Approval request letter

file name

Key points

1

Medical equipment manufacturing booklet

[Additional fees]

・Summary of additional fees

・Matching oath book

・Additional text

・Performance report (report on performance)

・Adhesiveness/Durability

・Performance (performance test report)

・How to use *If necessary

・Wind management table

・Information on sterilization process *Subject to necessary circumstances

・Confirm whether or not it is correct or not. Name of the annexed table of the Enforcement Ordinance for the Machinery Law (Example: Machinery Equipment ○○ △△).

・If one item belongs to many categories, under different circumstances, please record the root name, record the common name, and determine the belonging category.

・Whether or not the song name is correct, whether the song name is correct or not, the characters used are Japanese numbers.

・Purpose or effect of use.

・Right or wrong record shape, conclusion principle.

・Information regarding the combination of products, whether or not the name of the medical device, the name of the medical device, and the name of the manufacturing method, etc. Contents. A record of the progress made in the approval/disapproval of the combined medical equipment notification (educational machine No. 0331002, March 21, 3).

・Is it correct or not? Please refer to the "shape, sum principle" in this article. (Excluding unnecessary records such as medical equipment procedures, etc.)

・Comparative evaluation of performance and safety.

・How to use the correct or incorrect record.

・Comparative information regarding the current manufacturing process, confirmation of demand, component parts, etc. for combination medical equipment (Notification No. 21 of March 3, 31).

・What is the method of sterilization?

・This is a manufacturing company that manufactures Japanese music products.

2

Testimonials for completing the exam

file name

Key points

1

Medical equipment registration book

[STED formal additional fees]

・Comparison of similar medical equipment

・Basic requirement standard conformity (conformity declaration)

・Summary of design and rationality confirmation book

・If you are checking multiple items at the same time, and if you are checking the list of items owned by you or checking the registration form, please be sure to include the original name of the first item in the list. (This is the second and subsequent item, the attached confirmation booklet (sealed), the red frame for the book.)

・“Category” The terms and conditions of the legal regulations regarding medical equipment and medical equipment. (Example: Article 33, Section 1, Item 1, A (1))

・“Category” The contents of the book are correct or negative.

・“Name (general name, song name)” 栏中所记载记彽认请书 “Name (general name, song name)” 栏中所 记载记彽认请书 “名(General name, 销售名)” 栏中所 记载记彽认请书。

・“The price for the price” is correct.

・Confirm the application date, applicant, contact method, etc.

・Articles related to the terms and conditions of the aircraft specified for the transfer, whether or not it is approved.

・Whether or not to use JIS A4 paper, Japanese selection, inclusion list, double-sided stamp, and page link.

・Is this correct or not? Please refer to the attached materials for reference.

・The actual property is currently being tested, and the description of its pros and cons has been completed. As a result, the validity of the testimonials for the production of instruments other than the items reported for use is confirmed.

- Includes the number of overseas examinations, literature materials, etc., and the Japanese translation (summary version).

・Reference notification system for supplementary materials fees (STED). Whether or not the application is based on the purpose of the request, excluding additional items that are not required.

・Clearance of production completed statement

・Is this correct or not? Please refer to the source of the financial aid.

・Is it right or wrong? Original document of “Self-Declaration Book (Affiliate Declaration Book)”.

・Is it correct or not? Article 41, Article 3 of the Medical Equipment Law, Article 42, Article 2.

・Under the circumstances of the new raw materials used, we will proceed with the biological safety review.

2

Examination completion book

・The original document with proof of completion. Whether or not the original matter is attached to the original matter, whether or not it is attached to the written statement and the original matter is stamped.

・Required items (minimum comprehensive): item, name of the test machine, location of the test machine (if it is external), identification of the test report (introduction) Column number etc. ), test method, test book information, test date, test result, player's name, etc.

3

Request for certification of foreign manufacturing products

・Attestation statement for applicant and corporation.

・When the petitioner is a corporation (when the petitioner is a corporation, the director of the company comprehensively conducts business), please clarify whether or not it is valid. As a result, it is a foreign sentence, and whether or not it is a translation of the above-mentioned translation.

・Whether or not you agree to confirm the selection process and make a commercial statement.

・When there was a partial change, the contents of the 72nd to 74th editions were not changed, etc., and the explanation was omitted in the note section or the statement, etc., due to the additional reasons.

XNUMX

oath book

・A corporation defined in Article 23, Section 2-17, Subsection 2 of the Law.

5

Certification documents for the selection and purchase of commercial products

6

Permissible book stamp

・Manufacturing sales certificate, manufacturing industry certificate, foreign manufacturer, renewal application book or person's license certificate.

7

power of attorney

1

FD sealing surface

2

oath book

3

Personal declaration of quality

XNUMX

When the petitioner is a corporation, the applicant's qualifications and the corporate text

5

Selection certification letter

6

Manufacturer's license

7

Record of manufacturing defects of foreign-manufactured medical equipment, etc.

1 Approval of partial changes and amendments to the minor changes and amendments made since the next meeting

・Confirmation that the manufacturing industry is allowed to manufacture the product.

2 ISO 13485 certification book, etc., the implementation of the implementation of the program, etc. within XNUMX years of the date of the establishment of the program, etc. Certification book or report on foreign authorities, etc. Confirmation of the confirmation book for the Q&A

・Is this the latest version of the book?

3 Outline of the production process for the intended product

4 An overview of the operational activities of each program, as well as mutually interactive resources for the quality management system of each program.

・Do you have any knowledge of the manufacturing process (judgment of purchase to market) and the specific process details of each customer's installation?

5 As a result, the first periodic application program will be followed by a summary of the demand provision.

6 Covenant Book

7 Tuning test design support materials

(2) Overview of training program design (Sequence XNUMX)

(2) The layout of the training program

(3) Plane design for the design of the program, cleaning of the main equipment for the design and construction, and cleaning of the main equipment for the design and construction, and the cleaning of the main equipment for the design

・Confirm the location of each factory, manufacturing area, etc. from the geographical area of ​​the site and the layout of the manufacturing facility. (Excluding design).

・Information regarding the name and department of the management supervisor, manager, and responsible engineer.

8 Sub-item cleanup and application item compatible standard conformity confirmation stamp

・If you have borrowed the item, omit the ``standard compatibility check'' and get the confirmation of the compatibility test, or someone has approved the item, you can request that the ``child item clearance'' be submitted.

・If you have obtained a standard conformance for a group of different products, you may have to reduce the amount of work required to adjust the actual fit during the original application.

・As a result, if the previous letter was provided, there would be no need for further submission.

9 Annual music volume for the past three years

1

Tunnel diagram structure

2

Quality management system standard book

3

Materials related to literature system (Management of literary materials)

XNUMX

Product description overview

5

Additional documents, etc., general materials for approved items

6

The manufacturing process and actual implementation information

7

Use of biologically derived raw materials for medical equipment, statement of demand and guarantee of safe angle output, whether or not the quality of the cutting process is questionable.

8

Notification of progress in production, sales, etc., mutual operation procedures, etc.

9

Attestation of domestic product quality work and compliance of the paying person

10

Domestic quality industry management procedures

11

Reading book of Yoju Seisakusho etc.

12

If you are a self-repair business or a two-handed purchase business or a tax purchaser, you will receive a notice on how to purchase a product, a medical equipment sales company, or a product quality operation manual.