A study report on eIFU to the Development Research Centre of the State Council

2023-06-20 | Beijing, Shanghai

On 20th June, the HCE Working Group, COCIR and CDMD Desk submitted a report on eIFUs to the Development Research Centre of the State Council (DRC) to support their research project and advocate for policy change to transition from paper-based IFUs to eIFUs.

The report summarises the current regulations in major global markets and compares them to the current regulations in mainland China. Additionally, the advantages of transitioning to eIFUs are discussed. In conclusion, improving the dissemination of medical device product information through information technology is an irreversible trend. However, regulatory authorities need to guide the transition from paper to electronic instructions and formulate technical specifications. Registrants should establish a lifecycle management process for electronic instructions, ensure accuracy, perform risk assessments and change controls, and maintain clear records. A validated operating environment and contingency plans for paper instructions during the transition period should also be prepared.

The DRC has received the report well.