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Location: front page—Table sample—form template—public affairs form — Medical device first business variety approval form
Medical device first business variety approval form

Medical Device First Business Variety Approval Form Free Version

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  • Software licensing: shareware
  • Software size: 0.01MB
  • Software rating:
  • Software type: Domestic software
  • Update time: 2024-10-31
  • Application platform: WinAll
  • Software language: Simplified Chinese
  • Version: Free version
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Basic introduction
The first LOGO of the first paragraph of the approval form for the first business of medical devices
Medical device first business variety approval formIt is reviewed and approved by the State Food and Drug Administration and issued a new medical device product certificate. The new medical device product certificate does not serve as an approval document for the product to enter the market. The free download of the first batch of medical device variety approval form is provided by Huajun Software Park. The source file is in xlsx format. You can edit and modify the content style by downloading the source file. For more information about the download of the first batch of medical device variety approval form, please pay attention to Huajun Software Park. . Screenshot of Medical Device First Business Variety Approval Form

Tips for using the medical device first business variety approval form​​​How to prepare the approval form for the first commercial product of medical devices?
To apply for a new medical device product certificate, the following materials (in duplicate) should be submitted:
(1) Product technical report. It should include domestic and foreign dynamic analysis of this type of product, product biological properties, physical properties, chemical properties, technical performance and process technology requirements, as well as the basis for identifying product performance indicators, experimental processes and results.
(2) Product risk analysis and preventive measures taken.
(3) Novelty search report issued by a national information or patent search agency.
(4) Product quality standards and preparation instructions approved by the State Food and Drug Administration (for research and development units) or the drug regulatory department of the local province, autonomous region, or municipality directly under the Central Government (for production units).
(5) Product performance self-test report.
(6) Product type test report issued by a medical device quality inspection agency recognized by the State Food and Drug Administration.
(7) Clinical trial approval documents.
(8) Clinical trial reports issued by two or more clinical trial bases.
(9) Product instruction manual.

General Tips for Medical Device First Business Variety Approval Form

​ ​ 1: Forced line breaks within cells
By pressing alt+Enter after a certain character in a cell, you can force the cursor to the next line.
​ ​ 2: Automatic line wrapping
After typing the text in the cell, find the "Automatically wrap" button on the toolbar and you can freely switch the text between wrapping and not wrapping.
​ ​ 3: Hide the chapter list
​​Select the first line, hold down [shift+F] to open the "Find and Replace" dialog box, "Remarks to find all, hold down shift+A to select all, then close the dialog box, hold down [ctri+0] to hide
​ ​ 4: Quickly select specific columns
​​Select the table area, click the "Create from selected content" dialog box under the [Formula] tab, select "First Row", after the settings are completed, open the name box in the upper left corner, click the corresponding list to jump to the specified column.

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Medical device first business variety approval form

Medical Device First Business Variety Approval Form Free Version

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