Examples of indications from various administrative agencies regarding medical device licensing

Updated: July 2024, 3

Examples pointed out by PMDA

management supervision

・The scope of the quality control supervision system was not described.

- It was not made clear what kind of abilities were required for those engaged in work that affected product quality.

- It was not possible to confirm that the effectiveness of the measures was evaluated in education and training.

- Judgment criteria for internal audits were not established.

- Internal auditors audited their own operations, and objectivity and fairness could not be ensured.

・During internal audits, only some departments within the scope of QMS were audited.

・In the internal audit, it could not be confirmed that the provisions of the QMS Ministerial Ordinance were covered.

design management

・The design and development plan was not updated appropriately in accordance with changes in design and development.

・Records of design changes could not be confirmed.

・Although the procedure manual stipulated that experts related to design and development must participate in the design and development review, it could not be confirmed that they participated.

・In the design verification record, the dimensional measurement results of the test samples deviated from the tolerances of the shape drawing specified in the approval application form, but the design development verification was approved without any valid reason.

product documentation

・There were products manufactured and sold for which product standards had not been created.

・Requirements related to risk management were not documented.

・The procedure was to obtain the manufacturer's risk management report, examine it, and create records, but the relevant records were not created.

・Risk management was not implemented for some processes related to product realization. Furthermore, no records were kept of the results of the implementation.

製造

- Necessary calibration was not performed to ensure the validity of monitoring and measurement results.

・Products with limited expiration dates or products that require special storage conditions were not stored under appropriate management.

・Methods for identifying and managing nonconforming products were not documented.

・Records of the details of nonconformity and the measures taken against nonconformity were not kept.

・Validation was not implemented in a process where it was considered that the output information related to the process results could not be verified through subsequent monitoring or measurement, and no valid reason could be found for not implementing it.

・The development, validation, and daily operations of the sterilization process for sterilized medical devices were not conducted in accordance with sterilization validation standards.

Corrective and preventive measures

- Records of data analysis conducted to demonstrate the effectiveness of the quality control and supervision system were not created.

・Regarding corrective measures, the effectiveness of the measures taken was not checked.

・Process nonconformity was not included in the scope of corrective action.

・The cause of nonconformity was not identified.

・Regarding corrective measures, it was not possible to confirm the records of the results of the measures taken.

Purchasing Management

・The service to be purchased is not considered in the scope of application.

・Judgment criteria for supplier selection, evaluation, and re-evaluation are not clear.

・It is not possible to confirm that necessary tests, inspections, and other verification work are being carried out to ensure that purchased goods comply with the requirements for purchased goods.

・It is not possible to confirm that the purchased items conform to the requirements for purchased items.

Manufacturers, distributors, etc.

・When determining whether or not to release the product to the market, no records were created regarding the evaluation of information regarding quality, efficacy, and safety.

・Collect information from Japan and abroad regarding changes in manufacturing methods, testing and inspection methods, etc. that may affect product quality, report in writing to the management manager and the general marketing and marketing manager, and take necessary and appropriate measures. That was not documented.

Examples pointed out by the Tokyo Metropolitan Government

・When collecting safety measures, the targets of academic and literature information collection are not clear.

- If there is no information that corresponds to safety management information as a result of researching academic conferences, literature information, etc., this fact is not recorded.

・Records of the safety management officer's involvement and evaluation of the collected information have not been created.

・We are conducting a survey regarding the safety management information we have collected, but we are not able to manage the progress.

- Safety management information was being considered, but no records had been created.

・The safety management manager did not report the proposed safety measures in writing to the general marketing and marketing manager.

・Appropriate progress management according to the type of measure was not possible. (Not in time for 15th and 30th reporting.)

・In the case of revision of package inserts, there was no communication document to the quality assurance department (person in charge of domestic quality operations).

・The results of implementing safety measures were not reported in writing to the general marketing and marketing manager.

Examples pointed out by Osaka Prefecture

・Product standards based on ministerial ordinances were not prepared for all manufactured and sold items.

- Regarding document management, there were discrepancies with the actual situation regarding the handling of obsolete documents, and procedures were not in line with the actual situation.

・Regarding record management, procedures for protecting records were not created.

・Regarding the determination of release to the market, there was no record of the determination of release to the market based on the ministerial ordinance.

・Regarding the recall process, procedures and record formats were not stipulated for reporting to the management supervisor and the general marketing and sales manager for medical devices, etc., based on the ministerial ordinance.

- Regarding quality information processing, there was a discrepancy between the actual situation and the procedure manual, and appropriate procedures in accordance with the ministerial ordinance and the actual situation were not specified.