Application documents for approval application
Updated: July 2024, 9
Medical device items that pose a high risk to life and are directly connected to life-threatening situations require "medical device manufacturing and sales approval" as Class III/IV (some Class II as well).
Applications should be made to the PMDA (Pharmaceuticals and Medical Devices Agency).
When applying, you will need to submit the following documents:
①Approval application form
| Document name | Checkpoint | |
| 1 | Medical device manufacturing and sales approval application form 【Attachment】 ・Summary of attached documents ・Declaration of conformity ・Attachment document ・Performance test report (testing agency report) ・Stability ・Durability ・Performance (performance test report) ・How to use *If necessary ・Risk management table ・Information on sterilization process *If necessary | ・Are the numbers and category names (e.g., machinery and equipment ○○ △△) listed in Attached Table 1 of the Pharmaceutical and Medical Devices Law Enforcement Ordinance correctly entered? - If an item falls into multiple categories, is the category determined from the common name written in the name column? - Is the brand name listed, and is the brand name made up of only alphanumeric characters? - Is the purpose of use or effect stated? ・Are the shape, structure, and principle described? - In the case of a combination product, only the names of the constituent medical devices are listed, and items such as approval (certification/manufacturing and sales notification) numbers for the constituent medical devices are summarized in the "manufacturing method" column. Is there? Or is it stated in the Combination Medical Device Notification (No. 21 from Pharmaceutical Shokuki, dated March 3, 31)? ・Are the raw materials listed in accordance with the information listed in the "Shape, structure, and principle" column? (Excluding cases where description is not required, such as medical device programs.) ・Are standards related to performance and safety listed? ・Are there instructions on how to use it? ・For combination medical devices that require confirmation of the sterilization status of their components (Notice No. 21 from Yakushoku Kikai dated March 3, 31), are they described in process flow diagrams or tables? - If the sterilization method is "radiation" or "other", is the sterilization method specifically described? - Is the manufacturing site of the item being manufactured and sold listed? |
| 2 | Statement on test results |
② Compliance survey application form
| Document name | Checkpoint | |
| 1 | Medical device investigation application form [Attachments in STED format] ・Comparison with similar medical devices ・Conformity to basic requirements standards (declaration of conformity) ・Summary of design verification and validation documents | ・When applying for multiple items at the same time and listing all of the items in the review/investigation application form, the original copy must be attached to the approval application form for the item listed first in the brand name column of the review/investigation application form. Is there? (For the second and subsequent items, attach a copy of the examination/investigation application form and enclose it in a red frame.) - Are the provisions of the Pharmaceutical and Medical Device Act Related Fee Ordinance accurately stated in the "Classification" column (e.g., Article 33, Paragraph 1, Item 1, A (1))? - Is the content in the "Category" column consistent with the description in the "Category" column of the approval application form? - Is the "Name (generic name, brand name)" column consistent with the description in the "Name (generic name, brand name)" column of the approval application form? - Is the correct amount in accordance with the Pharmaceutical and Medical Device Act-related Fee Ordinance listed in the "Amount of Examination Fee or Investigation Fee" column? ・Are the application date, applicant, contact information, etc. correct? ・Is there a document attached that proves that the payment was made to the designated account of the organization? - Is the paper JIS A4, Japanese text, a table of contents written, double-sided printing, and pages running through? ・Have a list of attached materials and a list of reference materials been created? - Are the test specimens described in all tests conducted? If a device other than the one for which the application was made is used for the specimen, is the validity of the test specimen used described? ・When attaching foreign test data or literature, are the Japanese translations (summary versions) attached? ・Are the attached documents (STED) created with reference to the notification? Are items that do not need to be attached removed in accordance with the characteristics of the application item? ・Has a list been created? ・Are the sources of the materials used for comparison listed? ・Has the original copy of the “Self-Declaration of Conformity (Declaration of Conformity)” been attached? - Is the declaration of conformity written in accordance with Article 41, Paragraph 3 of the Pharmaceutical and Medical Device Act and Article 42, Paragraph 2 of the Pharmaceutical and Medical Device Act? ・If new raw materials are used, have biological safety evaluations been conducted? |
| 2 | exam result | - Is the original copy of the test report attached? If the original cannot be attached, is a statement that it is a copy of the original attached? ・The test report attached to the application form must include the necessary information (at least the title, name of the testing laboratory, location of the testing laboratory (if conducted at an external testing facility), and identification of the test report (serial number). etc.), test method, test sample information, test date, test results, issuer's signature, etc.)? |
| 3 | Certification documents for foreign manufacturing and sales approval application | ・Documents proving that the applicant is a corporation. - Documents clarifying whether the applicant (if the applicant is a corporation, including its executive officers) is a person stipulated in Article 23-XNUMX-XNUMX, Paragraph XNUMX of the Act are attached. Has it been done? If it is in a foreign language, is a Japanese translation attached? ・Are documents proving that the designated marketing authorization holder has been appointed attached? ・In the case of a complete change, is the reason for omitting the attachment of the relevant certificate, such as no change in the contents of check items No. 72 to 74, explained in the notes section of the approval application form or in the written statement, etc.? |
| 4 | Oath | ・Certify that the applicant is a corporation, clarifying whether or not the applicant is a person stipulated in Article 23-2-17-2 of the Act. |
| 5 | Documents proving that a designated marketing authorization holder has been appointed | |
| 6 | Copy of permit | - Manufacturing and sales business license, manufacturing business registration certificate, foreign manufacturer, renewal application or business license application, etc. |
| 7 | power of attorney |
③QMS conformity survey
| 1 | FD cover |
| 2 | Oath |
| 3 | Quality Officer Oath |
| 4 | If the applicant is a corporation, documents proving that it is a corporation |
| 5 | Documents certifying appointment |
| 6 | Manufacturing and sales license |
| 7 | Items listed in the manufacturing and sales approval ledger for foreign-manufactured medical devices, etc. |
Regular (continuation/renewal) application
①Submit when applying for QMS
| 1 Copy of the partial change approval form and minor change notification form since the previous survey | ・It is not a manufacturing and sales license or a manufacturing license (registration). |
| 2 ISO13485 certificate, etc., on-site investigation report by another investigator conducted within the past three years from the date of application for compliance investigation at the facility to be investigated, certificate or investigation of the partner country based on MOU, etc. Copy of report, certificate of conformity issued by foreign authorities, etc. | ・Is it the latest version within the expiration date? |
| 4 Materials that can confirm the outline of activities carried out at each survey target facility and the interrelationship of the quality control and supervision systems at each survey target facility | - Are all facilities involved in the manufacturing process (from receiving components, etc. to determining shipment to the market) and the specific process details at the facilities known? |
| 5 If there has been a recall since the last periodic compliance inspection, a summary of it. | |
| 6 Written oath | |
| 7 Materials related to survey target facilities (2) Overview of surveyed facilities (Form XNUMX) (2) Layout map of surveyed facilities (3) Floor plan of the surveyed facility, list of main equipment and equipment related to manufacturing, and list of main equipment and equipment related to testing and inspection | ・Are there drawings of the site and surrounding area and a floor plan of the registered manufacturing site, and are storage locations, manufacturing areas, etc. visible? (Excluding design facilities). ・Do you know the names of the supervisor, manager, responsible engineer, and related departments? |
| 8 Copy of child item list and standard conformity certificate for the applied item | - If there are already certified or approved items that require a "Certificate of Conformity" and a conformity survey is omitted, create and submit a "List of Child Items" in a separate sheet. ・If you have obtained standards conformity certificates for different product groups and are trying to reduce the number of on-site compliance inspections with this application. - Not required if submitted before creating the estimate. |
| 9 Annual manufacturing and sales volume for the past three years |
② Materials to be submitted after receiving the written investigation notification
| 1 | Organizational chart of survey subjects |
| 2 | Quality control supervision system standards |
| 3 | Materials related to document system (list of management documents) |
| 4 | Overview of product standards |
| 5 | Documents that provide an overview of the item, such as attached documents |
| 6 | Validation implementation status in manufacturing process |
| 7 | For medical devices that use biological raw materials, documents showing that they have been inspected for quality problems from the perspective of ensuring safety. |
| 8 | Procedures, etc. related to reporting defects to manufacturers, etc. |
| 9 | A declaration that the domestic quality operations manager meets the requirements |
| 10 | Procedure manual for the work of the domestic quality operations manager |
| 11 | Agreement with registered manufacturing facility, etc. |
| 12 | Procedures for processing notifications from repairers and used product sellers or lenders, and ensuring quality at medical device sellers or lenders. |
For consultation regarding permits and licenses regarding medical devices, please contact Support Administrative Scrivener Corporation.
At Support Administrative Scrivener Corporation, we provide application support and consulting regarding the Pharmaceutical and Medical Device Act, from those newly entering the medical device industry to existing marketing distributors, manufacturers, and distributors.
Applications for medical devices are highly specialized and can be said to be one of the fields in which there are few administrative scriveners who can handle them.
Our staff has a track record of applying in all prefectures across the country. Please contact us by all means.
