In China, the safety of medical devices is a primary concern during the National Medical Products Administration (NMPA) certification process. The NMPA ensures that medical devices meet rigorous safety standards before they are allowed on the market. The requirements for safety are comprehensive and cover several key aspects, including compliance with national standards, risk management, clinical evaluation, and post-market surveillance. Below is an outline of the main safety requirements for medical devices undergoing NMPA certification:

1. Compliance with National Standards (GB Standards)

Medical devices in China must comply with the Guobiao (GB) standards, which are the national safety and technical standards set by the Chinese government. These standards cover various aspects of medical device safety, including:

• GB 9706 series: This series of standards addresses the safety and performance of medical electrical equipment. It includes requirements for electrical safety, mechanical safety, thermal safety, and protection against electric shock.

  • GB 9706.1: General requirements for safety.
  • GB 9706.3: Electromagnetic compatibility (EMC) requirements.
  • GB 9706.10: Requirements for medical device software safety.

• GB/T 16886 series: These standards pertain to biological evaluation of medical devices and include requirements for biocompatibility, such as testing for cytotoxicity, sensitization, and irritation. Devices in contact with the human body must undergo these tests to ensure they do not pose health risks.

• GB/T 20670: Standards for sterilization and microbiological testing of medical devices.

Compliance with these standards is often required as part of the technical documentation submitted during the NMPA registration process.

2. Risk Management and Safety Assessment (ISO 14971)

In addition to complying with Chinese GB standards, manufacturers must perform a risk management process according to ISO 14971 (or equivalent). This process helps identify and evaluate potential hazards associated with the device, and includes:

• Risk analysis: Identifying potential risks throughout the device lifecycle (e.g., design, production, and use).
• Risk evaluation: Evaluating the probability and severity of identified risks.
• Risk control: Implementing measures to control or mitigate risks, such as design changes, safety features, or warnings.
• Residual risk assessment: Ensuring that any remaining risks are acceptable and do not compromise patient safety.
• Risk documentation: Manufacturers must provide evidence of the risk management process and demonstrate that safety risks have been minimized.

3. Clinical Safety Evaluation

For certain Class II and Class III devices, particularly those with new technologies or high risk, a clinical evaluation is required to demonstrate the safety and performance of the device. The evaluation may include:

• Clinical trials: Conducting studies in China or using existing clinical data to assess the device's safety and effectiveness.
• Post-market clinical surveillance: Ongoing monitoring of device performance after market entry.

The clinical evaluation report must include data on potential adverse events, device performance, and patient safety. If a device is similar to one already on the market, clinical data may be used to demonstrate safety by comparison.

4. Product Testing

Before submitting the registration application, medical devices are often subjected to a variety of safety tests, depending on the type of device and its intended use:

• Electrical Safety Testing: Devices that involve electrical components (e.g., diagnostic equipment, therapeutic devices) must pass electrical safety tests to prevent hazards like electric shock or fire. Compliance with GB 9706.1 is required, and testing may involve high-voltage testing, insulation resistance, and grounding requirements.

• Mechanical Safety Testing: For devices that involve moving parts or mechanical components (e.g., infusion pumps, surgical instruments), mechanical safety must be ensured. Testing includes checking for stability, durability, and failure modes.

• Biocompatibility Testing: As outlined by ISO 10993, medical devices that come into contact with human tissue must be tested for biocompatibility. This includes testing for cytotoxicity, sensitization, and irritation. Devices that will be implanted or have prolonged contact with the body may require additional testing, such as hemocompatibility or genotoxicity tests.

• Sterility Testing: For sterile devices, manufacturers must demonstrate that the device is sterilized properly and remains sterile during use. Sterility assurance level (SAL) testing is required.

• Packaging Safety: Packaging must ensure that the device is protected during transportation and storage. It must also maintain the sterility of sterile devices and must be able to withstand environmental conditions (e.g., temperature, humidity) without compromising the safety of the device.

5. Post-Market Surveillance and Adverse Event Reporting

Once a device is approved and marketed in China, manufacturers are required to have systems in place for post-market surveillance to monitor the device’s safety during its use. Key requirements include:

• Adverse event reporting: Manufacturers must report any serious adverse events (e.g., injuries, malfunctions) associated with their devices to the NMPA. The report should include detailed information about the event, the device involved, and any corrective actions taken.

• Post-market studies: Manufacturers may be required to conduct post-market studies or surveillance to gather real-world data on the device’s safety and effectiveness.

• Product recalls: If safety issues are discovered post-market, the manufacturer may be required to initiate a recall or corrective action plan to mitigate risks.

6. Labeling and Instructions for Use (IFU)

The safety of the device must be clearly communicated through labeling and the instructions for use (IFU). The labeling should include important safety information, such as:

• Warnings and contraindications: Clear instructions on how to use the device safely, including any contraindications or conditions where the device should not be used.
• Maintenance and disposal instructions: Guidance on proper maintenance and safe disposal of the device after use.
• Emergency procedures: Steps to follow in case of malfunction or adverse event.
• Hazard symbols: Standardized symbols to represent safety warnings, e.g., electrical hazards, non-sterile conditions, or temperature limits.

The instructions for use must be in Chinese, and clearly state the intended use, operational instructions, and any risks associated with misuse.

7. Quality Management System (QMS)

Manufacturers must demonstrate that they maintain a robust Quality Management System (QMS). Compliance with ISO 13485 is required to ensure that manufacturing processes, quality control, and documentation practices are in place to guarantee the safety and effectiveness of medical devices.

• Manufacturing facilities must be regularly audited to ensure compliance with GMP (Good Manufacturing Practice).
• Quality assurance must extend to all stages of the product lifecycle, from design and manufacturing to distribution and post-market activities.

Conclusion

The safety requirements for NMPA certification of medical devices in China are comprehensive and rigorous. They involve compliance with Chinese national standards (GB standards), implementation of risk management processes (ISO 14971), clinical evaluations (for high-risk devices), and various safety tests (electrical, mechanical, and biological). In addition, post-market surveillance, effective labeling, and a solid QMS are necessary to ensure ongoing safety and efficacy. By meeting these requirements, manufacturers can ensure that their devices will be safe for use in China’s market.