Yes, medical devices typically need to undergo on-site inspection and evaluation as part of the NMPA (National Medical Products Administration) registration process in China, particularly for Class II and Class III devices. Here’s a breakdown of why on-site inspections are generally required and what they entail:

### 1. **Importance of On-Site Inspection**

   - **Verification of Compliance**: On-site inspections are conducted to verify that the manufacturer complies with the relevant regulations and quality standards, including ISO 13485 requirements for quality management systems.

   - **Quality Assurance**: Inspections help ensure that the manufacturing processes, facilities, and equipment used to produce the medical devices meet safety and performance standards, ultimately safeguarding public health.

### 2. **Scope of Inspection**

   - **Manufacturing Facilities**: Inspectors typically review the entire manufacturing facility, including production areas, sterilization protocols, storage conditions, and quality control labs.

   - **Document Review**: Inspectors will examine documentation related to operational procedures, quality control measures, and records of manufacturing and testing.

   - **Interviews**: The inspection may involve interviews with key personnel to assess their understanding of quality management practices and compliance with regulatory requirements.

### 3. **Classification Matters**

   - **Class I Devices**: For Class I devices, the registration process is generally simpler and may not require on-site inspection, as these devices are considered low-risk. However, manufacturers must still adhere to basic quality management practices.

   - **Class II and III Devices**: On-site inspections are almost always required for Class II and Class III devices due to their higher risk profiles. This is especially true if the device is novel or particularly complex.

### 4. **Inspection Scheduling and Preparation**

   - **Advance Notice**: The NMPA usually provides advance notice for inspections. Manufacturers should prepare all necessary documentation and ensure facilities are inspection-ready.

   - **Acceptance Criteria**: The inspection is based on specific acceptance criteria laid out in applicable standards and regulations.

### 5. **Post-Inspection Outcomes**

   - After the inspection, the NMPA will review the findings. If the manufacturer meets the required standards, the application for registration may proceed to the next steps; if not, the manufacturer may need to address deficiencies before approval can be granted.

### Conclusion

On-site inspections are a critical component of the NMPA registration process for medical devices, especially for those classified as Class II and Class III. These inspections serve to protect public health by ensuring that only safe and effective medical devices reach the market. If you need further clarification about the inspection process or any specific requirements, feel free to ask!

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