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Service Introduction

Jiushun Enterprise Management Technology Service Co., LTD. provides service of innovative medical devices registration for you. The company has a group of experts in innovative medical devices policy and regulations to provide high quality and efficient service.

一、Data requirements of Special Review and Approval Procedure for Innovative Medical Devices

 　 （一）Medical device manufacturer certification;

 　 （二）The product of intellectual property rights and documents

 　 （三）Survey of product development process and results

 　 （四）Product technical documentation shall at least including the following:　  　

 　 1. Intended use of the product;　　 

 　 2. Product working principle or mechanism；
 　 3. Main technical indicators and determine the basis, the main raw materials, key components of the index requirements, the main production process and process chart, the main technical indicators of the test method.

 　 （五）The documentation of innovative devices, at least, should include the following:
 　 1. A new report issued by the information or the patent search agency;
 　 2. A review of the academic papers, monographs and papers published in the core journals of the value of clinical application；
 　 3. Analysis and comparison of domestic and foreign similar products already in the market application (if any)；
 　 4. Innovative content of devices and its significant value in clinical application.

　  （六）Safety risk management report。

　?。ㄆ撸㏄ackage insert (sample)。

　?。ò耍㎡ther proof the devices are in line with the procedures of the second。

 　 （九）the manufacturers letter of authorization to agents for application，and the agents should submit the following：
 　 1. The application for the innovative medical devices in China by the agency in china;　                                                        　 2. The agent's letter of commitment

 　 3.The agent's business license　　

 　 （十）Self-assurance statement of authenticity of the dossiers submitted;

二、Conditions for approval of innovative medical devices application：

 　 （一）The applicant have the product core technology invention patents in Chin in accordance with the law ,through its technological innovation activities ,or in accordance with the law by the transferee in China's invention patents or the right to use, or the core technology invention patent application has been published by the State Council　　

 　 （二）Product main working principle or mechanism is domestic initiative, product performance or safety and similar products have a fundamental improvement, technology is in the international advanced level, and has a significant clinical application value.

 　 （三）The applicant has completed the preliminary research and has the basic shape of the product, the research process is real and controlled, the research data is complete and can be traced.

三、The main reason for the failure of the application of innovative medical devices:

 　 （一）Patent, patent documents are incomplete, patent and patent content inconsistent with the project or not the core technology

 　 （二）Supporting information on the lack of significant clinical value;

 　 （三）Does not belong to the domestic initiative；

 　 （四）Does not belong to the international leading technology；

 　 （五）Product has not been finalized；

 　 （六）Check the new report is not qualified and other reasons。

四、How to meet the above conditions：

 　 （一）Product intellectual property rights and documents, Patent, patent documents are incomplete, patent and patent content inconsistent with the project or not the core technology. Note: the invention patent certificate, patent specification, the patent register a thin copy is indispensable (photocopy);

 　 （二）How to prove that the product main working principle / mechanism is the domestic first, technology in the international advanced level. Note: get the invention patent acceptance notice for the investigation of new report which should show the results: domestic or international leader (Chaxin report within 1 year);

 　 （三）The core journals and other information to prove that it has a significant clinical application value,

 　 （四）Product basic design (prototype, sample, design verification completed), the principle of work or action mechanism.

五、When to apply?

 　 Before registration test and clinical trial, after the product is basically finalized and get the invention patent certificate.