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About

The List of Innovative Medical Devices Which Have Been Approved -updated by 2015.12

Jan 11, 2016 from CIRS by Windy

Up to now, CFDA has approved 46 medical devices to obtain their registration certificate through Special Approval for Innovative Medical Device which came into force on March 1^st 2014.
By collecting and sorting all innovative medical devices into different groups, we found that those medical devices which are mainly involved in the following filed:

Absorbable medical device: such as Absorbable Dural Sealant Medical Adhesive; Drug-eluting Bioresorbable Vascular Scaffold System; Biodegradable Magnesium Bone Fixation Screws, etc.
Gene detection: such as Diagnostic testing Kit of Trisomy 21,18 & 13; DNA Sequencing instrument; Methylated DNA Detection Kit for Colorectal Cancer (PCR Fluorescent Probe); Pathognic organisms of respiratory tract Nucleic Acid Detection Kit (Isothermal Amplification Chip), etc.
Artificial ocular tissue: such as Biological Artificial Cornea; Tissue-engineered Human Corneal Endothelium; Acellular Cornea Stroma; Intraocular Lens (IOL), etc.
Cardiovascular medical device: such as Left atrial appendage (LAA) Occluder System; Percutaneous Artificial Heart Valve System; 3D Cardiac Electrophysiological device, Three-layer weaved Small-caliber Artificial Blood Vessel, etc.
Use of nervous system: such as Dual-channel device capable of delivering bilateral stimulation with wireless programmable function; Medical Artificial Nerve Graft; Vagal stimulation system.

Fortunately, for those products, they are regulated by Special Approval for Innovative Medical Device, the time of examination and approval can be reduced. If you want to know more information about Innovative Medical Device Special Definition and Advantage, please click those words with color, as well as Innovative Medical Device Special Approval Procedure.
Publicity List of Innovative Medical Devices Reviewed by CMDE - updated by 2015.12
DOWNLOAD HERE!

More information, please contact : Windy@cirs-group.com

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md@cirs-group.com