|As more and more medical devices
rely on software to function, regulatory
requirements for software become
With so many international regulatory bodies governing different countries and industries, it can be difficult for manufacturers to stay abreast of all of the changing regulatory environments and requirements across the globe. On August 5, 2015, China Food and Drug Administration (CFDA) released its “Principle of technical review of medical device software” (2015 Order No. 50). The principle, which is only available in Chinese, signals a major change for documentation requirements for stand-alone software or software components developed by medical device manufacturers or their development partners.
In a recent UL paper, Tim Lin, senior manager at UL Medical Regulatory Advisory Services (MRAS) in the Greater China Region, named inadequate design, processes that do not produce the required software documentation and worst of all, rejected applications as three of the most common results when manufacturers are unaware of changing global regulations.
To help medical device manufacturers interpret the new requirements and take necessary action, Lin explained the new principle in the UL paper and suggested three recommendations that device makers in China should follow when submitting documents for pre-market assessment.
Overview of Changes
The new regulation reflects CFDA’s current thinking and is based on the existing guidance from April 28, 2012. It provides more detail on the documentation requirements introduced therein, as well as the registration requirements for updated and revised software.
CFDA emphasizes its expectation that software safety and effectiveness is to be achieved by applying risk management, quality assurance and software lifecycle processes during software development. Off-the-Shelf (OTS) software which is part of the stand-alone software or component, or fully adopted OTS software used in medical devices are also subject to the new requirements set forth in 2015 Order No. 50.
To achieve Class A, B or C software safety classification, applicants must provide software descriptive documentation at the time of registration which should include the following elements:
· Basic Information – required information includes software identification, safety classification, architecture and design documents, hardware topology, runtime environment, indication, contraindication and registration history
· Implementation Process – required information includes development overview, risk management, requirement specifications, lifecycle, verification and validation, defect management, revision history and clinical evaluation
· Core algorithm
The software safety classification being applied for will determine the amount and detail of documentation required.
New Addition – Software Updates
Software updates must now be documented and reviewed by CFDA. The regulation distinguishes between major and minor updates, with major updates being those that impact medical device safety and effectiveness (e.g., adaptive maintenance, perfective maintenance, etc.) and minor updates being those with no impact. Device makers must submit major software updates as revisions to CFDA, while minor updates must be documented in the quality system, but need only be reviewed by CFDA at the time of license renewal or modification.
2015 Order No. 50 also outlines documentation requirements for software versions, OTS software and requirements for registering software and software components.
3 Tips From UL
As the risk of an adverse event to the Chinese population increases, CFDA responds by creating more stringent medical device regulations, including this one. With requirements covering a wide spectrum of device software, this new principle can be difficult to tackle. UL offers the following recommendations to fulfill 2015 Order No. 50:
· Implement software development processes that meet regulatory requirements during the product design stage
· Document all of the software development activities during the development phase
· Complete software documentation based on regulatory requirements when the design is completed
Ultimately, well-prepared software documentation driven by a robust software lifecycle process are the keys to reducing review times and gaining faster access to the medical device market.
With offices in 46 countries, UL is the global authority on product safety and conformance testing. UL’s team of experts is always ready to help regulated companies understand new regulatory requirements and reduce the burden on in-house regulatory affairs teams. Visit http://ul.com/to learn more.
Beth Pedersen is a marketing communications specialist at the MasterControl headquarters in Salt Lake City, Utah. Her technical and marketing writing experience in the enterprise software space includes work for Microsoft, Novell, NetIQ, SUSE and Attachmate. She has a bachelor’s degree in life sciences communication from the University of Wisconsin-Madison and a master’s degree in digital design and communication from the IT University of Copenhagen.