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- 2024-07-26NMPA certification is mandatory for medical devices to be legally marketed and sold in China. Without certification, manufacturers cannot distribute or sell their devices in the Chinese market.
- The duration of the NMPA certification process for invasive blood pressure monitoring devices can vary based on several factors, including the complexity of the device, the completeness of the application, and the current workload of the NMPA.
- Determine the correct classification of your invasive blood pressure monitoring device according to Chinese regulations (e.g., Class II or III). This classification will dictate the regulatory pathway and requirements.
- Determine the classification of your invasive blood pressure monitoring device according to Chinese regulations. Classification is based on factors such as intended use, technology, and potential risks.
- What should be considered after obtaining NMPA certification for invasive blood pressure monitoring?2024-07-26Implement a robust post-market surveillance system to monitor the performance and safety of your device once it is on the market.
- Detailed description of the invasive blood pressure monitoring device, including its intended use, design features, and operational specifications.
- 2024-07-26Determine the classification of your invasive blood pressure monitoring device according to Chinese regulations. Classification is based on factors such as intended use, technology, and potential risks.
- Compile technical documentation, including device specifications, design drawings, and manufacturing process details.
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