NMPA: Four Imported Devices Go into Fast-Track Channel in February

NMPA granted nine manufacturers innovation approval and priority review status, including four overseas ones.

The List

Oncology

• Mevion Medical Systems: Proton Therapy System
• Biosense Webster (Israel): Magnetic Positioning Multi-channel Pulsed Electric Field Ablation System

Ophthalmic

• EyeYon Medical Ltd: Artificial Corneal Endothelial Membrane
• Weizhi Medical: Implantable Retinal Electrical Stimulator Implant
• Guangzhou Ruijia: Collar button artificial cornea

Cardiovascular

• XVIVO Perfusion AB: Lung perfusion system

Orthopedic

• Hangzhou Jianjia Robotics: Hip Replacement Surgery Navigation System

Radiology

• Foshan Ruijiatu: Mobile Head and Neck Magnetic Resonance Imaging System
• United Imaging: Magnetic resonance imaging system

How to Qualify the Fast-track Channel

Three fast-track channels have been established by NMPA to encourage innovation and deal with unmet medical needs: Innovation Approval, Priority Review, and Emergency Approval.

The “Innovation Approval Procedure for Medical Devices” lists four criteria for domestic or imported Class II / Class III medical devices manufacturers to apply:

1. Provide significant clinical application value,
2. Own valid invention patent and have China Patent & Trade Office coverage,
3. Complete the preliminary study on a prototype with traceable data, and
4. Have an authorized in-country legal entity.

For Priority Review, applicants need to meet one of the following scenarios:

1. Treat rare diseases with significant clinical application value,
2. Diagnose or treat malignant tumors with significant clinical application value,
3. Diagnose or treat geriatric diseases, with no effective diagnosis or treatment
4. Be intended for pediatric diseases with significant clinical application value,
5. Be intended for unmet medical needs, which currently have no effective diagnosis or treatment, or
6. Be listed in National Science and Technology Major Projects or National Key R & D Plans

If the “fast-track channel” is granted (which does not mean “approval”), the device will be allocated ‘front-of-queue’ priority throughout the registration process. The granted priority affects the classification determination, pre-clinical testing, QMS auditing, and NMPA reviewing/approving processes. Meanwhile, a specially assigned NMPA officer would check in and provide guidance throughout the whole expedited process.

This fast-track channels will greatly accelerate the registration process and Bradynuoen and help you evaluate the possibilities of your application.