For NMPA (National Medical Products Administration) registration certification in China, medical devices must adhere to a set of comprehensive standards and regulations. These standards ensure that devices are safe, effective, and compliant with Chinese regulations. Here’s an overview of the key standards and requirements:

1. Chinese National Standards (GB Standards)

Overview:

• Standards: GB standards (Guobiao standards) are mandatory national standards that medical devices must meet. They cover various aspects of device performance, safety, and quality.
• Application: Devices must comply with specific GB standards relevant to their type and classification. These standards can include general safety requirements as well as specific performance criteria.

Examples:

• GB 9706.1: General requirements for the safety of medical electrical equipment.
• GB 191: Packaging for transport of goods.
• GB 14233: Sterilization of medical devices and related procedures.

2. International Standards

Overview:

• Standards: International standards recognized by NMPA can be used to demonstrate compliance. These include ISO (International Organization for Standardization) and IEC (International Electrotechnical Commission) standards.
• Application: Devices that meet recognized international standards may streamline the registration process, provided that the standards are aligned with Chinese regulations.

Examples:

• ISO 13485: Quality management systems for medical devices.
• ISO 10993: Biological evaluation of medical devices.
• IEC 60601: Safety and performance of medical electrical equipment.

3. Technical Specifications and Guidelines

Overview:

• Specifications: NMPA may have specific technical specifications or guidelines that apply to certain types of devices. These are detailed instructions that align with national regulations.
• Application: Manufacturers must adhere to these specifications when designing and manufacturing their devices.

Examples:

• Guidelines for Clinical Evaluation: Requirements for clinical data to support device efficacy and safety.
• Guidelines for Quality Management System Documentation: Specific documentation practices required by NMPA.

4. Good Manufacturing Practice (GMP)

Overview:

• Standards: Manufacturers must comply with Good Manufacturing Practice (GMP) as defined by NMPA.
• Application: GMP ensures that medical devices are consistently produced and controlled according to quality standards. Compliance with GMP is essential for NMPA certification.

Examples:

• NMPA GMP Requirements: Specific requirements for the manufacturing processes, quality control, and documentation practices.

5. Clinical Trial Requirements

Overview:

• Standards: For certain devices, particularly those classified as Class II or III, clinical trials may be required to demonstrate safety and effectiveness.
• Application: Clinical trials must comply with NMPA guidelines and Good Clinical Practice (GCP) standards.

Examples:

• Clinical Trial Guidelines: Requirements for the design, conduct, and reporting of clinical trials.

6. Labeling and Packaging Standards

Overview:

• Standards: Devices must meet specific labeling and packaging requirements as outlined by NMPA.
• Application: Labels must include required information in Chinese and comply with NMPA guidelines regarding content and format.

Examples:

• Labeling Requirements: Information on device usage, manufacturer details, and safety warnings.
• Packaging Requirements: Packaging must ensure product safety during transportation and storage.

7. Post-Market Surveillance Requirements

Overview:

• Standards: Post-market surveillance requirements ensure that devices continue to meet safety and performance standards once they are on the market.
• Application: Manufacturers must implement systems for monitoring device performance, reporting adverse events, and addressing issues that arise.

Examples:

• Adverse Event Reporting: Procedures for reporting and managing adverse events associated with the device.

Additional Considerations

• Updates and Amendments: Standards and guidelines are subject to updates and changes. Manufacturers should regularly check for the latest requirements and incorporate them into their compliance strategies.
• Local Expertise: Engaging with local regulatory experts or consultants can help navigate the complexities of NMPA standards and ensure compliance.

In summary, NMPA registration certification in China requires compliance with a range of standards, including Chinese National Standards (GB), international standards, technical specifications, GMP, clinical trial requirements, and labeling and packaging standards. Adhering to these standards is essential for obtaining certification and ensuring that medical devices are safe and effective for the Chinese market.

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