For NMPA certification of medical devices in China, adhere to the following standards and certificate requirements:
GB Standards: Devices must comply with relevant Chinese National Standards (GB) or international standards that have been adopted by China.
ISO 13485: Certification to ISO 13485 (Quality Management Systems for Medical Devices) is generally required to demonstrate adherence to quality management practices.
Technical Documentation: Provide detailed technical documentation that includes design, development, testing, and clinical data.
Clinical Trials: Depending on the device class, clinical trial data may be required to support safety and efficacy claims.
Risk Management: Document risk management processes following ISO 14971 (Application of Risk Management to Medical Devices).
Labeling Requirements: Labels and instructions must be in Chinese and comply with NMPA requirements, including specific information and warnings.
Product Testing: Devices must undergo testing in accordance with applicable standards. Results should be provided from recognized laboratories.
Certificates: Submit copies of any relevant certificates from other countries, which may aid in the evaluation but do not replace local requirements.
Ensure that all documents are accurate, complete, and translated into Chinese as required.