CFDA Released a New Notice about “The Related Work for Regulating the Medical Device Classification.”

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On October 10th, the CFDA released a new notice about The Related Work for Regulating the Medical Device Classification.

Here are the highlights:

1.     For new medical devices that have not yet been listed in a “classification catalog” or medical devices that are waiting for classification notification by the CFDA, applicants should submit a classification application in CFDA classification system.

Here is the process:

a.      Go to “Medical Device Classification Information System” website ( http://www.nifdc.org.cn/), sign up in the system, fill out “Classification Application Form” and upload other materials.

b.     Print out the Classification Application Form and mail it to the relevant CFDA department along with other application materials.

c.      Application materials including:

·       Classification Application Form

·       Product picture/product structure diagram

·       Product technical standards and IFU (sample)

·       Import listing proof materials (if applicable)

·       Self-declaration of materials authenticity

·       Materials related to other product classification

d.     Applicants could log in to the Medical Device Classification Information System to track the application status and results.

2.     Provincial CFDA should be responsible for reviewing provincial classification applications. Provincial reviewers could determine the classification or give expected classification comments.

3.     CFDA Medical Device Standard Management Center is responsible for taking care of the application from import products or products from Hong Kong, Macao, and Taiwan.

4.     During the technical review process, if the Medical Device Technical Review Department finds out that the product is not in the Classification Catalog or doesn’t get a classification result from the Classification System, the Technical Review Center should determine the classification based on related CFDA regulations.

5.     This notice is not applicable to innovation of medical device and combination products.

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