Examples of reforms submitted to each administrative organization for medical equipment approval

Updated: July 2024, 3

Example of revision submitted by PMDA

management director

・Systematic implementation of product quality management.

・Insufficient personnel management skills for production, production, and quality work.

・No legal confirmation of the effectiveness of educational training.

・Internal analytical judgment standard.

・Internal review staff, independent review, lawless security and impartiality.

・While conducting internal research, we have determined that a certain part of the QMS application program has completed its progress.

・While we are conducting internal research, we are not sure whether or not the QMS ministerial regulations have been determined.

design management

・Local update design and development plan will be changed based on the existing design and development plan.

・Record of changes to the confirmation.

・Evaluation of the basic operating procedures, design and development procedures must be attended by the family advisor, but without legal confirmation, the family advisor may be included.

・During the design review, the actual dimensions of the test product may exceed the tolerances of the shape and size during the review, however, under reasonable circumstances, the test results may still be subject to review.

Product writing

・Manufactured goods with non-existent manufacturing goods.

・Requirements for wind and wind management consultations have been written down.

・The construction was completed, the production and commercial wind management report was reported, and the operation process was recorded in parallel, but it was not yet constructed.

・Management of certain minor engineering procedures and trends in the production of unused goods and products. This is a record of the construction results.

Manufacturing

・Required proofreading to ensure the validity of the results.

・Products may be stored under certain conditions, with limited expiration date, or with special demand.

・Creation of management method for identification of missing items, non-conformities, and requirements.

・A record of the actions taken to take the content of the non-conformity requirements and the contents of the non-conformity requirements.

・During the process, there are valid reasons for not confirming that there is no actual use of the product, and no valid reason for not proceeding.

・Unavailable for testing and testing of germs, medical instruments, and procedures for disinfection, daily operations.

Enforcement of security measures, enforcement of safety measures

・An analytical record of the effectiveness and progress of the quality control system.

・We will take corrective measures to ensure the effectiveness of the corrective measures taken in place of lost property.

・Illustration of request for non-compliance with the lost process and corrective measures taken.

・Unconfirmed cause of discrepancy.

・A record of the results of the corrective measures taken and the corrective measures taken at the illegal confirmation site.

Purchase management

・Comprehensive service for those who wish to purchase.

・Confirmation of commercial selection, review and new selection criteria.

・Unauthorized confirmation of necessary inspections and other verification work may be required to ensure that the purchased goods match the purchased goods requirements.

・Confirm whether the purchased goods are correct or not and match the requirements for the purchased goods.

Manufacturing companies, etc.

・Record of information regarding the progress of information regarding the quality, effectiveness, safety, and safety at the time of sale at the market.

・Information on changes in production methods, testing methods, etc., which have not yet been collected domestically and internationally, the person responsible for managing the paper report, the person responsible for the production of the product, and the necessary appropriate measures to be taken, etc. .

Example of reform submitted by East Kyoto

・Collection of current situation when security measures are in place, information collected from unknown academic Japanese literature.

・Information on the Japanese literature of the Japanese academic conference, information on the safety management information that may result in loss, and records of the progress of the current situation.

・Record of information collected by the consultant responsible for building safety management of unused buildings.

・Accurately, the collective safety management information is mutually controlled, but the management is free of law.

・Please note that the safety management information was not followed, but it was not recorded.

・Implement safety assurance measures such as drafting a report for the person responsible for safety management.

・Adequate progress management based on non-legal and fundamental measures. (Completed within the reporting period of 15 days and 30 days.)

・Contact letter for sending documents related to revisions, etc., to the product quality assurance department (domestic product quality assurance department).

・The results of the implementation of safety and certification measures will be reported in the written record of the person responsible for the production of the undirected product.

Example of reform submitted by Osaka Prefecture

- Copying of non-proprietary manufactured goods and articles according to the ministerial regulations.

・In terms of the management of existing documents, the procedures and actual circumstances of the documents being removed, the actual circumstances that may be out of order.

・Procedure for the management of the record and the protection of the record.

・Records of market-based sales judgments, missing basic U.S. ministerial ordinances, and records of market-based sales judgments for construction and construction.

・In the area of ​​current management, the person responsible for the management of medical equipment, medical equipment, etc. in the direction of management, reporting the progress of the person responsible for the production of medical equipment, etc., and reporting the progress of the correspondence process order and record.

・In terms of quality information processing, there are differences in the operating procedures given the actual circumstances, and the applicable procedures for the laws and regulations have not been determined.