The National Medical Products Administration (NMPA) in China has implemented several updates and trends in recent years to streamline the regulatory process for medical devices. These changes aim to enhance safety, speed up market access, and ensure better alignment with international standards. Here are the latest changes and trends in NMPA certification for medical devices:

1. Streamlined Registration Process for Certain Devices

• Priority Review Pathways: The NMPA introduced a priority review pathway for innovative medical devices that meet the needs of public health or fill a gap in the domestic market. These devices may undergo an expedited review process, reducing approval times.
• Registration Timeline: While the overall timeline for registration has been shortened, the time for approval depends on the complexity of the device. For Class II and III devices, the NMPA has introduced more transparency into the timelines, with an expected registration time of 6 to 12 months for Class II and 12 to 18 months for Class III devices.

2. Accelerated Approval for Foreign Medical Devices

• Faster Approvals for Internationally Approved Devices: Devices that have already been approved by certain recognized authorities (like the FDA, EU, or Japan’s PMDA) may now benefit from an accelerated approval process in China. NMPA has shown increased willingness to accept clinical data from these jurisdictions for foreign manufacturers.
• Decreased Dependence on Local Clinical Trials: The NMPA has gradually relaxed the requirement for clinical trials for foreign medical devices if there is sufficient data from other markets. However, this may vary based on device classification and risk.

3. Increased Focus on Post-Market Surveillance

• Stricter Post-Market Monitoring: The NMPA has been focusing on improving post-market surveillance and vigilance, especially after high-profile product recalls in China. Manufacturers are now required to provide comprehensive post-market data to maintain their registration.
• Enhanced Adverse Event Reporting: The system for reporting adverse events (AE) has been enhanced, requiring manufacturers to report incidents in a timely manner. There is also increased scrutiny of the post-market surveillance activities of foreign companies selling in China.

4. Focus on Quality Control and Compliance

• Good Manufacturing Practices (GMP): NMPA requires medical device manufacturers, both domestic and international, to comply with local GMP regulations. They have heightened enforcement on the necessity for local GMP certification, including the implementation of China’s Good Manufacturing Practice for Medical Devices (GMP-MD).
• Inspection and Audits: NMPA inspectors have been increasingly active in auditing both domestic and foreign manufacturing facilities to ensure compliance with GMP. These audits are comprehensive and now involve more stringent documentation review, manufacturing processes, and quality control measures.

5. Shift Towards Digitalization and E-Submission

• NMPA’s E-Submission System: The NMPA has transitioned to an entirely digital submission process for medical devices, enabling quicker approval times and more efficient processing of applications. This includes electronic submissions of registration dossiers, clinical trial data, and post-market reports.
• Data Privacy and Security Requirements: With the digitalization of the regulatory process, manufacturers must comply with China’s stringent data security laws. The Data Security Law and Personal Information Protection Law (PIPL) are relevant for companies, as they need to ensure compliance when submitting data for approval and post-market surveillance.

6. Increased Focus on Safety and Efficacy

• Enhanced Clinical Trial Requirements: For certain high-risk devices, the NMPA has implemented stricter requirements for clinical trials, particularly for devices involving new technologies, novel materials, or those that have high risks associated with their use.
• More Specific Guidelines for Class III Devices: The NMPA continues to refine the guidelines for Class III medical devices, which require a more rigorous testing process compared to Class I and II devices. This includes comprehensive risk assessments and robust efficacy testing to ensure safety before the devices can enter the market.

7. Regulatory Harmonization with International Standards

• Conformance to ISO Standards: There is an ongoing effort by the NMPA to align more closely with international standards such as ISO 13485 (for quality management systems) and ISO 14971 (for risk management). This trend is part of China’s commitment to integrating more with global regulatory frameworks.
• CE and FDA Approvals Considered Favorably: Devices that have obtained CE Marking or FDA clearance are being given more favorable treatment in China. NMPA now tends to accept international clinical trial data and documentation from these agencies, although Chinese-specific testing may still be required in some cases.

8. Simplification of Registration for Certain Lower-Risk Devices

• Class I Medical Devices: The process for registering Class I devices (low-risk) has been simplified. Manufacturers can now use a simplified notification procedure, without needing to submit as much supporting documentation or undergo as stringent testing requirements.
• Self-Declaration for Class I Devices: For some low-risk devices, the NMPA has introduced a self-declaration process where the manufacturer can declare compliance with relevant standards instead of submitting a complete registration application.

9. Tighter Control on Import and Distribution

• Importer Licensing: Importers and distributors must meet strict requirements, including compliance with NMPA’s licensing system. Importers are also expected to adhere to the same regulatory standards as the manufacturers of the devices.
• Requirements for Local Representation: Foreign manufacturers must have a local agent or representative in China to act as the point of contact with NMPA and manage any regulatory communications.

10. Emerging Trends in Digital Health and AI

• Approval of AI Devices: The NMPA is increasingly focusing on artificial intelligence (AI)-enabled medical devices and digital health tools. There has been significant progress in the regulatory framework for AI-based diagnostic tools and software as medical devices (SaMD).
• Special Guidelines for Digital Health: The NMPA has started issuing more specialized guidelines for the approval of software, apps, and devices that rely on AI and machine learning to diagnose or treat medical conditions.

Conclusion

NMPA certification for medical devices in China is evolving towards greater efficiency, transparency, and alignment with global standards. The agency has made significant strides in enhancing its processes for approving innovative medical technologies, particularly through the prioritization of certain devices, the acceptance of international clinical data, and the digitization of regulatory procedures. However, manufacturers must remain vigilant regarding stringent local requirements and continue to ensure compliance with China’s growing focus on post-market surveillance, safety, and efficacy.