2A-06 - Approval Time Lag of Innovative Medical Devices between China and the U.S.

Background: China has implemented policies to expedite imported innovative medical devices (IMD) approvals, aiming to promote simultaneous marketing of cutting-edge devices with significant clinical value since 2014. The IMD program waived the requirement of an approval certificate from a foreign authority when submitting marketing dossiers in China. While most IMDs in China were first approved in the U.S., the extent of the approval delay remains unclear.

Objectives: To quantify the approval lag for IMDs approved in both China and the U.S. since the launch of China’s IMD program.

Methods: We identified all IMDs approved in China from the National Medical Products Administration official website, extracting data on the device name, model and specifications, applicant, approval date, clinical evaluation approaches (exemption, comparison with an equivalent device, or clinical trials), and trial evidence (oversea or domestic). Corresponding U.S. approvals were identified in the Food and Drug Administration databases (510(k), PMA, and De Novo) by matching these details. The approval lag was calculated as the time difference between the approval dates in China and the U.S.

Results: A total of 39 imported IMDs were approved in China from 2019 to 2024, of which 36 were previously approved in the U.S. The overall median approval time lag was 911 (interquartile range [IQR]: 644-1801) days. No devices were exempted from clinical evaluation. Seven devices were approved via comparison with an equivalent device, with a median time lag of 644 [IQR: 638-644] days; Among devices requiring clinical trials, 19 devices relied on overseas trials (median lag 902 [IQR: 279-1319] days), while 10 devices conducted local trials or incorporated both oversea and domestic trials (median lag 1908 [IQR: 1801-3322] days).

Conclusions: Despite China’s expedited IMD approval reforms, the median approval delay for IMDs between China and the U.S. remained approximately 2.5 years, with especially longer delays for devices that conducted local clinical trials. To reduce approval lag, it is recommended that applicants proactively engage with Chinese regulatory authorities early in the development process, and design clinical trials that address demographic differences to minimize the need for additional local studies.