For NMPA (National Medical Products Administration) certified medical devices in China, several key standards and guidelines are essential to ensure compliance and safety. Here are some of the important review standards and considerations:
1. Technical Review Standards
Device Classification: Devices are classified into Class I, II, or III based on risk and intended use, with higher classes requiring more stringent review processes.
Technical Documentation: Detailed technical files and design dossiers must demonstrate compliance with NMPA's technical standards and specifications.
Quality Management System (QMS): Manufacturers must adhere to ISO 13485 standards or equivalent, demonstrating effective implementation of QMS for design, production, and post-market surveillance.
Clinical Evaluation: For higher-risk devices (Class II and III), clinical evaluation reports and data are reviewed to assess safety and efficacy based on clinical trials or existing literature.
2. Testing Standards
Testing Requirements: Devices must undergo testing according to relevant Chinese national standards (GB standards) or international standards recognized by NMPA.
Types of Testing: This includes biocompatibility, electrical safety, performance testing, and any other specific requirements applicable to the device type.
3. Labeling and Instructions for Use (IFU)
Labeling Requirements: Clear and accurate labeling is crucial, with labels in Chinese that include essential information such as device specifications, usage instructions, and warnings.
IFU Requirements: Instructions for Use (IFU) must be comprehensive, accessible, and in Chinese, providing clear guidance on device operation, maintenance, and safety precautions.
4. Manufacturing and Production Standards
Manufacturing Requirements: Facilities must meet NMPA's standards for production processes, including cleanliness, equipment calibration, and personnel training.
Inspection and Compliance: On-site inspections may be conducted to verify compliance with production standards and QMS requirements, especially for Class II and III devices.
5. Post-Market Surveillance
- Monitoring and Reporting: Manufacturers are required to monitor device performance post-market, report adverse events promptly, and maintain records of device safety and effectiveness.
6. Regulatory Updates and Compliance
- Stay Informed: Manufacturers must stay updated on changes to NMPA regulations, guidelines, and standards to ensure ongoing compliance throughout the product lifecycle.
Key Considerations
Local Representation: Having a local agent or consultant familiar with NMPA regulations can facilitate communication and ensure compliance with local requirements.
Documentation Quality: Thorough and accurate documentation is essential for successful review and certification. All documents must be complete, well-organized, and compliant with NMPA standards.
Adhering to these review standards ensures that NMPA certified medical devices meet stringent regulatory requirements in China, promoting safety, efficacy, and quality in the healthcare market.
Contact Us：
Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn
Contact Us：
Whatsapp or Wechat：+86 15816864648；email address：htio.lin@grzan.cn
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