In order to obtain NMPA (National Medical Products Administration) certification for medical devices in China, manufacturers must comply with a range of quality standards and compliance requirements. These standards ensure that medical devices meet safety, effectiveness, and performance criteria necessary for both approval and post-market surveillance in China. Below are the key quality standards and compliance requirements for NMPA-certified medical devices:

1. Quality Management System (QMS) Compliance

• ISO 13485:2016: This is the primary standard for medical device manufacturers and is required for NMPA certification. ISO 13485 outlines the requirements for a quality management system that must be implemented at every stage of the product lifecycle—from design and manufacturing to distribution and post-market activities.
  • Risk management (ISO 14971) is also a critical part of the QMS. This standard helps manufacturers assess and mitigate risks associated with their devices, which is a major part of NMPA’s regulatory evaluation.
  • The NMPA may require internal audits and external inspections to verify compliance with ISO 13485 during the registration process.

2. Product-Specific Chinese National Standards (GB Standards)

Medical devices sold in China must comply with the applicable GB standards, which are the Chinese national standards. These standards ensure that medical devices meet safety, performance, and quality benchmarks.

• GB 9706 Series: This includes standards for medical electrical equipment and medical devices, such as GB 9706.1 (Safety of Medical Electrical Equipment), GB 9706.3 (Electromagnetic Compatibility), and GB 9706.7 (Safety of In vitro Diagnostic Medical Devices).
• YY Standards: These are industry-specific standards that may be applicable depending on the type of medical device. For example, YY/T 0287 covers the sterility of medical devices.
• Product Testing: In addition to these standards, devices may need to undergo specific performance and safety testing according to the applicable GB or YY standards, such as electrical safety testing for medical equipment or biocompatibility testing for implants.

3. Product Technical Documentation (Technical File)

• Technical Documentation: Manufacturers must prepare a comprehensive technical file for NMPA registration. This file must include a range of documents to demonstrate compliance with relevant standards and regulatory requirements. Key documents include:
  • Product description and specifications (including design drawings, materials used, intended use)
  • Risk management reports (based on ISO 14971)
  • Clinical evaluation or clinical trial reports (if applicable)
  • Instructions for use and labeling (in Chinese)
  • Testing data (e.g., biocompatibility, EMC, electrical safety, and performance testing)
• Translation Requirements: All technical documentation and supporting materials must be translated into Chinese to meet NMPA’s regulatory language requirements.

4. Regulatory Testing and Performance Verification

• Biocompatibility Testing: Devices in direct contact with patients (e.g., implants, catheters) must undergo biocompatibility testing in accordance with ISO 10993 standards. This ensures that materials used in the device do not cause adverse biological reactions.
• Electrical Safety and EMC Testing: Electrical medical devices must meet GB 9706 standards for electrical safety and electromagnetic compatibility (EMC). The device must undergo performance and safety testing in accredited laboratories to ensure it operates safely and does not interfere with other electronic equipment.
• Sterilization Validation: Devices that require sterilization must comply with sterilization standards under YY/T 0287 and ensure proper validation and testing to demonstrate sterility.

5. Clinical Trials and Data Requirements

• Clinical Data Submission: For Class II and Class III medical devices (higher-risk devices), clinical trials may be required as part of the NMPA approval process. NMPA may request clinical trial data from Chinese patients or, in some cases, rely on international clinical data.
• Clinical Evaluation Report: A clinical evaluation report is required to summarize clinical trial data and evaluate the device’s safety and efficacy. This report must be in line with NMPA guidelines and may need to address any device-specific risks, especially for Class III devices.
• Ethical Approval: Clinical trials must receive approval from a Chinese Ethics Committee, and the study protocol must comply with Chinese regulations for ethical standards in clinical research.

6. Factory Inspection and Quality Control

• Manufacturing Facility Inspection: NMPA requires a site inspection of the manufacturing facility for Class II and Class III devices. This inspection ensures the facility complies with Good Manufacturing Practices (GMP) and relevant regulatory standards. For international manufacturers, the NMPA may send a representative or third-party auditor to conduct this inspection.
  • GMP for Medical Devices: Compliance with Good Manufacturing Practices (GMP) is mandatory, and manufacturers must demonstrate that their quality control systems are capable of consistently producing devices that meet safety and performance standards.
• Local Agent: Foreign manufacturers must appoint a local agent in China who acts as the liaison with NMPA and helps with communication, documentation submission, and inspection coordination.

7. Post-Market Surveillance (PMS) and Adverse Event Reporting

• Post-market Surveillance Requirements: After obtaining NMPA approval, medical device manufacturers must adhere to post-market surveillance requirements, including:
  • Adverse event reporting: Manufacturers must establish systems for monitoring and reporting any adverse events or device malfunctions.
  • Product recalls: If necessary, manufacturers must comply with NMPA’s guidelines on product recalls.
  • Annual reports: Some devices may require annual reports to NMPA, outlining performance, safety data, and any incidents or changes related to the product.
  • Periodic Review: NMPA may require periodic reviews of device performance and safety, especially for higher-risk devices (Class II and III).

8. Regulatory Fees

• Manufacturers are required to pay certain fees for the registration and certification process, including application fees, inspection fees, and fees for product testing or clinical trials, if applicable.

9. Labeling and Instructions for Use

• Chinese Labeling Requirements: All medical devices must have product labels and instructions for use in Chinese. This includes:
  • Device name, manufacturer details, and country of origin
  • Product description, indications, contraindications
  • Usage instructions and warnings
  • Expiration date, batch/lot numbers, and storage conditions
  • Regulatory certification number (e.g., NMPA registration number)
• Compliance with NMPA’s labeling guidelines is strictly enforced during product registration.

Conclusion

The process of obtaining NMPA certification for medical devices involves strict adherence to a variety of quality standards and regulatory requirements. Compliance with ISO 13485, GB/YY standards, and clinical data requirements is critical for successful registration. Manufacturers must also be prepared for facility inspections, post-market surveillance, and ongoing documentation updates. Working with a local agent and regulatory consultants with expertise in NMPA requirements can help ensure a smoother process and adherence to Chinese regulations.