The regulatory standards and application conditions for NMPA (National Medical Products Administration) certified medical devices in China are crucial for ensuring that all medical devices meet safety, efficacy, and quality requirements before they can be marketed. Below is an overview of these standards and conditions:

1. Regulatory Standards

General Regulations

• Medical Device Supervision and Administration Regulation: This overarching regulation outlines the framework for the registration, production, and post-market surveillance of medical devices in China. It was revised in 2020 and emphasizes the importance of compliance with national standards.

Classification Standards

Medical devices in China are classified into three classes based on their risk levels:

• Class I: Low-risk medical devices that require general controls. They are subject to basic requirements that ensure safety.
• Class II: Moderate-risk devices that require special controls along with general manufacturing practices. These devices must demonstrate evidence of safety and effectiveness.
• Class III: High-risk devices that require extensive review, including clinical data and testing, due to their potential impact on health.

Chinese National Standards (GB Standards)

• These are mandatory standards published by the Standardization Administration of China (SAC) and cover various aspects of medical device design, manufacturing, and testing. Compliance with relevant GB standards is essential for NMPA certification. Examples include:
  • GB 9706: Medical electrical equipment standards.
  • GB/T 28001: Occupational health and safety management.

International Standards

• Compliance with relevant international standards is also encouraged, such as ISO 13485 (Quality Management Systems) and ISO 14971 (Risk Management), to facilitate faster approval processes and enhance global acceptability.

2. Application Conditions

Preliminary Requirements

• Company Registration: The manufacturer must be a legally registered entity in China or have a local representative in the country.
• Quality Management System Establishment: A robust QMS compliant with ISO 13485 must be in place, demonstrating the company's capability to consistently produce safe and effective medical devices.

Documentation Submission

The application must include several critical documents, including:

• Application Form: A completed application form specific to the type of device being registered.
• Technical Documentation: Detailed technical specifications, including device design, intended use, performance characteristics, and preclinical and clinical data (if applicable).
• Manufacturing Process Documents: Processes must be documented, including facility layouts, equipment used, and production workflow.
• Labels and Instructions for Use: Clear labeling and user instructions are required to ensure safe device use.

Clinical Data Requirements

• Class II & III Devices: For devices in these categories, manufacturers must provide clinical evaluation reports, which may require conducting clinical trials to support safety and efficacy claims. This includes obtaining ethical approvals and ensuring compliance with Chinese regulations regarding clinical trials.

Local Agent Requirement

• Foreign manufacturers must appoint a local agent who is responsible for liaising with the NMPA during the application process and in subsequent regulatory matters.

3. Application Process Overview

1. Preparation: Manufacturers must prepare their documentation and comply with quality management and regulatory requirements.
2. Submission: Applications are submitted through the NMPA online system or in person at designated offices.
3. Review Process: The NMPA conducts a thorough review, which may include requests for additional information or clarification.
4. On-Site Audit: For higher-class devices, an on-site inspection may occur to evaluate the manufacturing facility and processes.
5. Issuance of Certificate: If all requirements are satisfied and the device is deemed compliant, the NMPA issues the registration certificate, allowing for marketing in China.

Conclusion

The regulatory standards and application conditions for NMPA certification of medical devices in China are designed to ensure that all products meet high safety and efficacy standards. The process is thorough and requires extensive documentation, compliance with national and international standards, and a well-implemented quality management system.

If you have specific questions about particular types of devices or need more detailed information about the application process, please feel free to ask!

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