For NMPA (National Medical Products Administration) registration of Class III medical devices in China, several key standards and guidelines must be followed to ensure compliance and facilitate the registration process. Here are the primary standards and regulatory requirements relevant to Class III medical devices:

1. Medical Device Classification

• China Medical Device Classification Catalogue: Defines the classification of medical devices based on their risk level and intended use. Class III devices are considered high-risk devices that require the most stringent regulatory scrutiny.

2. Quality Management System (QMS)

• ISO 13485: International standard for quality management systems specific to the medical device industry. Certification to ISO 13485 demonstrates that the manufacturer has implemented a robust QMS that meets regulatory requirements.

3. Technical Documentation

• GB Standards: Relevant Chinese national standards may apply to various aspects of medical devices, including materials, testing methods, safety, and performance requirements.

• ISO Standards: International Organization for Standardization (ISO) standards applicable to medical devices, such as ISO 14971 for risk management and ISO 10993 for biocompatibility testing.

4. Clinical Evaluation and Performance Testing

• Clinical Data Requirements: Depending on the device type and classification, clinical evaluation reports and/or clinical trial data may be required to demonstrate device safety and efficacy.

• Testing Standards: Compliance with relevant testing standards such as electrical safety (e.g., IEC 60601 series), biocompatibility (ISO 10993 series), and performance testing specific to the device's intended use.

5. Labeling and Instructions for Use

• GB/T Standards: Chinese national standards for labeling requirements, including content and format specifications.

• Language Requirements: All labeling and instructions for use must be in Chinese to comply with local regulations.

6. Regulatory Requirements

• NMPA Regulations and Guidelines: Specific regulatory requirements outlined by the NMPA for Class III medical devices, including documentation, submission procedures, and post-market surveillance obligations.

• Guidance Documents: Additional guidance documents issued by the NMPA to clarify regulatory expectations and interpretations for compliance.

7. Additional Considerations

• Local Agent Requirements: Appointment of a local agent or representative in China who is registered with the NMPA to facilitate communication and regulatory submissions.

• Notarization and Translation: Certain documents may require notarization and all documentation must be translated into Chinese by qualified translators.

Contact Us：

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