Fast-Track Approval Updates in October & November 2020

During the past month, the NMPA (National Medical Device Evaluation) and CMDE (Center for Medical Device Evaluation) were actively involved in facilitating the fast-track approvals for medical devices in the Chinese market.

Procedure for Prioritized Review and Approval of Medical Devices

On October 29, the CMDE announced (No.22 – 2020) an additional set of specifications for medical devices applying for fast-track approval via the Procedure for Prioritized Review and Approval of Medical Devices.

The specifications are listed in the following:

• The product is urgently needed for clinical use and there are no similar devices existing in the market yet.
• The product is expected to diagnose and treat serious life-threatening diseases
• There is currently no effective way to diagnose or treat the disease in China
• The principle of operating the device is clear and finalized with a basic theoretical and experimental approach
• There is sufficient clinical trial data to perform a valid assessment and to prove the product’s ability or provide clinical value

The announcement also addressed some additional information required in the basic dossier submission:

• Clinical evaluation of the product’s condition and setting while operating
• The clinical value of the product with data information to support
• Evidence to show that only this product in the market has the capability to diagnose or treat the disease effectively
• Applicants should refer to the Guidelines for Conditional Approval for Marketing of Medical Devices for dossier submission

Emergency Approval Procedure for Medical Devices

On November 5, the NMPA announced that 2 COVID-19 detection reagent products have been registered in China via the Emergency Approval Procedure for Medical Devices. According to the announcement, a total of 51 products had been registered via the procedure in 2020:

• 24 new coronavirus nucleic acid detection reagents
• 25 antibody detection reagents
• 2 antigen detection reagents

Special Review Procedure for Innovative Medical Devices

On November 2, the CMDE announced that 7 domestic products and 1 overseas product (Medtronic, Inc) had been approved to apply for the Special Review Procedure for Innovative Medical Devices.

On November 11, the NMPA announced that 3 domestic products had been registered via the Special Review Procedure for Innovative Medical Devices:

• Home test kits for colon cancer (New Horizon Health Ltd.)
• CT diagnostic software (Yukun (Beijing) Network Technology Co., Ltd.)
• Drug Eluting Balloon PTA Catheter (Zylox Medical Device Co.)

By Jacky Li. Contact Cisema if you would like to learn more.