Yes, NMPA (National Medical Products Administration) registration in China does indeed involve compliance verification at several stages of the process. Compliance verification is a critical aspect of the regulatory procedure to ensure that medical devices meet the safety, effectiveness, and quality standards set by Chinese regulations. The goal is to confirm that both the manufacturer and the product are fully aligned with Chinese laws and industry standards.

Key Aspects of Compliance Verification in NMPA Registration:

1. Manufacturing Facility Compliance

Before a medical device can be registered with the NMPA, the manufacturing facility undergoes verification to ensure that it complies with Good Manufacturing Practices (GMP). This involves:

• Facility Inspection: NMPA may require an on-site inspection of the manufacturing facility, especially for Class II and Class III devices, and sometimes for high-risk Class I devices. This inspection verifies that the facility adheres to international GMP standards (e.g., ISO 13485), which ensures that medical devices are produced under controlled and consistent conditions.
• Quality Management System (QMS): The manufacturer’s quality management practices are verified to confirm they comply with relevant standards. The NMPA may check that the manufacturer has a QMS in place to ensure product consistency, safety, and traceability.
• Documentation Review: NMPA will review various manufacturing and quality control documents to verify that processes such as testing, production, and storage meet regulatory expectations.

2. Compliance with Chinese Standards (GB Standards)

NMPA requires that the medical device complies with Chinese national standards known as GB standards. The device must be tested and verified to ensure it meets the following:

• Safety: This includes verifying electrical safety, fire safety, mechanical safety, and electrical hazards, especially for devices like diagnostic equipment or surgical instruments.
• Performance: The device must be able to perform its intended function consistently and safely. Performance standards vary depending on the device type.
• Biocompatibility: For devices that come into contact with the human body, such as implants or diagnostic devices, biocompatibility testing is required to confirm that the device does not cause harmful reactions.
• EMC (Electromagnetic Compatibility): Devices that are electrical in nature must meet the required EMC standards to prevent interference with other electronic equipment.

The device is tested by either an NMPA-approved testing center or a third-party laboratory that complies with Chinese standards.

3. Clinical Trial Compliance

For some Class II and III devices, compliance verification also includes the review of clinical trial data to confirm that the device is safe and effective for its intended use in the Chinese population. The compliance process involves:

• Clinical Trial Application: If clinical trials are required, the manufacturer must submit an application for approval of the clinical trial to the NMPA. This application must include details about the trial design, methodology, and safety assessments.
• Review of Clinical Data: After the trials are completed, NMPA evaluates the clinical data to ensure that the device performs as intended and does not pose any safety risks. This evaluation includes checking whether the clinical trials follow international good clinical practice (GCP) guidelines.
• Clinical Evaluation Report (CER): For some devices, especially those that do not have sufficient trial data or clinical history from other markets, a clinical evaluation report may be required, which assesses the safety and performance based on available clinical literature or previous studies.

4. Compliance with Labeling and Documentation Requirements

Another essential aspect of compliance verification involves ensuring that all product labeling and instructions for use (IFU) meet NMPA’s requirements. Key points of compliance include:

• Chinese Language Requirement: All labeling, packaging, and user manuals must be provided in Chinese. This includes Instructions for Use (IFU), which must clearly describe the device's purpose, risks, warnings, usage, and handling instructions in compliance with NMPA regulations.
• Content Verification: The content of the labeling must be accurate and in line with NMPA guidelines. This includes product names, manufacturing information, indications, warnings, and regulatory compliance marks. NMPA ensures that these labels are clear, accurate, and do not mislead users.

5. Compliance with ISO and International Standards

Although ISO 13485 is not a mandatory requirement for NMPA registration, manufacturers who have ISO 13485 certification (the international standard for quality management systems in the medical device industry) may have an easier time demonstrating their compliance with regulatory requirements.

• ISO Certification: NMPA will verify whether the manufacturer adheres to ISO 13485, which is crucial for ensuring that the company follows best practices for producing medical devices. This verification can speed up the registration process, especially for foreign manufacturers.
• International Compliance History: NMPA may also review the regulatory history of the medical device in other markets, particularly in jurisdictions like the EU (CE-marking), U.S. (FDA approval), or Japan (PMDA approval). A positive history of compliance in these markets can help streamline the verification process, although it does not guarantee approval in China.

6. Verification of Adverse Event History and Recalls

As part of the compliance verification process, NMPA may also review the manufacturer’s adverse event history and product recalls from other markets, especially if the device has been previously marketed internationally. If there have been any significant safety concerns or recalls, the NMPA will verify whether these issues have been addressed adequately.

• Post-Market Surveillance: NMPA also checks the manufacturer's procedures for post-market surveillance. If the device is approved, the manufacturer must adhere to local regulations on monitoring the device's performance and handling adverse events in China.

7. Third-Party Verification

In some cases, NMPA may require third-party verification of compliance, especially for manufacturers based outside of China. This could involve:

• Third-Party Audits: For foreign manufacturers, a Chinese agent may be responsible for facilitating compliance with local regulations. NMPA may require audits by accredited third-party organizations to verify that the foreign manufacturer adheres to the same standards as domestic manufacturers.
• Third-Party Testing: For certain devices, NMPA may allow or even require testing by third-party laboratories to ensure compliance with safety and performance standards. These labs must be recognized by NMPA.

Conclusion

The NMPA registration process in China is highly focused on compliance verification to ensure that medical devices meet Chinese standards for safety, quality, and efficacy. Manufacturers must comply with local regulations, international standards, and specific NMPA requirements regarding manufacturing practices, clinical trial data, product performance, labeling, and post-market surveillance. Compliance verification is carried out through documentation review, facility inspections, product testing, clinical evaluations, and third-party audits to confirm that the device can be safely marketed in China.