The scope of application and implementation requirements for NMPA (National Medical Products Administration) certification of medical devices in China depend on several factors, including the classification of the device and its intended use. Here are the key aspects to consider:

1. Device Classification: Medical devices in China are categorized into Classes I, II, and III based on their risk level. The classification determines the regulatory pathway, requirements for testing, clinical evaluation, and documentation.

2. Regulatory Pathways:

   • Class I Devices: Typically low-risk devices that may only require basic registration and self-declaration of conformity with applicable standards.
   • Class II Devices: Moderate-risk devices that require technical review and testing by NMPA-designated testing laboratories.
   • Class III Devices: High-risk devices that necessitate comprehensive clinical evaluations, rigorous testing, and scrutiny by NMPA experts.

3. Technical Documentation: Manufacturers must prepare detailed technical documentation demonstrating compliance with Chinese regulatory requirements. This includes information on device design, materials used, manufacturing processes, performance testing data, and risk management.

4. Clinical Evaluation: For Class II and Class III devices, clinical data and evaluations may be required to demonstrate safety and efficacy. This involves conducting clinical trials or referencing existing clinical data, depending on the device's novelty and risk level.

5. Testing Requirements: Devices must undergo testing according to relevant Chinese national standards or international standards accepted by China. Testing is conducted by NMPA-accredited laboratories to verify compliance with safety, performance, and quality standards.

6. Quality Management System (QMS): Manufacturers must implement a QMS compliant with ISO 13485 or an equivalent standard. The QMS should cover design controls, production processes, risk management, and post-market surveillance.

7. Labeling and Instructions for Use: Devices must be labeled in Chinese with essential information such as device specifications, manufacturer details, intended use, and warnings. Instructions for use must be clear and comprehensive.

8. Post-Market Surveillance: Manufacturers are required to establish post-market surveillance systems to monitor device performance, identify potential issues, and report adverse events to NMPA as per regulatory requirements.

9. Local Representation: Non-Chinese manufacturers must appoint a local authorized representative in China responsible for regulatory compliance and communication with NMPA.

10. Renewal and Amendments: Certificates issued by NMPA are typically valid for a certain period and may require renewal. Any changes to the device design, manufacturing process, labeling, or intended use must be approved by NMPA.

11. Authorized Use: NMPA certification allows devices to be legally marketed and used in China for their intended purposes, ensuring compliance with local regulations and standards.

Navigating the NMPA certification process requires careful attention to these requirements and may involve collaboration with regulatory experts familiar with Chinese medical device regulations. Each step must be meticulously followed to ensure successful certification and market entry in China.

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