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 Medical can help you prepare a winning submission.
Clinical Evaluation Report China
To understand its role in the registration process, let’s first look at what a Clinical Evaluation Report means under NMPA rules.
What is a Clinical Evaluation Report (CER) Under NMPA Rules?
A Clinical Evaluation Report is a structured document summarizing clinical data that demonstrates your medical device’s safety and performance.
Under China’s Medical Device Regulations (Order No. 739), the CER is a mandatory part of the registration dossier for:
- Class II and Class III devices
- Some Class I devices depending on their risk profile
A CER may include:
- Clinical trial data (local or overseas)
- Literature review of equivalent devices
- Post-market surveillance (PMS) data from other markets
- Comparison with predicate devices
When Do You Need a CER in China?
The NMPA requires a CER in these situations:
- Registering Class II or III devices (imported or domestic)
- Renewal applications for existing registrations
- Major changes in design, intended use, or manufacturing
- New devices with no registered predicate in China
- Clinical trial exemption requests
💡 Tip: Some low-risk devices may qualify for clinical data exemption — but you still need evidence to prove eligibility.
Key Components of a CER in China
A compliant CER should follow NMPA guidance documents and YY/T 0287 standards.
Typical CER sections include:
- Device Description & Intended Use – Clear technical description, patient population, and clinical benefits.
- Risk Analysis – Hazard identification, mitigation measures, and benefit–risk evaluation.
- Clinical Data Sources – Literature, clinical trials, PMS reports, or registry data.
- Data Appraisal & Analysis – Evaluating the relevance and quality of the data for the Chinese market.
- Conclusion – Justification that the device meets safety and effectiveness requirements.
Local Testing, Data Localization, and Translation Needs
- Local Type Testing – For most devices, the NMPA requires testing in China-approved laboratories before CER acceptance.
- Data Localization – Clinical data involving Chinese patient populations is strongly preferred.
- Translation – All technical documents must be in simplified Chinese, with accuracy in technical terms to avoid rejection.
Challenges Manufacturers Face in CER Preparation
- Mismatch between foreign and Chinese standards
- Lack of sufficient clinical equivalence data
- Incomplete risk analysis that fails to meet NMPA expectations
- Delays caused by type testing bottlenecks
- Translation errors affecting technical meaning
How OMC Medical Supports CER Preparation and Registration
Preparing a CER for China can be complex — but OMC Medical makes the process simpler and faster.
Our services include:
- Gap Analysis – Reviewing your existing clinical data against NMPA requirements
- Equivalence Assessment – Comparing your device with predicate devices registered in China
- Testing Coordination – Arranging type testing in NMPA-approved labs
- Technical Translation – Ensuring accurate, regulator-ready Chinese translations
- Regulatory Liaison – Communicating directly with NMPA reviewers to resolve queries
We’ve helped manufacturers worldwide get their medical devices approved in China with fewer delays and higher success rates.
📞 Contact OMC Medical today for expert assistance in preparing your Clinical Evaluation Report and navigating the NMPA registration process.
Frequently Asked Questions (FAQs)
Q1: Is a CER mandatory for Class II devices in China?
Yes, Class II and Class III devices generally require a CER as part of the registration dossier.
Q2: Can foreign clinical data be used for a CER in China?
Yes, but preference is given to data involving Chinese patients. Equivalence must be justified.
Q3: How long does it take to prepare a CER for NMPA submission?
It can take several weeks to months, depending on data availability and testing requirements.
