QMS conformity survey submission documents
Updated: July 2024, 9
A QMS conformity survey is conducted on a manufacturer or registered manufacturer at the time of reviewing a manufacturing/sales approval application or certification application, and investigates whether proper manufacturing is being carried out in compliance with the QMS ministerial ordinance. Thing.
There is a written survey and an on-site survey at the manufacturing site.
Of course, an investigation is conducted when a new (or complete change) application is made, but renewal investigations are also conducted every five years.
New (or completely changed) documents to be submitted
The documents to be submitted when new or completely changed are as follows.
| What is specified in the investigation procedure notice | 1. A copy of the application form for manufacturing and sales approval for the applied item or the application form for approval for partial change in approved matters (if based on the export notification for export medical devices, etc., the notification form) | |
| 2. Copy of approval form for partial changes to approved items and minor change notification form since the previous survey | 〇Checkpoint〇 In the case of a complete change, submit a partial change approval form for the approved item obtained since the previous survey by PMDA or the prefecture, a copy of the submitted minor change notification form, and a copy of the description improvement notification if it has already been submitted. | |
| 13485. ISOXNUMX certificate and audit report, on-site inspection report by other inspectors conducted within the past three years from the date of application for conformity inspection of the facility to be inspected, certificate or inspection report of the other country based on MOU, etc., copy of conformity certificate from foreign authority, etc. | 〇Checkpoint〇 Submit the required documents below ①ISO13485 certificate and audit report ② Reports of on-site inspections by foreign authorities, excluding third-party certification bodies ③ Certificates or survey reports from the partner country based on MOUs, etc. ④Certificate of conformity issued by foreign authorities | |
| 4. Overview of manufacturing process for surveyed items | 〇Checkpoint〇 ・All facilities can be identified from receiving component parts to shipping decisions. ・Description that shows the details of the specific work | |
| 5. Materials that can confirm the outline of activities carried out at each survey target facility and the interrelationship of the quality control supervision system at each survey target facility | 〇Checkpoint〇 ・About all registered manufacturing facilities ・Overview of activities | |
| Materials required by compliance survey implementer | 1. Materials related to the facility surveyed (1) Outline of the facility surveyed (2) Layout of the facility surveyed (3) Floor plan of the facility surveyed, list of main facilities and equipment related to manufacturing, and list of main facilities and equipment related to testing | 〇Checkpoint〇 (XNUMX) Overview ・Manufacturers, designated foreign manufacturers, etc. of medical devices, etc. and all registered manufacturers ・For overseas manufacturers, the language used for filling out the form may be English. ・If the manufacturer, etc. and the registered manufacturing facility are the same facility, it is OK to list them together. (2) Layout plan ・All registered manufacturing facilities except design facilities ・Aerial photographs are acceptable for drawings (3) Plan view ・Clearly identify manufacturing areas, clean rooms, etc. |
| 2. QMS-related materials (1) Organization chart of survey subjects (2) Quality control supervision system standards (3) List of management documents | 〇Checkpoint〇 (1) Organization chart Regarding manufacturers and distributors, please describe the relationship with the safety management department or departments related to safety management. (2) Quality control supervision system standards copy of original (3) List of management documents Can be omitted if there is sufficient material in the quality manual | |
| 3. Materials related to the item (1) List of child items related to the applied item (2) Overview of product standards (3) Documents such as package inserts that provide an overview of the product (4) Status of validation in the manufacturing process | 〇Checkpoint〇 (2) Overview If multiple facilities are involved in each item, the documents, etc. of each facility should be appropriately described in the product standard so that the link can be seen. (3) Documents that provide an overview of the product, such as attached documents. If the product being applied for has undergone validation, submit a list of the process name, the facility where validation was performed, and the time of validation (approval date of the final report). | |
| 3. Materials related to Chapter XNUMX of the QMS Ministerial Ordinance (1) Procedures, etc. related to reporting defects to manufacturers, etc. (2) An oath stating that the domestic quality operations manager meets the requirements. (3) Procedure manual for the work of the domestic quality operations manager (4) Written agreement with registered manufacturing facility, etc. (5) Procedures for processing notifications from repair companies and used product sellers or lenders, and ensuring quality at medical device sellers or lenders. | 〇Checkpoint〇 (3) Procedure manual ① Oversight of domestic quality control operations ②Decision on shipping to market ③ Collection of information regarding product quality, etc. (including changes that affect product quality) and reporting to managers, etc. ④ Product collection ⑤ Reporting of post-market safety information to the safety management department, etc. (4) Written agreement If the marketing authorization holder does not have a direct agreement with a registered manufacturing facility and collects information indirectly through another registered manufacturing facility, a copy of the agreement between the said registered manufacturing facility and the other registered manufacturing facility must be submitted. |
*Separate materials may be required as necessary.
Renewal (every 5 years) Submitted materials
The documents to be submitted for renewal every five years are as follows:
| What is specified in the investigation procedure notice | 1. Copy of approval form for partial changes to approved items and minor change notification since the previous survey | |
| 13485. ISOXNUMX certificate and audit report, on-site inspection report by other inspectors conducted within the past three years from the date of application for conformity inspection of the facility to be inspected, certificate or inspection report of the other country based on MOU, etc., copy of conformity certificate from foreign authority, etc. | 〇Checkpoint〇 Submit the required documents below ①ISO13485 certificate and audit report ② Reports of on-site inspections by foreign authorities, excluding third-party certification bodies ③ Certificates or survey reports from the partner country based on MOUs, etc. ④Certificate of conformity issued by foreign authorities | |
| 3. Overview of manufacturing process for surveyed items | 〇Checkpoint〇 ・All facilities can be identified from receiving component parts to shipping decisions. ・Description that shows the details of the specific work | |
| 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 | 〇Checkpoint〇 ・About all registered manufacturing facilities ・Overview of activities | |
| 5. A summary of any recoveries since the last periodic compliance inspection. | 〇Checkpoint〇 Include the start date of recall, product name, details of recall, class classification related to recall, name of related manufacturing site, etc. | |
| 6. oath | ||
| Survey Guidelines Notification Form 4-2. (6) “Materials required by compliance survey implementer” | 1. Information on the surveyed facilities (1) Overview of the surveyed facilities (2) Layout map of surveyed facilities (3) Floor plan of the surveyed facility, list of main facilities and equipment related to manufacturing, and list of main facilities and equipment related to testing and inspection. | 〇Checkpoint〇 (XNUMX) Overview ・Manufacturers, etc., designated foreign-manufactured medical device manufacturers, etc., and all registered manufacturing facilities ・For overseas manufacturing sites, the language to fill in can be English. ・If the manufacturer, etc. and the registered manufacturing facility are the same facility, it is OK to list them together. (2) Layout plan ・All registered manufacturing facilities except design facilities ・Aerial photographs are OK for drawings. (3) Plan view ・Clearly identify manufacturing areas, clean rooms, etc. |
| 2. QMS-related materials (1) Organization chart of survey subjects (2) Quality control supervision system standards (quality manual) (3) List of management documents | ||
| 3. Materials related to the item (1) Copy of child item list (Form 3) and standard conformity certificate pertaining to the application item (2) Overview of product standards (3) Documents that provide an overview of the item, such as package inserts (4) Implementation status of validation in manufacturing process (5) Annual manufacturing and sales volume for the past three years (6) For medical devices that use biological raw materials, documents showing that they have been inspected for quality problems from the perspective of ensuring safety. | 〇Checkpoint〇 (2) Overview If multiple facilities are involved in each item, the documents, etc. of each facility should be appropriately described in the product standard so that the link can be seen. (3) If there is a process in which validation was performed for the applied item, submit a list of the process name, facility and implementation period (date of approval of final report). | |
| 3. Materials related to Chapter XNUMX of the QMS Ministerial Ordinance (1) Procedures, etc. related to reporting defects to manufacturers, etc. (2) An oath stating that the domestic quality operations manager meets the requirements. (3) Procedure manual for the work of the domestic quality operations manager (4) Written agreement with registered manufacturing facility, etc. (5) Procedures for processing notifications from repair companies and used product sellers or lenders, and ensuring quality at medical device sellers or lenders. | 〇Checkpoint〇 (3) Procedure manual ① Oversight of domestic quality control operations ②Decision on shipping to market ③ Collection of information regarding product quality, etc. (including changes that affect product quality) and reporting to managers, etc. ④ Product collection ⑤ Reporting of post-market safety information to the safety management department, etc. (4) Written agreement If the marketing authorization holder does not have a direct agreement with a registered manufacturing facility and collects information indirectly through another registered manufacturing facility, a copy of the agreement between the said registered manufacturing facility and the other registered manufacturing facility must be submitted. |
*Separate materials may be required as necessary.
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.
