Summary Of 2023 China NMPA Medical Device Registration Work Report
2024-02-26
NMPA has summarized its work on all medical devices in 2023, which includes medical device registrations, acceptance of applications for medical device registrations, and approvals of medical device registrations, as set out below:
Medical Device Regulatory Framework:
The regulatory framework for medical devices saw significant improvements, with the National People’s Congress including the “Medical Device Management Law” in the legislative plan.
Collaboration with the National Health Commission and the National CDC resulted in the issuance of emergency management regulations for medical devices and temporary import requirements for urgently needed medical devices.
Innovation in Medical Devices:
Approval for innovative medical devices reached a record high, with 61 approvals granted in 2023.
The quality and quantity of innovative medical devices increased, meeting international standards and public demand for high-end medical equipment.
Strategic Initiatives:
Support was provided for key regional development initiatives, including projects in the Beijing-Tianjin-Hebei region, the Yangtze River Delta, and the Guangdong-Hong Kong-Macao Greater Bay Area.
Initiatives like the Boao International Medical Device Real World Research Conference were guided, facilitating regional healthcare needs with advanced medical equipment.
Improvements in Registration Management:
Notable enhancements were made in the management of medical device registration, including the issuance of regulations and guidelines to standardize registration requirements.
Quality Standards Enhancement:
Various documents were published to refine the management of medical device standards, ensuring precision in standard formulation and revision.
Progress in Classification Management:
Efforts were made to strengthen the classification management of medical devices, with adjustments made to classification catalogs and the establishment of specialized working groups.
Implementation of Unique Identification:
The implementation of unique identification for medical devices proceeded systematically, with the inclusion of high-risk medical devices in the third phase of implementation.
Technical Review Capacity Enhancement:
Continuous improvement was observed in the technical review capacity for medical devices, integrating quality management systems efficiently.
Acceptance of Registration Applications:
The NMPA received a total of 13,260 medical device registration applications in 2023, marking a 25.4% increase compared to 2022.
Approval of Registration Applications:
A total of 9,968 medical device registration applications were accepted, including 6,154 applications for import medical devices.
Innovation Product Registration and Approval:
The NMPA received 466 applications for innovative medical device special review, of which 69 were approved for further review.
61 innovative medical device products were approved for market entry in 2023.
The year 2023 witnessed significant strides in the regulation and management of medical devices in China, with a focus on innovation, safety, and regional healthcare development. These efforts are vital for ensuring public health and advancing the country’s medical technology sector.
