Clinical Evaluation Reports or Clinical Trials?

Grace Fu Palma, founder and CEO of Boston-based China Med Device, LLC, a firm specializing in commercialization and funding for medtech companies entering China, explains how medtech companies can save time and expense for medical device registrations in China.

China’s new requirements for CERs (Clinical Evaluation Reports) and CTs (Clinical Trials) have now been in place for more than two years. Understanding the difference and their appropriate use can save manufacturers significant cost and time to market.

The Regulations for the Supervision and Administration of Medical Devices (State Council Decree No. 650), implemented June 1, 2014, led to a wave of new CFDA regulations, including 100 decrees and guidelines on registration alone.

The new requirements for clinical evaluations or clinical trials have significant implications for any manufacturer’s medical device registration costs, approval or rejection.

For a new device registration, the manufacturer must first determine the device classification within the CFDA classification catalogue. U.S. FDA classification does NOT correspond to that of CFDA. A U.S. FDA exempt device could be a class II in China.

Generally, a class I device needs to file with CFDA only. Most class III devices need a clinical trial, especially if the devices are listed in the “Catalogue for Class III Medical Device that Needs Clinical Trial.”

After you know the classification of your device in the CFDA classification system, check first to see if you device is on the clinical trial exempt list. Make sure that you refer to the new updated clinical trial exempt list: 1) CFDA Notice No. [2016] No. 133 Clinical Trial Exemption List for Class II Medical Devices, released on 2016.09.27, 2) CFDA Notice No. [2016] No. 133 Clinical Trial Exemption List for Class III Medical Devices released on 2016.09.27.

If a device is not listed on the clinical trial exempt list in class II or certain types of class III, the manufacturer should determine the option of CER or CT and consult the subject expert in China.

Most companies should choose CER instead of CT for several reasons. Most importantly, CT takes more than 12 to 18 months and costs more than $500,000, while CER typically takes 3 to 4 months and costs $40,000 to $100,000.

CERs must comply with CFDA Medical Device Clinical Evaluation Technical Standards. For low risk, matured devices where there is an established manufacturing process and a large amount of available safety and clinical effective data, a CER is a viable option.

Clinical evaluation data typically consist of 1) Clinical Literature — Data from other devices, 2) Empirical Data — Clinical Data done outside China, 3) Clinical Trial — Clinical Data done inside China.

The key questions for an effective CER is the following:

• Is there any predictive device in China?
• Do you have sufficient technical and clinical information for the predictive device?
• Have you done clinical trials outside China?
• Are the clinical trial data sufficient in terms of sample size, indication, coverage, Asian/Chinese data subgroup?

CFDA judges whether or not the CER is sufficient. It is very important that you have a subject expert to evaluate and write the CER. — Grace Fu Palma | gpalma@chinameddevice.com (978) 390-4453 www.chinameddevice.com