China’s 3rd Batch of Exemptions From Clinical Trial Requirements

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, considers the China Food and Drug Administration’s moves to speed registrations and approvals of medical devices and IVDs.

CFDA will continue to add more medical devices and IVDs to its clinical trial exemption list this year to keep up with international standards and to further speed registrations and approvals.

In the U.S., the medical device and IVD approval process is mature and well-developed, and 80% of medical devices and IVDs can find referred predicate products and get exempted from a clinical trial. But in China, 50% of medical devices/IVDs require clinical trials to complete their registration.

To keep up with western countries, the CFDA decided to issue several updates of the Medical Device/IVD Clinical Trial Exemption List. On Oct. 31, the CFDA released its third batch of medical devices exempt from clinical trial requirements, including 37 Class II, 11 Class III and 116 Class II in vitro diagnostic devices.

For new device registrations in China, the manufacturer must first determine the device classification within the CFDA’s classification catalog. U.S. FDA classification does not correspond to that of CFDA. For example, an exempt device in the U.S. could be a Class II device in China.

Generally, a Class I device only needs to be filed with the CFDA. But most Class III devices require a clinical trial, especially if they are listed in the Catalog of Class III Medical Devices that Need Clinical Trials.

After you know the classification of your device in the CFDA’s system, check first to see if your device is on the clinical trial exempt list. Make sure you refer to the newly updated 3rd batch of the clinical trial exempt lists.

If your devices/IVDs are on a clinical trial exemption list, you only need to submit the following clinical evaluation materials:

• A comparison of your product information and the related content in the clinical trial exemption list; and
• A comparison of your product and approved predicate product(s).

This year will be a big year for healthcare reform in China. Based on the new policy from China’s 19th CPC National Congress aimed at building an efficient healthcare system, CFDA announced the new Opinions on Deepening the Review and Approval System Reform and Encouraging the Drug and Medical Device Innovation. This guidance document includes the State Council’s policies to reform the clinical trial system, such as accepting overseas clinical data and expanding regulatory resources for clinical trials. — Grace Fu Palma | gpalma@chinameddevice.com (978) 390-4453 www.chinameddevice.com