready-made software.

This guiding principle can also be used as a reference for the system verification of medical device software and quality management software.

II.Guiding Principles for Examination of Artificial Intelligence Medical Device Registration

Applicable Scope：

This guideline applies to the registration application of artificial intelligence medical devices, including the class II and class III artificial intelligence independent software and medical devices containing artificial intelligence software components (including in vitro diagnostic medical devices); it applies to the registration application of self-developed software , ready-made software components are executed by reference and are not suitable for external software environments.

This guiding principle can also be used as a reference for the system verification of artificial intelligence medical devices. If the quality management software adopts artificial intelligence technology to realize its function or purpose, it can also refer to the applicable requirements of this guiding principle.

III.Guidelines for medical device cybersecurity registration review (Revised in 2022)

Applicable Scope：

This guiding principle is applicable to the registration declaration of network security of medical devices, including class II and III independent software with one or more functions of electronic data exchange, remote access and control and user access, and medical devices containing software components (including in vitro diagnostic medical devices); it is applicable to the registration and declaration of self-developed software and ready-made software.

Among them, the network includes wireless and wired networks, electronic data exchange includes one-way and two-way data transmission based on network and storage media, remote access and control includes real-time and non real-time access and control based on network, and user access (such as medical personnel, patients, maintenance personnel, etc.) includes human-computer interaction based on software user interface and electronic interface.

This guiding principle can also be used as a reference for the system verification of medical device software and quality management software.

IV.Guidelines for registration review of ophthalmic laser photocoagulators

Applicable scope：

 This guideline applies to ophthalmic laser devices intended for the treatment of retinopathy by the use of lasers to generate thermal effects on biological tissue. According to the 2017 version of the catalogue of classification of medical devices, the product management category is category III, and the classification is coded as 16-05-02.

BradyKnows has seasoned staff in registration and can help manufacturers on legal compliance. If you have any questions, please feel free to contact us  info@bradyknowsmedical.com for more information.