Obtaining ethical approval for NMPA registration (National Medical Products Administration) of invasive blood pressure monitoring devices in China involves navigating a process that ensures the protection of participants' rights, safety, and well-being during clinical studies. Here’s a structured approach on how to obtain ethical approval:

1. Identify the Ethics Committee

1. Select an Independent Ethics Committee (IEC):

   • Identify and engage with an accredited Institutional Review Board (IRB) or Ethics Review Board (ERB) that is authorized to review and approve clinical research protocols in China.

2. Local Requirements:

   • Understand the specific requirements and procedures of the chosen ethics committee, including their review processes, submission guidelines, and documentation requirements.

2. Prepare the Study Protocol and Documentation

1. Develop the Study Protocol:

   • Create a comprehensive study protocol that details the objectives, design, methodology, participant selection criteria, data collection procedures, and statistical analysis plan.
   • Ensure that the study protocol aligns with NMPA regulatory requirements and guidelines for clinical studies.

2. Informed Consent Form:

   • Draft an informed consent form (ICF) that provides clear and understandable information to participants about the study purpose, procedures, potential risks and benefits, confidentiality measures, and their right to withdraw from the study at any time.

3. Other Required Documents:

   • Prepare additional documents such as investigator brochures, participant information sheets, safety monitoring plans, and any relevant background information on the device.

3. Submit to the Ethics Committee

1. Compile the Submission Package:

   • Compile all required documents into a submission package according to the ethics committee’s guidelines. Ensure that the documents are organized, complete, and formatted as per the committee’s requirements.

2. Submission Process:

   • Submit the ethics committee application package to the designated contact person or office of the chosen IRB/ERB. Follow their specified submission procedures, which may include electronic submission, multiple hard copies, or online portals.

4. Ethics Committee Review

1. Review Timeline:

   • Await the ethics committee’s review and evaluation of the submitted study protocol and documents. The review timeline can vary depending on the committee’s workload and meeting schedules.

2. Respond to Queries:

   • Be prepared to address any queries or requests for clarifications from the ethics committee promptly. Provide additional information or revisions to the study protocol as requested.

5. Approval and Compliance

1. Ethical Approval:
   • Once approved, the ethics committee will issue an ethical approval certificate or letter indicating that the study protocol complies with ethical standards and regulatory requirements.
2. Compliance Requirements:
   • Adhere to the conditions and requirements outlined in the ethical approval, including ongoing reporting of adverse events, safety monitoring, and any modifications to the study protocol.

6. Document Retention and Reporting

1. Document Retention:
   • Maintain thorough documentation of all correspondence, submissions, approvals, and amendments related to the ethical review process.
2. Reporting Obligations:
   • Report any significant deviations from the approved study protocol or unexpected adverse events to the ethics committee promptly.

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