Yes, for NMPA (National Medical Products Administration) certification in China, you must comply with specific Chinese standards and regulations. Here’s an overview of the key standards you need to consider:

1. Chinese National Standards (GB Standards)

General Requirements: Medical devices must meet the relevant Chinese National Standards (GB standards), which cover safety, performance, and quality requirements. These standards are often aligned with international standards but may have specific requirements tailored to the Chinese market.

Device-Specific Standards: Each medical device type has its own set of GB standards. For example, standards exist for various categories such as diagnostic devices, therapeutic devices, and implantable devices.

2. Chinese Pharmacopoeia

Pharmacopoeia Standards: For devices related to pharmaceuticals or those involving drug delivery, compliance with the Chinese Pharmacopoeia is required. This includes standards for the quality and safety of pharmaceutical substances and preparations.

3. Regulatory Guidelines and Technical Requirements

Technical Guidelines: The NMPA issues technical guidelines that provide detailed requirements for specific types of medical devices. These guidelines cover aspects like clinical evaluation, risk management, and labeling.

Product-Specific Regulations: In addition to GB standards, there may be other regulations or technical requirements specific to certain types of devices, such as in-vitro diagnostics or high-risk medical devices.

4. Quality Management System

Good Manufacturing Practices (GMP): Compliance with Chinese Good Manufacturing Practices is required. The NMPA may inspect manufacturing facilities to ensure they adhere to these practices.

ISO Certification: While not a Chinese standard per se, having ISO 13485 (Medical Device Quality Management Systems) certification can support compliance with Chinese requirements, as it aligns with international best practices.

5. Labeling and Documentation

Chinese Labeling Requirements: All product labeling and instructions must be in Chinese and comply with NMPA regulations. This includes product names, indications for use, warnings, and user instructions.

Documentation Compliance: Ensure all technical documentation, including clinical data and product specifications, meets the specific requirements set forth by the NMPA and corresponding Chinese standards.

6. Clinical Trials and Data

Clinical Data Requirements: For many devices, especially those categorized as high-risk, clinical trial data must be provided to demonstrate safety and efficacy according to Chinese standards.

Local Trials: In some cases, the NMPA may require clinical trials to be conducted within China to meet local regulatory expectations.

Conclusion

Compliance with specific Chinese standards is essential for obtaining NMPA certification and entering the Chinese market. Adhering to GB standards, Chinese Pharmacopoeia, and other regulatory guidelines ensures that medical devices meet the necessary safety and performance criteria. It’s crucial to stay informed about the relevant standards and requirements for your particular device type to ensure a smooth certification process.

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