Criteria for determining major software updates
A software update that affects the intended use, use scenario or core function of a medical device is, in principle, a major software update, and its determination principles include but are not limited to:
- Refinement software update:
If it affects user decision-making (including decision-making ability, decision-making results, decision-making processes, user actions) or personnel (including patients, users, and other related personnel) safety, it is considered a major software update, such as changes in the input and output data type, system structure, user interface relationships, physical topology, core algorithms, core functions, diagnosis and treatment processes, or expected uses of the software, software systems, high-risk software items/software units undergo code refactoring, security level changes, and adjustments to alarm methods; However, simple improvements in computational efficiency, configurable diagnostic and treatment processes or working languages (i.e., users can retain the original diagnostic and treatment processes or working languages), textual modifications to user interfaces, and code refactoring of medium and low-risk software items/units are usually not considered significant software updates, unless it affects the safety or effectiveness of medical devices.
- Adaptive software updates:
If the software running environment crosses incompatible computing platforms (including hardware configuration, external software environment, essential software, network conditions), it is considered a major software update, such as the expected operating system software changing from Windows to iOS, replacing browser cores and essential software, changing network conditions from LAN to WAN, and changing computing platforms from general computing platforms to medical computing platforms, etc;
Due to the characteristics of the software, it does not have a physical entity, it is difficult to carry out a clear measure of the software update, this article introduces the principles of software update determination, the enterprise can be based on the principles of the article to identify the determination, to determine whether the software update affects the safety and efficacy of the medical device product, in order to effectively judge the software update of the quality management system to control the way, so as to determine whether to carry out the change of the registration of the medical device product to avoid the occurrence of illegal acts due to the lack of familiarity with the regulations and standards.
China is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China. BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com
Source：Xieshitong
Translated & edited： Bradyknow
