Clinical Evaluation Report (CER) Requirements for Medical Devices in China
When registering a medical device in China, the Clinical Evaluation Report (CER) is one of the most important parts of your submission to the National Medical Products Administration (NMPA).It proves that your device is safe, effective, and performs as intended for its target patient population. If your CER is incomplete or non-compliant, it can lead to costly delays or outright rejection.In this guide, we’ll cover everything you need to know about CER requirements in China — and how OMC Med...
