Comments on "Requirements to Registration Dossier for Medical Software" submitted to CMDE
2015-04-14 | Beijing, Shanghai
Medical Software consists of stand-alone software and software as an integral part of medical devices. Software plays an ever important role in complex medical equipment, hence the risks of software bugs may be higher than the risks of hardware failures. European companies recommend that requirements to registration of medical software in China follow best international practices. The EUCCC submitted a comprehensive list of comments to the future requirements to the registration dossier for medical software.
Link to the Call for Comments