In September 2018, China's National Medical Products Administration (NMPA) released two expanded lists - Medical devices & IVDs that are exempted from clinical trial requirements. As of current, there are 855 medical devices and 393 IVDs that are on the exemption lists. This move is part of China's aim to re-establish their stance on “the Opinion on Deepening the Reform of the Evaluation and Approval System and Encouraging the Innovation of Drugs and Medical Devices”, which aims to push for technological innovation in the country's medical industry, not only to boost their capability to attend to the citizens' healthcare needs but also to contest with other medically advanced nations.
In July 2018, NMPA has announced the adjustment of approval process for clinical trials to a 60-day window, which commences on the date of payment. Should there be no objections from the authorities during this duration, the applicant can proceed with the clinical trials.
For more information on the exemption list, check out the following link:
Currently, clinical trial requirements are only applicable to Class II and Class III medical devices that are not included on the exemption lists. ARQon has summarized the clinical trial process in a flowchart for easier reference.
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