China FDA has issued guidelines on registering medical device software that took effect this month that require detailed reporting as part of registration and supervision.
The Chinese-language notice for "Medical device software registration technical review guidelines" promulgated on Aug. 5, said that medical device manufacturers need to submit a software registration dossier and standardize technical review requirements of medical device software.
The CFDA, citing the promulgation order, said the aim is to "strengthen the medical device product registration work supervision and guidance to further enhance the quality of registration review."
Among areas noted are independent software and software components to devices policies for software updates, software upgrades version requirements and related issues, CFDA said.
In July, CFDA issued revised and final medical device classification rules set to go into effect at the start of next year. The final rules categorize the level of risk posed by devices by noting structural features, intended use, and whether they involve human contact. There are four primary categories for classification: passive, active, invasive, and reusable surgical devices, as well as a special classification category for combination devices.
- here's the release from CFDA (Chinese language)
- and the promulgation order (Chinese language)