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  • Fast-Track Approval Updates in October & November 2020

Fast-Track Approval Updates in October & November 2020

Tuesday, 24 November 2020 / Published in Medical Device, News, NMPA Registration in China

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.

Tagged under: Emergency Approval Procedure, fast-track approval, innovative medical device, NMPA Green Channel, Prioritized Review, Special Review Procedure

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