I     All application documents should be bound into book form.

II    The contents of items in the application documents should be written in the first page. All application documents should be made in the order specified in “Basic Requirements”. Each item of documents should be separated by intermediate paper with tag in which item number is marked.

III   Application documents should be submitted in one copy (product standard and product instruction book should be in two copies). Another copy is required for initial registration.

IV   All documents compiled by applicant and agent should be clearly and completely printed in A4 paper without alteration. Any and all documents issued by government agency and other official organizations should be provided in original size and may not be divided if in book form.

V    All copies of application documents shall be clear and exactly same as the originals.

VI   All contents in application documents (application form, approval of marketing, product standard, test report, instruction book) shall be consistent with each other. Trade name or English name of the product, if any, should be marked.

VII  All application documents should be made in Chinese, if translated from foreign language, submitted together with original language version.

VIII Applicant shall timely submit supplementary documents in the event of the circumstance described in Article 63 of Management Measures for the Registration of In-Vitro Diagnostic Reagent (Trial) and in any other cases may not make such supplementation on its own after the acceptance of application documents.

IX   Product name shall be subject to the nomenclature principle specified in Management Measures for the Registration of In-Vitro Diagnostic Reagent (Trial).

X    Electronic format is also required in the submission of the following application documents:

(i)       Application Form

(ii)     Abstract of summary documents, including: prospective use of product (within 500 Chinese characters), product description (within 200 Chinese characters), statement on biosafety (within 100 Chinese characters), summary and evaluation of main research findings (within 200 Chinese characters) and others (within 200 Chinese characters);

(iii)   Proposed product standard and statement; and

(iv)    Product instruction book.

Except Application Form, the remaining documents above should be made in editable and modifiable Word document.