QMS construction for manufacturing and sales industry
Updated: July 2026, 8
Compliance investigations with standards for manufacturing control and quality control of medical devices, etc. will now be conducted for each quality control supervision system, including the product's marketing authorization holder and all registered manufacturing facilities, instead of the previous investigation for each manufacturing facility. Changes have been made to a new regulatory system.
In line with this change, the "Ministerial Ordinance on Manufacturing Control and Quality Control Standards for Medical Devices and In-Vitro Diagnostic Reagents" (abbreviation: QMS Ministerial Ordinance) has been revised, and it will now also apply to manufacturing and sales businesses. became.
The licensing requirements for manufacturing and sales of medical devices, etc. have been reviewed, and compliance with the QMS system ministerial ordinance is now one of the requirements, replacing the GQP ministerial ordinance.
In addition, in order to investigate the entire quality control and supervision system related to products as one, the surveys previously conducted by prefectures have been abolished, and the surveys will now be conducted by the PMDA for approved items and by registered certification bodies for certified items. Masu.
However, in principle, prefectures will continue to conduct on-site inspections to confirm the status of manufacturing control and quality control of medical devices, etc.
Structure of the quality control supervision system standards (quality manual)
QMS (Quality Management System) consists of quality management and supervision system standards and top (level 1 documents), including procedure manuals, regulations, work manuals, and records.
Clauses required to be documented by QMS Ministerial Ordinance
| clause | QMS ministerial ordinance |
| Statement of quality policy | Article 6, Paragraph 1, Item 1 |
| Statement of quality goals | Article 6, Paragraph 1, Item 1 |
| Quality control supervision system standards | Article 6, Paragraph 1 |
| Documents that define procedures | Article 6, Paragraph 1, Item 4 |
| Matters required to be documented according to the provisions of laws and regulations regarding pharmaceutical affairs | Article 6, Paragraph 1, Item 5 |
| Product standards | Article 6, Paragraph 2 |
| Responsibility and authority of departments and members engaged in work | Article 15, Paragraph 1 |
| Requirements related to maintenance of business operation infrastructure | Article 24, Paragraph 2 |
| Requirements regarding the health status of members, degree of cleanliness, etc. | Article 25, Paragraph 2 |
| Requirements regarding working environment conditions | Article 25, Paragraph 3 |
| Implementation guidelines for managing contaminated products, etc. | Article 25, Paragraph 5 |
| Requirements related to product risk management | Article 26, Paragraph 5 |
| Documents related to product requirements | Article 28 Paragraph 2 |
| Documents related to design and development plans | Article 30, Paragraph 5 |
| Document containing purchasing information | Article 38 Paragraph 3 |
| Requirements for manufacturing and service provision | Article 40, Paragraph 1 |
| Work instructions related to manufacturing and service provision | Article 40, Paragraph 1 |
| Product cleanliness requirements | Article 41 |
| Requirements related to installation work | Article 42, Paragraph 1 |
| System related to work instructions related to implementation of ancillary service operations, etc. | Article 43 Paragraph 1 |
| System related to work instructions related to product retention | Article 52, paragraph 1 |
| System for work instructions related to the management of products with limited expiration dates | Article 52 Paragraph 2 |
| Procedures for remanufacturing | Article 60, Paragraph 9 |
| Adverse effects of remanufacturing | Article 60, Paragraph 10 |
| Notice | Article 62, paragraph 2 |
| Documented quality control oversight system | Article 66 |
| To have all facilities and related registered manufacturing facilities notify the marketing authorization holder, etc. of the matters listed in Article 228-20, Paragraph XNUMX of the Enforcement Regulations when the facilities, etc. become aware of the matters listed in each item of Article XNUMX-XNUMX, Paragraph XNUMX of the Enforcement Regulations regarding the product. steps | Section 69 |
| Document specifying the duties of the domestic quality operations manager | Article 72 Paragraph 2 |
| Arrangements between manufacturers and related facilities and registered manufacturing sites | Article 72-2 |
| Instructions for handling notifications from repair companies | Article 72-2 paragraph 2 item 1 |
| Procedures for ensuring quality at distributors or lenders | Article 72-2 paragraph 2 item 2 |
| Procedures for processing notifications from second-hand sellers or lenders | Article 72-2 paragraph 2 item 3 |
Clauses required to be written as procedures by QMS ministerial ordinance
| clause | Procedure document example | QMS ministerial ordinance |
| Document management | Document management regulations | Article 8, Paragraph 2 |
| Control of records | Record management regulations | Article 9, Paragraph 2 |
| Work environment | Article 25, Paragraph 3 | |
| Product design and development | Article 30, Paragraph 1 | |
| Purchasing process | Purchasing management regulations | Article 37 Paragraph 1 |
| Manufacture and service provision management | Article 40, Paragraph 1 | |
| Ancillary service operations | Article 45, Paragraph 4 | |
| Sterilization process validation | Article 46 Paragraph 1 | |
| Product identification | Product identification management regulations | Article 47 Paragraph 2 |
| Identification of returned products | Product identification management regulations | Article 47 Paragraph 3 |
| Ensuring traceability | Product identification management regulations | Article 48 Paragraph 1 |
| product retention | Product storage regulations | Article 52, paragraph 1 |
| Management of products with limited expiration dates | Product storage regulations | Article 52 Paragraph 2 |
| monitoring and measurement | Article 53 Paragraph 2 | |
| Collecting opinions from product recipients, etc. | Regulations for collecting opinions from product recipients | Article 55, Paragraph 3 |
| Formulation and implementation of internal audit implementation plan, etc. | internal audit regulations | Article 56, paragraph 6 |
| Management, etc. related to processing of non-conforming products | Regulations for handling nonconforming products | Article 60, Paragraph 2 |
| Data analysis, etc. | Data analysis regulations | Article 61 Paragraph 1 |
| Issuance and implementation of notifications | Issuance of notice and implementation regulations | Article 62, paragraph 2 |
| Reporting defects, etc. to the Minister of Health, Labor and Welfare | Quality information, defect reports, recall management regulations | Article 62, paragraph 6 |
| Corrective action | Corrective and preventive action provisions | Article 63 Paragraph 2 |
| precautionary measures | Corrective and preventive action provisions | Article 64 Paragraph 2 |
Articles required to be recorded by QMS Ministerial Ordinance
| clause | Recording example | QMS ministerial ordinance |
| Management supervisor review results | Management review record | Article 18 Paragraph 2 |
| Training, skills and experience of members | Skill map, skill/education records | Article 23 item 5 |
| Maintenance work for business operation infrastructure | Article 24, Paragraph 4 | |
| Risk management | Risk analysis report, risk management implementation confirmation sheet | Article 26, Paragraph 6 |
| Results of verification of product requirements and measures taken based on the results | Article 28 Paragraph 3 | |
| Process input information related to design and development | Article 31 Paragraph 1 | |
| Process output information related to design and development | Article 32, Paragraph 4 | |
| Results of design and development review, etc. | Article 33, Paragraph 3 | |
| Results of design and development verification and measures taken based on the results | Article 34, Paragraph 2 | |
| Results of design development validation, etc. | Article 35, Paragraph 3 | |
| Results of review of changes in design and development, etc. | Article 36 Paragraph 4 | |
| Results of evaluation of suppliers of purchased goods, etc. | Supplier selection form, supplier annual evaluation sheet | Article 37, Paragraph 5 |
| Purchasing information | Purchasing information | Article 38 Paragraph 3 |
| Verification of purchased items | Purchased product acceptance inspection slip | Article 39, Paragraph 3 |
| Records for each lot of product | Article 40, Paragraph 2 | |
| Installation and verification of medical equipment | Article 42, paragraph 3 | |
| Ancillary services performed | Maintenance/repair work records, incidental service work instructions | Article 43 Paragraph 2 |
| Process index values for each sterilized lot | Article 44 Paragraph 1 | |
| Validation of manufacturing processes, etc. | Article 45, Paragraph 6 | |
| Sterilization process validation results | Article 46 Paragraph 3 | |
| Identification for traceability | Article 48 Paragraph 3 | |
| Name and address of consignee of products related to specified medical devices | Article 49, Paragraph 4 | |
| Details of loss, damage, etc. of goods etc. by the product recipient | Product recipient supplies management table | Article 51 Paragraph 2 |
| special storage conditions | Product storage condition management table | Article 52, Paragraph 3 |
| Calibration or verification in the absence of metrological standards | Article 53 Paragraph 3 Item 1 | |
| Evaluation of the validity of previous monitoring and measurement results | Article 53, Paragraph 6 | |
| Results of calibration and verification of equipment and instruments for monitoring and measurement | Article 49, Paragraph 4 | |
| Internal audit results | Internal audit plan and notification, internal audit checklist, internal audit report/corrective action request, internal audit corrective action report | Article 56, paragraph 6 |
| Product monitoring and measurement results | Article 58 Paragraph 3 | |
| The person who made the decision on whether or not to ship | Article 58 Paragraph 4 | |
| Members who conducted testing and inspection work for products related to specified medical devices | 59th | |
| Members who authorized special adoption of nonconforming products | Non-conforming product disposition form | Article 60, Paragraph 5 |
| Contents of nonconformity, etc. | Non-conforming product disposition form | Article 60, Paragraph 6 |
| Results of data analysis | Data analysis record | Article 61, paragraph 3 |
| Investigation of product recipient complaints | complaint record | Article 62, paragraph 3 |
| Reasons for not taking corrective or preventive action | complaint record | Article 62, paragraph 5 |
| Investigation results regarding corrective measures, etc. | Corrective and preventive action record | Article 63 item 5 |
| Survey results regarding preventive measures, etc. | Corrective and preventive action record | Article 64 Paragraph 2 |
| A copy of a document stating the necessary opinion to the marketing authorization holder, supervisor, or other person responsible for the relevant work. | Opinion written by the chief engineer | Article 71 Paragraph 1 Item 2 |
| For products to be distributed domestically, the results of determining whether to ship to the market for each lot and records of shipment to the market such as shipping destination | Record of shipment to market | Article 72 Paragraph 2 Item 3 |
| A document that reports to the management manager and the general marketing and marketing manager for medical devices, etc. when there is a risk of a significant impact on the quality of the product due to a change in the manufacturing method, etc. of a product distributed domestically. | Domestic quality operations manager report | Article 72 Paragraph 2 Item 4 |
| When obtaining information regarding the quality of a product distributed domestically (including information regarding quality defects or the risk of quality defects), report to the management supervisor and the general marketing and marketing manager for medical devices, etc. record | Domestic quality operations manager report | Article 72 Paragraph 2 Item 5 |
| Records describing the details of the recall of products distributed domestically, and records of reports of such records to the management manager and the general marketing and marketing manager for medical devices, etc. | Recovery record | Article 72, Paragraph 2, Item 6 (b) |
| In addition to what is listed in Article 72, Paragraph 2, Items 3 to 6, reporting to the Manager and the General Marketing and Marketing Manager for Medical Devices, etc. when deemed necessary for the performance of domestic quality control operations. document | Domestic quality operations manager report | Article 72 Paragraph 2 Item 7 |
| In carrying out domestic quality control operations, as necessary, to manufacturers of related registered manufacturing facilities, foreign manufacturers of medical devices, distributors, pharmacy establishments, hospital and clinic establishments, and other related parties. Documentation of communications or instructions carried out; | Instructions for manufacturers, distributors, users, etc. | Article 72 Paragraph 2 Item 8 |
| A document reporting information regarding safety measures stipulated in Article 2, Paragraph 2 of the GVP Ministerial Ordinance to the safety management department (department related to the control of safety operations) | Report to safety management department | Article 72 Paragraph 2 Item 9 |
| Records regarding the decision on whether or not to ship to the market made by a person designated in advance by the Domestic Quality Operations Manager, and documents reporting such records to the Domestic Quality Operations Operations Manager. | Market release judgment report | Article 72, paragraph 4 |
Related notice
| Issue date | Document number | notification name |
| August 26, 27 | Pharmaceutical, Food and Drug Administration Bulletin 0827 No. XNUMX | Regarding the revision of the ministerial ordinance regarding manufacturing control and quality control standards for medical devices and in vitro diagnostic drugs in accordance with the enforcement of the law partially amending the Pharmaceutical Affairs Law, etc. |
| 26th, April 11 | 1119 No. 1119 from the Pharmaceutical Food and Food Administration Department, XNUMX No. XNUMX from the Pharmaceutical Food and Food Administration Department | Regarding the handling of standards conformity certificate and QMS conformity investigation application |
| 26th, April 10 | Pharmaceutical Food and Drug Administration Bulletin 1024 No. 10 | Regarding the establishment of QMS investigation guidelines |
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.
We provide legal services related to medical devices based on the know-how and track record that we can accumulate because we are administrative scriveners who handle applications and negotiations with administrative agencies on behalf of companies on a daily basis.
Our staff has a track record of applying in all prefectures across the country. Please contact us by all means.
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