The CFDA issues technical review guidelines for the registration of medical device software

On August 5, 2015, the State Administration of Food and Drug Administration issued the Guidelines for the Technical Review of Medical Device Software Registration. Guidelines are used to guide manufacturers in submitting medical device software registration declarations, while regulating technical review requirements for medical device software.
guidelines apply to the registration and declaration of medical device software, including self-development, partial use of off-the-go software, and full adoption of off-the-go software. Medical device software includes stand-alone software and software components, independent software refers to the software as a medical device or its accessories, software components refers to as a medical device or its components, accessories composed of software.
the specificity of the software, the requirements for medical device software are further clarified under the current regulatory requirements, especially for software updates and software version upgrades. Guidelines include scope, basic principles, software description documentation, software updates, software versions, off-the-go software, registration and filing requirements, and list the individual software product technical requirements template as an appendix.
guidelines are guiding documents for manufacturers and reviewers, do not include administrative matters involved in review and approval, and are not enforced as regulations, and guidelines should be used in accordance with relevant regulations. (State Administration of Food and Drug Administration)