China Adopts New Guidelines for Medical Device Software

August 14, 2015

The China Food and Drug Administration has released guidance on the registration of medical device software, paving the way for devicemakers to register software on a standalone basis.

In the past, medical software was registered as a component of a medical device, as there were no regulations for registering standalone software, says Ames Gross, president of Pacific Bridge Medical. The new guidance allows software to be registered and sold as standalone items.

The new policy provides a clearer path to registration and is likely to boost sales, Gross tells IDDM. It also means that some standalone software can be used by various companies on multiple devices, he adds.

The Aug. 5 guidance, which is meant to standardize the technical review requirements of medical device software, says companies should consider the software security level in combination with its intended use and core functions. Software is divided into three levels based on potential harm, with Grade A posing little to no harm, Grade B presenting a non-serious health risk and C potentially causing death or serious injury.

The document also provides an overview of basic information developers should include in the software description, such as model specifications and release version, the software security level, operating environment and any use restrictions.

The guidance also gives an overview of software development and information on risk management, verification and validation and defect management.

The CFDA says it will update content in the document as new regulations, standards and technical capacity become available.

Read the guidelines, in Chinese, at www.fdanews.com/081715-china-software.pdf. — Elizabeth Hollis