Feedback on Call for Comments of Implementation Guidelines for Medical Device Recall in Shanghai (Draft)

2023-09-08 | Beijing, Shanghai

On 8 September, Healthcare Equipment (HCE) Working Group, COCIR Post Market Surveillance Task Force, and Consumable and Disposable Medical Device Regulatory Affairs Advisory Committee submitted the feedback of the call for comments "Implementation Guidelines for Medical Device Recall in Shanghai (Draft)" to Shanghai Medical Products Administration (SMPA).

The key messages were issues related to coordination during the actual recall process, communication challenges, and the clarity of responsibilities and obligations. To enhance the "Implementation Guidelines for Medical Device Recall in Shanghai," several recommendations and suggestions were proposed, emphasising the need for clear articulation, improved communication mechanisms, and the explicit delineation of responsibilities and obligations. These inputs have been incorporated into the revision process of the guidelines to enhance their accuracy and practicability.