China’s NMPA Approves 277 Innovative Medical Devices

In recent years, China’s NMPA has been continuously promoting the innovation and development of the medical device industry. The NMPA has implemented a streamlined approval process for innovative medical devices, ensuring product safety, effectiveness, and quality control. This approach includes dedicated personnel, comprehensive guidance, and priority review, all while maintaining rigorous standards and procedures.

As of now, the NMPA has approved 277 innovative medical devices for market release. Notably, 27 of these approvals have occurred in 2024, encompassing a range of high-end medical devices such as bronchial navigation operation control systems, fundus imaging diagnostic software for retinal diseases, extracorporeal ventricular assist devices, and renal artery radiofrequency ablation instruments. These devices span multiple fields, including surgical robots, artificial intelligence medical devices, and cardiopulmonary support systems. The introduction of these innovative products provides patients with more treatment options, enhances the safety and success rate of surgeries, reduces treatment costs, and better meets the demand for advanced medical devices.

In 2024, the approved innovative medical devices include 5 non-active medical devices, 2 in vitro diagnostic reagents, and 20 active medical devices, covering 10 categories in the medical device classification. Among these, there is a significant number of active surgical and implantable devices, and 10 of the approved devices are imported.

Looking ahead, the NMPA will continue to align with technological advancements and industry development needs. It plans to introduce more specific supportive measures in key areas, comprehensively promoting the high-quality development of the medical device industry and ensuring a high level of safety for medical devices.

For companies looking to enter the Chinese medical device market, BradyKnows Medical is an elite team that offers expert guidance and support. With our deep understanding of the regulatory landscape and market dynamics, BradyKnows Medical can help navigate the complexities of the approval process, ensuring a smooth and successful market entry. For further inquiries regarding medical device registration, please contact: info@bradyknowsmedical.com.