The scope of application and related policies for NMPA (National Medical Products Administration) certification of medical devices in China encompasses various categories, regulations, and guidelines that manufacturers must adhere to for obtaining certification. Below is a detailed overview:

1. Scope of Application

Categories of Medical Devices

Medical devices in China are classified into three categories based on risk level:

• Class I Devices: Low-risk devices that require general controls for safety and efficacy. Examples include simple surgical instruments.
• Class II Devices: Moderate-risk devices that require special controls in addition to general controls. Examples include infusion pumps and x-ray machines.
• Class III Devices: High-risk devices that require significant regulatory oversight and are subject to a more rigorous approval process. Examples include pacemakers and implantable devices.

Types of Medical Devices Covered

The scope of application for NMPA certification includes all types of medical devices, such as:

• In vitro diagnostic devices (IVDs)
• Surgical instruments
• Medical imaging devices
• Dental devices
• Rehabilitation and monitoring equipment
• Software as a medical device (SaMD)

2. Regulatory Framework and Policies

Key Regulatory Laws

The following laws and regulations govern the NMPA certification process for medical devices:

• Medical Device Supervision and Administration Regulations: This framework outlines the registration, post-market surveillance, and regulatory requirements for medical devices in China.
• Regulations on the Registration of Medical Devices: Provides detailed guidelines on the registration process, including the classification of devices, documentation required, and testing protocols.

Standards and Guidelines

Manufacturers must comply with various national and international standards, including:

• GB Standards: National standards (Guobiao standards) that cover the safety and performance of medical devices (e.g., GB 9706 for medical electrical equipment).
• ISO Standards: Compliance with International Organization for Standardization (ISO) standards, particularly ISO 13485 for quality management systems and ISO 14971 for risk management.

NMPA Guidelines

The NMPA publishes specific guidelines, which include:

• Technical Guidelines: Provide requirements for clinical evaluation, device testing, and risk management.
• Guidelines for Clinical Trials: Detailed instructions on conducting clinical trials for various medical devices.
• Guidelines for Quality Management Systems: Standards for implementing quality systems necessary for device manufacture and compliance.

3. Application Process

Pre-Market Registration

The registration process includes:

• Filing an Initial Application: Submission of documents and application forms to the NMPA.
• Technical Review: NMPA conducts a thorough review of the submitted documentation, including technical details, quality management systems, and clinical data.
• On-Site Inspections: For Class II and III devices, NMPA may conduct an on-site inspection of the manufacturing facility.

Clinical Evaluation and Testing

For more complex devices (Class II and III), manufacturers must conduct clinical evaluations, potentially including clinical trials. These evaluations must demonstrate the safety and effectiveness of the device before it can be marketed.

4. Post-Market Surveillance

Once certification is obtained, manufacturers must comply with post-market surveillance policies, which include:

• Monitoring the safety and effectiveness of the device.
• Reporting adverse events to the NMPA.
• Conducting regular audits and assessments of the quality management system.

5. Policies on Innovation and International Collaboration

The NMPA has policies that encourage innovation in medical technology and support international collaboration for medical device development and regulation. These include:

• Fast-Track Approval Pathways: NMPA offers expedited procedures for innovative products that meet specific criteria.
• Mutual Recognition Agreements: NMPA is working towards collaborations with other regulatory agencies (like the FDA and EMA) to streamline approval processes for devices already approved in other jurisdictions.

Conclusion

The scope of application for NMPA certification of medical devices in China is broad and encompasses various categories of products governed by a comprehensive regulatory framework. Understanding these policies and ensuring compliance is critical for manufacturers aiming to enter the Chinese market. Keeping abreast of the latest NMPA guidelines and engaging in regulatory preparedness can help streamline the certification process.

If you have specific questions about certain categories of devices or particular policies, feel free to ask!

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