ISO revises guidelines to address the risk management of medical devices

Overview: On December 18 of 2019, The International Organization for Standardization (ISO) presented their new and improved guidelines on medical devices ISO 14971, . The document instructs on the process of risk management for medical devices such as,  software as medical devices, in-vitro diagnostic devices and other products which might defer medical devices classification under some […]

CFDA New Clinical Data Requirements for Foreign medical devices

CFDA has proposed changes to Order 650 that would exempt additional types of Class II and III medical devices and IVDs from clinical trial requirements, and allow greater acceptance of clinical data from foreign countries in registration applications. The main changes to CFDA foreign clinical data acceptance criteria are as follows: Foreign clinical trials must […]