The National Medical Products Administration (NMPA) has released its 2023 medical device filings work report, detailing the review and approval processes over the past year. In 2023, the NMPA received 13,260 applications for initial registration, renewal registration, and change registration of medical devices, representing a 25.4% increase from 2022. The bureau approved a total of 61 innovative medical devices, including 12 priority approvals, marking a record high—an increase of six approvals from the previous year.
The approved novel medical devices showcase enhanced innovation, with the disposable circular pulmonary artery radiofrequency ablation catheter for treating pulmonary hypertension being the first of its kind approved in China. Other world-class technologies approved this year include single photon emission and X-ray computed tomography imaging systems, intraperitoneal endoscopic single hole surgical systems, and intracranial thrombectomy stents.
Among the top five registered domestic Category III medical devices are passive implantable devices, neurological and cardiovascular surgical devices, infusion, nursing and protective devices, active surgical devices, and medical imaging devices. Active surgical instruments experienced the most significant growth, with a 54% annual increase in registrations, surpassing medical imaging instruments. Registrations for other categories also rose, including a 26.2% increase in infusion, nursing, and protective instruments, an 11% rise in neurological and cardiovascular surgical instruments, and an 18.8% uptick in passive implanted instruments.
In terms of imported devices, the top five registered categories are passive implantable devices, dental devices, ophthalmic devices, medical imaging devices, and active surgical devices. Notably, ophthalmic devices have surged past infusion, nursing, and protective devices, while active surgical devices have outpaced neurological and cardiovascular surgical devices. Registrations of passive implantable devices rose by 43.3%, and dental devices saw a 57.8% increase, although registered medical imaging devices declined by 44.2%.
Throughout 2023, the NMPA continued its adherence to the Special Review Procedure for Innovative Medical Devices and the Priority Approval Procedure. A total of 466 special approval applications for innovative medical devices were received, reflecting a 35.9% increase from 2022, with 69 applications approved for the special review process.
From 2014 to 2023, the NMPA has approved a total of 250 innovative medical devices, involving 167 domestic enterprises across 16 provinces and 18 international enterprises from five countries.- Flcube.com
