Obtaining NMPA (National Medical Products Administration) certification for medical devices in China involves navigating a complex regulatory framework. Here’s an overview of the applicable rules and conditions:

1. Regulatory Framework

• Medical Device Classification: The NMPA categorizes medical devices into three classes based on risk:
  • Class I: Low-risk devices that require simple filing.
  • Class II: Moderate-risk devices requiring more extensive documentation and some level of regulatory oversight.
  • Class III: High-risk devices necessitating rigorous review, including potential clinical trials and comprehensive documentation.

2. Applicable Standards

• GB Standards: Devices must comply with relevant GB (Guo Biao) national standards that specify safety and performance requirements. Key GB standards may include:
  • GB 9706 (general medical electrical equipment standards).
  • GB 15810 (biocompatibility testing).
• ISO Standards: Compliance with international standards such as ISO 13485 (quality management systems) and ISO 14971 (risk management) is also essential.

3. Documentation Requirements

• A comprehensive technical dossier is required, including:
  • Product descriptions and specifications.
  • Manufacturing processes and quality control measures.
  • Risk management and clinical evaluation reports (for Class II and III devices).
  • Labeling and instructions for use, translated into Mandarin.

4. Testing and Clinical Evaluation

• Pre-Clinical Testing: All devices must undergo relevant testing to demonstrate compliance with applicable safety and performance standards.
• Clinical Trials: Required for Class II and III devices, depending on existing data and the novelty of the device. Trials must adhere to Chinese Good Clinical Practice (GCP) guidelines.

5. On-Site Inspection

• For Class II and III devices, an on-site inspection of the manufacturing facility by NMPA officials or designated third parties may be required to assess compliance with quality management and manufacturing processes.

6. Legal Representation

• Foreign manufacturers must appoint a local legal representative to facilitate communication with the NMPA and manage compliance with post-market obligations.

7. Post-Market Surveillance

• Manufacturers are required to establish a post-market surveillance plan that includes monitoring for adverse events, reporting incidents to the NMPA, and conducting periodic safety reviews.

8. Fees and Timelines

• Application fees vary by device classification. The timeline for obtaining certification can range from a few months (Class I) to over a year (Class II and III), especially if clinical trials are involved.

9. Updates and Compliance

• The NMPA periodically updates its regulations and guidelines, so manufacturers must stay informed of any changes that may affect their products.

Conclusion

Successfully navigating the NMPA certification process requires a thorough understanding of the applicable rules, documentation, and testing requirements. Engaging with regulatory experts familiar with the Chinese medical device landscape can significantly improve the chances of a smooth certification process.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn