The Key Points of Registration for Innovative Medical Device

By Oct 26^th, 2015, CFDA had received 262 of projects about innovative medical devices application, in which 249 of projects have been reviewed and of which just 37 are approved to apply for registration based on Innovative Medical Device Special Approval Procedure. The passing rate of innovative medical devices application is 16.4%.

According to the relevant regulations issued by CFDA, if you want to apply for innovative approval for your medical device, you firstly shall have the core technology invention patent of your product in China.
The key points of the invention patent, which you shall pay attention:

1).The patent shall be invention patent.

There are three types of patents: invention patent, utility model patent, and design patent in China. If you want to apply for innovative approval, you shall own invention patent, rather than other two types of patents.
Invention patent refers to technical proposal for product or method, including product invention and method invention.

2).Applicant shall own the invention patent in China, or obtain the invention patents or authorized to use the patents through the legal transfer in China.

The overseas invention patent cannot be used to apply for innovative approval, and it must be issued in China. And if you obtain the invention patents by transference, then you shall submit the relevant supporting documents to CFDA. However, it has to be pointed out that if you obtain the invention patents by transference, but the transferer prohibits this invention patent being used to manufacture, then this transferred patent cannot be used to apply for innovative medical device.

3).The invention patent shall be the core technology

You shall prove your invention patent can improve the performance and safety of product dramatically, so the invention patent must be the core technology. The invention patent shall involve with intended use innovation, structure transformation, performance and usage improvement, manufacturing process variation, and auxiliary means improvement.

4).While you submit the invention patent certificate, the patent specification shall be submitted at the same time. If you have not obtained the certificate yet, you can submit the supporting document which can prove your invention patent applicant has been publicized by State Council and patent specification.

If you want to know the more information of the Innovative Medical Device Approval Procedure, Please click here for further details.

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