NMPA Releases 2024 Annual Medical Device Registration Work Report

On February 13, 2025, China's National Medical Products Administration (NMPA) released the "2024 Annual Medical Device Registration Report." This report offers a comprehensive summary of the registration outcomes and progress in 2024, providing valuable insights for overseas and domestic medical device manufacturers. It aims to strengthen medical device supervision, ensure product quality and safety, and promote technological innovation and international alignment.

Medical Device Registration Work

10 initiatives undertaken by NMPA in 2024 with respect to medical device registration work were:

1. Steady Progress in Medical Device Regulatory System Construction

• In 2024, the NMPA completed the "Draft Medical Device Management Law" after thorough research and wide-ranging solicitation of opinions. This legislation provides a robust legal framework for advancing China's transformation from a major medical device manufacturing country to a global leader. The new law is expected to be implemented later this year. Additionally, the "Trial Measures for the Supervision and Inspection of Medical Device Clinical Trial Institutions" and inspection criteria were issued to strengthen clinical trial management.

2. Continuous Growth in Approved Innovative Medical Devices

• In 2024, the NMPA approved 65 innovative medical devices and 8 priority-review medical devices. These innovative products cover various fields, including surgical robots, cardiopulmonary support systems, and artificial intelligence, offering more treatment options and enhancing the safety and success rates of clinical surgeries.

3. Implementation of National Key Regional Strategies

• Significant support was extended to key regions such as the Guangdong-Hong Kong-Macao Greater Bay Area, Hainan Free Trade Port, and Fujian. Three pilot products for clinical real-world applications in Hainan were approved, bringing the total number of approved products to 12 by the end of 2024, benefiting more patients.

4. Standardization of Medical Device Registration and Filing Management

• The NMPA conducted research on registration management and organized seminars to maintain the order of registration and filing work. Discussions focused on the challenges and trends in registration management.

5. Gradual Improvement of Registration Risk Prevention Mechanisms

• Quarterly meetings were held to assess registration and filing risks, with a focus on categorization, attribution, and compliance issues. By the end of 2024, 1,498 clinical trial institutions had been registered, reflecting intensified oversight.

6. Accelerated Enhancement of Medical Device Evaluation and Approval Capabilities

• The NMPA organized evaluations of provincial medical device evaluators and institutions to boost evaluation and approval capabilities. Training sessions, both online and offline, were conducted, reaching a total of 11,300 participants.

7. Strengthening of Medical Device Standards System

• In 2024, 100 industry standard revision projects were launched, and 90 medical device industry standards were approved and released. Additionally, 33 national standard revision projects were greenlit, with 49 medical device national standards issued.

8. Further Refinement of Medical Device Classification Management

• The "In Vitro Diagnostic Reagent Classification Catalogue" was revised, establishing 25 primary and 1,852 secondary product categories. Guidance principles for the classification and definition of hot topic products, such as myopia control and nanomaterial - based medical devices, were also developed.

9. Advancement of Regulatory Science Research

• Research was conducted on nine key pre-market projects for medical devices, including new-generation gene sequencing product evaluation methods and digital therapy medical device quality evaluation methods, involving 45 subprojects.

10. Substantive Progress in International Exchange and Cooperation

• Efforts were intensified to promote the development of the Global Harmonization Working Party (GHWP). Strategic advisory, capacity-building, and review-trust-based special working groups were established to enhance organizational vitality.

Medical Device Registration Application Acceptance

In 2024, NMPA received a total of 13,828 applications for initial registration, renewal registration, and change registration of medical devices, with an increase of 4.3 percent compared to 2023.

1. Overall Situation

• Domestic Class III Medical Devices: 7,600 applications accepted, a 7% increase from 2023.
• Imported Medical Devices: 6,228 applications accepted.

2. Breakdown by Category

• Domestic Class III Medical Device Registration Acceptance: 7,600 applications, up 7% from 2023.
• Imported Class II Medical Device Registration Acceptance: 3,295 applications, up 8.5% from 2023.
• Imported Class III Medical Device Registration Acceptance: 2,933 applications, down 5.9% from 2023.

Medical Device Registration Approvals

In 2024, the NMPA approved a total of 13,133 first registrations, renewal registrations, and change registrations for medical devices, with a 7.5% increase in the total number of registration approvals compared to 2023.

1. Overall Situation

• Domestic Class III Medical Devices: 6,886 items approved.
• Imported Medical Devices: 6,247 items approved.

2. Breakdown by Category

• Domestic Class III Medical Device Registration Approval: 6,886 items.
• Imported Class II Medical Device Registration Approval: 3,228 items.
• Imported Class III Medical Device Registration Approval: 3,019 items.

3. Monthly Approval Trends for Initial Registrations

• The monthly approval trends for initial registrations in 2024 showed a sustained increase in the number of innovative medical device products approved.

4. Analysis of Approved Product Categories

• Domestic Class III Medical Devices: Products covered 18 sub - directories of the "Medical Device Classification Catalogue," excluding in vitro diagnostic reagents. The top five categories were: passive implantable devices, neuro and cardiovascular surgical instruments, active surgical instruments, infusion, care, and protective instruments, and dental instruments.
• Imported Medical Devices: Products covered 21 subdirectories of the "Medical Device Classification Catalogue," excluding in vitro diagnostic reagents. The top five categories were: passive implantable devices, dental instruments, active surgical instruments, ophthalmic instruments, and active implantable instruments.

5. Country-wise Breakdown of Imported Medical Devices

• Products from 33 countries and regions were approved in China in 2024. The top five countries in terms of first-time registration of imported medical devices were the United States, Germany, Japan, South Korea, and France.

6. Provincial Analysis of Domestic Class III Medical Device Registrations

• Registrations for domestic Class III medical devices were concentrated in economically developed coastal provinces. The top five provinces for initial registrations of domestic Class III medical devices were Jiangsu, Guangdong, Beijing, Shanghai, and Zhejiang.

Registration and Approval of Innovative and Priority: Reviewed Medical Devices

In 2024, the NMPA continued to review products under the "Special Review Procedure for Innovative Medical Devices" and the "Priority Approval Procedure for Medical Devices," receiving 451 applications for innovative medical device special approvals, a decrease of 3.2% from 2023.

1. Innovative Medical Devices

The approved innovative medical devices in 2024 were primarily concentrated in the following technical fields:

• Cardiovascular and Electrophysiology Technologies: Products such as cardiac pulse field ablation catheters and related systems were approved. These technologies treat arrhythmias using non - thermal ablation methods, with clinical data showing an over 50% reduction in complications compared to traditional methods.
• Artificial Intelligence and Imaging - assisted Diagnosis: Multiple cranial aneurysm CT angiography assistance software products were approved, with algorithms achieving a lesion recognition accuracy of ≥95%.
• Minimally Invasive Surgery and Robotic Technologies: Several bronchoscopes navigation operation control systems and related instruments were approved, reducing the operation time for complex endoscopic surgeries by 30%.
• Extracorporeal Life Support and Critical Care Devices: Short - term extracorporeal ventricular assist devices and related consumables were approved, providing transitional treatment for heart failure patients.

2. Priority Reviewed Medical Devices

In 2024, eight priority - reviewed products were approved, focusing on solving major disease diagnosis and treatment challenges:

• Cancer Early Screening and Companion Diagnostics: Exosome - based biomarker detection kits achieved an 89% sensitivity for ovarian cancer early screening.
• Infectious Disease Control: High - sensitivity HBV RNA detection kits set new standards for hepatitis B treatment monitoring.
• High end Treatment Systems: Domestic heavy ion radiotherapy equipment was approved, offering more accessible precision radiotherapy options for cancer patients.

Impact and Recommendations for Overseas Manufacturers

1. Market Access

• The new plan further relaxes foreign capital entry restrictions, creating more space for overseas medical device manufacturers to enter the Chinese market. Enterprises should actively assess whether their products meet the needs and standards of the Chinese market and prepare for market access in advance.

2. Investment Promotion

• The government has increased support for foreign - funded enterprises, including tax incentives and financial assistance. Enterprises can use these policies to reduce investment costs and increase returns.

3. Service Guarantee

• The new plan emphasizes the service guarantee for foreign - funded enterprises, including financing support and facilitation of personnel exchanges. Enterprises can fully utilize these facilitation measures to optimize operational efficiency.

4. Compliance Requirements

• Despite policy relaxation, enterprises must still comply with relevant Chinese laws and standards. It is recommended that enterprises strengthen cooperation with professional consulting agencies to ensure compliance.

5. Market Expansion

• With the increasing demand for high - end medical devices in the Chinese market, enterprises can leverage the opportunities brought by the new plan to expand their product lines and meet market demand.

Future Trends

• Artificial Intelligence and Telemedicine: As algorithm transparency and cybersecurity reviews become stricter, enterprises need to strengthen data governance and explainability research, and strategically deploy multi-center clinical validation in advance.
• Green Medical Technologies: NMPA has proposed encouraging the application of biodegradable materials. Products such as biodegradable stents and eco - friendly consumables will receive preferential review.
• Real-World Evidence (RWE) Application: High-risk devices are allowed to supplement clinical trials with real-world data, and international companies can rely on China's medical database to accelerate the expansion of indications.

Further Information

To read the original NMPA released 2024 Annual Medical Device Registration Work Report, please click here.

The "2024 Annual Medical Device Registration Report" offers significant policy support and facilitation measures for foreign - funded enterprises in the Chinese market, aiming to create a fairer, more transparent, and predictable business environment. For overseas medical device manufacturers, this is a crucial opportunity to enter or expand their presence in the Chinese market. Cisema, as a professional regulatory consulting company, will continue to monitor policy developments and provide the latest policy interpretations and compliance recommendations to help you better grasp the opportunities in the Chinese market.