CFDA Medical Device Classification Workflow For Overseas Companies

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CFDA Medical Device Classification Workflow For Overseas Companies

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Here is the latest CFDA publication about Medical Device Classification Workflow For Overseas Companies:

A.  The application method

Applicants can apply by visiting http://www.nifdc.org.cn/qxbgzx/CL0482/, clicking into the “medical device classification information system “, filling out the “classification application form” after registration, and uploading other application documents.

Print the “classification application form” online and seal on the perforation of the form and other application documents (should be completely same with uploaded application documents). The documents related to imported, Hong Kong, Macao and Taiwan products should be posted to Medical Device Standard Management Center of China Food and Drug Administration (Address: Room B404, Building 4, No.31,Hua Tuo Road, Biomedical Industry Base, Daxing District, Beijing, China).

B. The requirements to the application documents

(a) Classification application form

(b) The photos and/or structure charts of products

(c) Technical requirements and brochures of products (samples)

(d) Import products certificate (if any)

(e) Self-assurance statement to the authenticity

(f) Other documents related to the product classification.

Newly developed products which had not been included in the “classification catalogue” and other documents should at least also submit:

  • The analysis and comparison with the relevant products that had entered the domestic and overseas markets, products that had listed on the “classification catalogue” or the “classification notification”, and the judgment basis for why the newly developed products had met the standard of products which had not listed on the “classification catalogue”;
  • Academic publications, monographs and summary documents (if any) published publicly in the core journals, which could  adequately describe the clinical application value of the products;
  • Creative contents of the products;
  • Information or search report issued by patent search institutions.

All application documents should be in Chinese. Original text should be provided for the information translated from foreign languages.

C. The inquiry of application statue and result

Applicants can inquiry the application status and result by clicking the “view the flow chart” button on the “action bar” after log in the “medical device classification definition information system “.

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