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.

Implement 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.

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.

Compile technical documentation, including device specifications, design drawings, and manufacturing process details.

Obtaining ethical approval for conducting clinical studies as part of the process for NMPA (National Medical Products Administration) registration of multi-parameter monitors involves following established ethical guidelines and obtaining clearance from an accredited ethics committee or institutional review board (IRB).

Review NMPA Guidelines: Familiarize yourself with specific requirements and expectations outlined in NMPA regulations and guidance documents for medical device registration.