Clinical Evaluation Reports (CER) play a crucial role in the registration of medical products in China. Manufacturers must meet China’s NMPA requirements for clinical evaluation reports to obtain regulatory approval to market their products. A CER report will be used when a device is exempt from doing a clinical study in China. In this blog post, we’ll discuss CERs, China’s NMPA requirements for these reports, and how medical device manufacturers can meet these requirements to achieve successful NMPA registration.
Clinical Evaluation Reports
A clinical evaluation report is a systematic analysis of clinical data related to a medical device. The objective of a CER is to demonstrate the safety and effectiveness of the device and to provide assurance of its clinical performance. They are typically required for Chinese medical device product registration.
A CER is submitted during the registration of a new medical device. It’s a comprehensive report that provides an assessment of the safety and efficacy of the device based on existing clinical data. It typically includes a detailed description of the device, its intended use, and indications, a comprehensive literature review of relevant clinical data, a summary of clinical data, a risk analysis that identifies potential risks associated with the device and outlines mitigation strategies, and a conclusion that provides an assessment of the clinical safety and efficacy of the device.
Elements of a Clinical Evaluation Report
It typically includes the following elements:
- Device Description and Intended Use – Detailed description of the medical device and its intended use.
- Clinical Literature Review – A comprehensive review of relevant clinical data sources, including published studies and clinical trials.
- Clinical Data Summary – Summary of clinical data, including the results of clinical trials and adverse events and comparison between the medical device to be registered and equivalent devices in China.
- Risk Analysis – Risk analysis that identifies potential risks associated with the device and outlines mitigation strategies.
- Conclusion And Recommendations – A conclusion that provides an assessment of the clinical safety and efficacy of the device and recommendations for its use.
- References – List of all relevant clinical data sources used in the CER.
China’s NMPA Requirements for Clinical Evaluation Reports
Medical device manufacturers must obtain NMPA registration before their products can be marketed in China. The registration process includes the submission of a CER if the device is exempt from a China clinical study.
China’s NMPA Requirements for CERs
NMPA requirements in China for CERs include:
- A detailed description of the medical device, including its intended use and indications.
- A comprehensive literature review of relevant clinical data, including published studies and clinical trials.
- A summary of clinical data, including the results of clinical trials and adverse events and comparison between the medical device to be registered and equivalent devices in China.
- A risk analysis that identifies potential risks associated with the device and outlines mitigation strategies.
- A conclusion that provides an assessment of the clinical safety and efficacy of the device.
- References to all relevant clinical data sources.
It’s important to note that its requirements may differ from those of other regulatory bodies, such as the FDA or the European Medicines Agency. Medical device manufacturers must understand these differences and ensure that their CERs meet the specific requirements of the NMPA.
How to Meet China’s NMPA Requirements for Clinical Evaluation Reports
To meet China’s NMPA requirements for CERs, medical device manufacturers should follow a comprehensive process that includes planning, data selection, literature review, risk analysis, competitive analysis, report writing, and submission.
Planning For the Clinical Evaluation Process
Before starting the process, manufacturers should develop a plan that outlines the scope of the evaluation, identifies potential data sources, and establishes timelines for completion. It’s also important to identify the required deliverables and any additional requirements that may be imposed by the NMPA.
Selecting Appropriate Clinical Data
Manufacturers must identify and select appropriate clinical data sources, including published literature, clinical trials, and adverse event reports. The data should be relevant to the device being evaluated and of sufficient quality to support the conclusions drawn in the CER.
Conducting a Comprehensive Literature Review
A comprehensive literature review is essential to ensure that all relevant clinical data are included in the CER. Manufacturers need to use a systematic and transparent approach to search and select literature sources, and they should critically appraise the quality and relevance of the studies they include.
Identifying and Mitigating Potential Risks
They should conduct a risk analysis to identify potential risks associated with the device and outline strategies to mitigate these risks. The risk analysis should be based on a thorough understanding of the device and its intended use, as well as the clinical data collected.
Writing the Clinical Evaluation Report
The report must be written in a clear and concise manner, with a logical structure that reflects the objectives and requirements of the NMPA. It should include all required elements, and the conclusions and recommendations should be supported by the clinical data presented.
Preparing the Submission Package
It’s crucial for manufacturers to assemble a complete and accurate submission package that contains the CER and all other essential documents such as device labeling and manufacturing information, ensuring that it fully complies with NMPA requirements.
Responding to Feedback from the NMPA
In case the NMPA provides feedback or requests clarification on the CER, manufacturers must respond promptly to all requests and provide the necessary information to address any concerns raised by the regulatory body.
Meeting China’s requirements for clinical evaluation reports is a critical step in obtaining NMPA product registration in China for medical devices. Manufacturers must understand the specific requirements of the NMPA, follow a comprehensive process, and address common challenges to ensure successful registration. By following these best practices, manufacturers can navigate the regulatory landscape in China and bring their products to market successfully.