We had earlier reported on an emergency approval channel for NMPA approval of non-approved medical devices to combat COVID-19:
See China’s Coronavirus emergency response for urgently needed medical devices
The emergency channel could accelerate approval times for imported non-NMPA approved medical devices to as little as 5 days.
However, we have now confirmed that the emergency channel relating to COVID-19 response is no longer open due to the virus situation in China coming under control. Although no official announcement has been made by the NMPA to this effect, we had been corresponding with the NMPA on behalf of a number of clients and the NMPA has confirmed this to Cisema directly.
Some fast-track process remain, known as “Green Channel” approvals, but this is a narrow category for innovative products.
