For NMPA-registered medical devices in China, international authorization requirements include:

1. Authorized Representative: Manufacturers outside China must appoint a local Authorized Representative who will act as the liaison between the manufacturer and the NMPA.

2. Quality Management System (QMS): The device must comply with international standards such as ISO 13485, which is recognized by the NMPA.

3. International Certificates: If available, provide certificates from other regulatory bodies (e.g., CE, FDA) to support the safety and efficacy of the device.

4. Clinical Data: Depending on the device, clinical data from international studies may be required to demonstrate safety and effectiveness.

5. Technical Documentation: Ensure all technical documentation meets NMPA requirements, including risk assessments and product specifications.

6. Labeling and Instructions: All product labeling and instructions must be in compliance with Chinese regulations and translated into Chinese.

These requirements help ensure that the medical device meets Chinese regulatory standards and is recognized as safe and effective in the Chinese market.