Yes, there are specific labeling and packaging requirements for medical devices in China as per NMPA regulations. Some key requirements include:
1. Labeling Language: The labeling of medical devices in China should be in Chinese. If the device is intended for export only, labeling in English or another language may be accepted, but Chinese labeling is still recommended.
2. Labeling Content: The labeling should include information such as the device name, specifications, model number, manufacturer's name and address, registration number, instructions for use, warnings, precautions, and storage conditions.
3. Symbols: The use of standardized symbols for indicating important information (e.g., "Do not reuse," "Use by date") is recommended. These symbols should comply with relevant Chinese standards.
4. Packaging: The packaging of medical devices should be designed to protect the device during storage and transportation. It should also include necessary information such as the device name, specifications, and manufacturer's information.
5. Sterile Devices: For sterile medical devices, the packaging should maintain the sterility of the device until the point of use. It should also include information on the sterility maintenance method and expiration date.
6. Compliance Marking: Medical devices that have successfully completed the registration process and obtained a registration certificate should bear the NMPA registration mark.
These are general requirements, and specific details may vary depending on the classification and intended use of the medical device. It's important to consult the NMPA regulations and seek guidance from regulatory experts to ensure compliance with labeling and packaging requirements for medical devices in China.
