Documents to submit for certification application
Updated: July 2024, 9
Designated controlled medical devices that fall under Class II can be sold domestically by conducting medical device manufacturing and sales certification and obtaining certification from a certification body.
Applications are made to third-party certification bodies (13 organizations) rather than to the PMDA.
When applying, you will need to submit the following documents:
When applying for a new application
≪1≫Certification application form, etc.
| 1 Application form Application for certification to manufacture and sell designated controlled medical devices (Form 64 (1)) (Form 64 (3) for foreign countries) | 〇Checkpoint〇 ・Does the document include any cited appendices or attached documents (draft)? ・Is the applicant information (name, address) written in the margin of the copy the same as the information on the register? ・If applicable to No. 0128 No. 6 from Yakushoku Kiku, the notes section: Is it written as "Application based on No. 22 No. 1 from Yakushoku Kiku dated January 28, 0128"? ・Are there any extra materials or materials in excess of the required quantity? |
| 2 Attachments (STED) ① Summary ② Compliance with basic requirements ③ Information on the equipment ④ Outline of design verification and validation documents ⑤ Attached documents (draft) ⑥ Risk management ⑦ Manufacturing information | 〇Checkpoint〇 ・Is STED created based on Yakushokuki Sanpatsu 0210 No. 1? ・Does the instruction manual meet JIS requirements? ・Are the matters listed in No. 0210 of Yakushoku Ki Sanpatsu No. 1 No. 1 (information regarding testing facilities and testing, signature of the issuer, etc.) included? - Is it clear which materials indicate compliance with which standards? ・Is there a signature or name and seal (representative seal) by the applicant's representative? |
| 3 Copy of permit Manufacturing and sales business license, manufacturing business registration certificate, foreign manufacturer, renewal application, business license application, etc. | 〇Checkpoint〇 ・If the QMS conformity survey is omitted, a copy of the standard conformity certificate. Valid for omission. ・Is it the latest version within the expiration date? ・If there have been any changes or updates, use the latest application form as a document that can confirm the location in the manufacturing and sales business register. |
In addition, the attachments are divided into the following categories:
·instruction manual
・Certificate of conformity
・Self-declaration
The required materials differ slightly depending on the medical device that requires certification and each certification body.
≪2≫Compatibility investigation application form
| 1 Application form Application for Compliance Inspection of Designated Control Medical Devices (Form 67 (1)) (Form 67 (2) for foreign countries) | 〇Checkpoint〇 - If there are already certified or approved items for which the conformity survey will be omitted with the "Certificate of Conformity" issued in this application, create and submit a "List of Child Items" in a separate sheet. ・Are all facilities targeted for investigation included in the application? ・Are there any extra materials or materials in excess of the required quantity? |
| 2 Attachment Field survey ・Copy of the quality control supervision system standard ・List of management documents ・Organizational chart of the facility to be inspected ・Layout and organizational chart of the registered manufacturing facility ・Flow chart of the manufacturing method ・Sterilization validation report *In the case of a complete change, documents related to the above changes *In the case of a regular inspection, submission of a written declaration *Other documents required depending on the content of the inspection | 〇Checkpoint〇 ・Does the copy of the latest version of the quality management and supervision system standards (quality manual) include a page showing that it has been approved? ・For overseas factories, if the language is other than Japanese or English, is a translated version attached? ・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? ・Do you know the names of the supervisor, manager, and responsible engineer, and the relevant departments? - 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? ・For an overview of the manufacturing process of the item, refer to the administrative communication dated October 26, 10, "Regarding materials to be submitted when applying for a QMS compliance survey." ・Are there descriptions that make it easy to understand the details of manufacturing process activities for each quality control supervision system? - Is it possible to confirm how the manufacturer, etc. manages the quality management system of each registered manufacturing facility? |
| 3 Attached documents Document investigation ・Copy of QMS investigation results report of on-site investigation conducted within the past three years or copy of ISO audit report ・Product standard or DMR ・Sterilization validation procedure and report ・Design and development validation report *Other necessary documents depending on the contents of the application or investigation | 〇Checkpoint〇 ・It is not necessary to submit a copy of the product standard document that is referenced in the product standard document. ・Copies of product standards are available in Pharmaceutical Food and Drug Administration No. 0827 No. 4, Chapter 6, Section 3 6. Does it meet the requirements of Article 6(5)? ・Is the copy of ISO13485 certificate etc. the latest version? (If you have submitted it earlier, it is not necessary here) ・If the QMS conformity survey is omitted, a copy of the standard conformity certificate. Valid for omission. ・A copy of the latest application form for changes, updates, etc. is required to confirm the name and location of the head office. (Not a business license) ・Tests, inspection methods, or forms (forms), such as inspection procedure manuals, to be conducted when manufacturing (including storage) the applied item at each registered manufacturing facility are required. ・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. - A copy of the conformity investigation results report, not the investigation results summary report. |
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.
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