Publicity List of Innovative Medical Devices collected from CMDE - updated by 2015.9 - Regulatory News - Medical Devices

It was on Mar 1^st, 2014 that The review and approval for Innovative Medical Devices came into force, and it was in this year that a large number of companies long for being approved of this special procedure due its incredible benefits.

CFDA enact the special review and approval procedure for innovative medical device to inspire the research and innovation of medical devices, and aim to encourage the promotion and application of advanced techniques on medical device. If your product pertains to these amazing innovative medical devices, it will make great sense to process your registration in the priority list, that is, it may save you a great number of time, and even it will save you a dramatic cost from which is the CFDA administrative fee if you are just running a tiny/small business currently.

CFDA defines the innovative medical devices as:

The applicant, through his/her technological innovation activities, possess a core technology invention patents of the product by Chinese law, or possess invention patents or the right to use by transferring; or core technology patent is published by the Patent Administration of the State Council.
Main mechanism of the products is initiated in china, and the performance or safety of the products has been greatly improved compared to similar ones. The technology of the products is in the international advanced level, and has significant clinical application value.
The applicant has completed preliminary research and has the basic product sample all research work real and controlled, research data integrated and traceable.

What are benefits of being innovative medical devices:

	Items	Innovative Medical Devices	Regular Medical Devices
Technical Evaluation	Gov. Authority	Innovative Priority Office	CMDE (center for medical device evaluation)
	Duration	40 business days	93 business days for Class II 123 business days for Class III
	Cost	Free only for small/tiny business	Please see here
Administration Procedure	Gov. Authority	Innovative Priority Office	CMDE
Administration Procedure	Duration	10 business days	30 business days

Publicity List of Innovative Medical Devices Reviewed by CMDE - updated by 2015.9:

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