Freelance Medical Writer, writing clinical evaluation documents for medical devices that secure compliance with regulatory requirements
✳ Today, I would like to explore the key components of creating a robust Clinical Evaluation Report (CER) for submission to the NMPA! ✳ The content of the CER should include the following elements: 1️⃣ Product description and R&D background: This section includes the basic information, scope, and R&D background of your medical device, as well as the working principle, existing diagnostic or therapeutic methods and clinical applications. The relationship of the device to existing diagnostic or therapeutic methods, clinical efficacy and intended clinical benefits should also be addressed. 2️⃣ Scope of the clinical evaluation: This section describes the scope of the clinical evaluation. 3️⃣ Clinical evaluation approach: Explain your clinical evaluation approach (see one of my previous posts for more information). 4️⃣ Analysis and evaluation with the clinical data of medical devices of the same type: This section should provide a basic description, demonstration of equivalence, and summary, evaluation, and analysis of the clinical data of the equivalent device. See my previous post for more information. 5️⃣ Conclusion: Summarize the results and demonstrate the safety and performance of your medical device. 6️⃣ Clinical evaluators: The expertise and roles of the evaluators involved. 7️⃣ Other issues to be addressed (if applicable): Address any other relevant issues. ❗ What is your CER’s goal? To demonstrate the safety and intended performance of your medical device.❗ Keep this in mind while preparing the CER. With a well-structured clinical evaluation report that meets NMPA requirements, you will pave the way for successful market entry in China. ❓ What challenges have you faced in preparing a Clinical Evaluation Report for NMPA submission ❓ ------------------------------------------------------------------------------------- If you are looking for a freelance Medical Writer, writing clinical evaluation documents for medical devices that secure compliance with regulatory requirements, please contact me 📨 . #MedicalDevices #RegulatoryCompliance #NMPA #ClinicalEvaluationReport #ClinicalEvaluation #RegulatoryWrititng #MedicalWriting
