Clinical Evaluation Report (CER) for Medical Devices in China – Areas to Look Out For

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Clinical Evaluation Report (CER) for Medical Devices in China – Areas to Look Out For

Clinical Evaluation Report

Clinical Evaluation Report

In this article we will provide an update on Clinical Evaluation Report (CER) requirements in China by NMPA (CFDA). Furthermore, you will learn about areas that you must pay special attention to when preparing a CER for China’s NMPA (CFDA).

Clinical Evaluation Report (CER) – What Is It?

To begin with, as the name indicates, a  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:

(1) CER for clinical exemption, and

(2) Full CER for clinical unexempt.

Requirements in China

You should be able to prove to NMPA (CFDA) through your CER, with credible data that

(1) your medical device meets its design goal, and

(2) your device won’t cause adversary effects on patients.

Currently, Clinical Evaluation Reports are required for Class II and III medical devices.

All class II and III medical devices require a CER. NMPA (CFDA) has published a list of exempted devices. You will only need to submit a simplified CER if your device is on the list. For all other Class II and III devices, a full China CER will be required. NMPA (CFDA) may also require specific technical information in CERs for certain products.

According to NMPA (CFDA), your CER must summarize credible clinical data. Such data may include, clinical literature, experience and trials, etc.  In some cases, there are already significantly equivalent products approved in China. Consequently, you must bear the burden to document a thorough comparative study in your clinical evaluation report.  To clarify, this is different from CER requirements in other major markets worldwide.

Predicate Product Definition

When choosing an equivalent for your China CER, the first requirement is that it must be approved by NMPA (CFDA) in China. Additionally, the equivalent must be within its validity period (all devices in China must be renewed every 5 years in order not to lose their validity). Equivalency  between predicate and your product must be shown in terms of the following;

Clinical Evaluation Report (CER) Predicate/Equivalent Product Definition

 

 

 

 

 

 

 

 

NMPA can accept the differences between the predicate and your product if there is no affect on safety & effectiveness.

A manufacturer may not have its own predicate device approved by NMPA (CFDA) to show equivalency. In this case, the manufacturer must obtain authorization from a third-party manufacturer with a similar device.

Clinical Evaluation Report – 16 Items to Cover

Clinical Evaluation Report 16 Items to Cover

 

 

 

 

 

 

 

 

Difference Analysis

In your CER for the NMPA (CFDA), you will also need to show that if the differences between the product and its predicate affect safety and effectiveness.

Data for this analysis may include;

  • Non-clinical research data (such as testing report, animal testing etc.)
  • Clinical literature
  • Observed data (adverse event, recalls, complaints)
  • Research on Chinese population
  • Clinical trial

Work with a Partner

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.

About China Med Device, LLC

ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.