Clinical Evaluation Report (CER) is a file that you prepare in order to document data and results of the clinical evaluation of your medical device. There are two types of CERs in China:
- CER for clinical exemption, and
- Full CER for clinical unexempt.
You should be able to prove to NMPA (CFDA) through your CER, with credible data that
- Your medical device meets its design goal, and
- Your device won’t cause adversary effects on patients.
Currently, Clinical Evaluation Reports are required for Class II and III medical devices.
CER for Clinical Exemption:
On September 30, 2018, NMPA (CFDA) have implemented the latest Clinical Exemption Catalogue for Medical Device and IVD, which included:
- 66 Class II medical devices
- 19 Class III medical devices
- 246 Class II IVD
- 31 Class III IVD (the first time to issue clinical exempt class III IVD)
Once your medical device is on the Clinical Exemption Catalogue, you only need to have a simple clinical evaluation report to meet China product registration need. For exempt IVD product, mass comparison study needed to be conducted in China. Registrant need to do a methodological comparison study between the IVD and predicate product that has been approved in China to prove that the IVD are substantially equivalent with the predicate product.
Full CER for Clinical Unexempted:
For clinical unexempted medical device, there is the option to bypass the clinical trial by writing a clinical evaluation report (CER). The CER requires the manufacturer to compare its product with a predicate product that has been already approved by NMPA. China Med Device will help you evaluate the technical and clinical information from the predicate device, search English and Chinese clinical database for literature as well as prepare and finalize the CER.
How to Determine CER pathway:
CER 16 Things to Cover
- Basic Principles
- Production technology
- Manufacturing materials
- Safety evaluation
- National and industrial standards
- Intended Use
- Using methods
- Precautions & Warning
- Delivery conditions (passive device)
- Sterilization & Disinfection methods
- Instruction for Use
The CER requirements in China present overseas medical device manufacturers with challenges. However, knowing what’s required will help move the process forward more smoothly. We recommend you look out for a partner who can help you move through the Clinical Evaluation Reports (CERs) and Clinical Trials (CTs) process in China more quickly. Understanding the difference between CERs and CTs can save cost and time getting into the China market. China Med Device is a qualified contract research organization (CRO) and has strong expertise in China clinical compliance. This can help you determine your clinical pathway, write your CER and complete local clinical trials.