Renewal and Acquisition of Licenses and Approvals for the Marketing of Medical Devices
First written in FY2016. 13 of 17 entries say "Restated". Latest entry: FY2025-H1.
The whole theme swung hardest in 2018: 1 of 7 companies on the "Worse" side.
7 other companies' latest entry also says "Restated".
- FY2025-H1RestatedAnnual report
「No new business or other risks arose during the current interim consolidated accounting period. In addition, there were no material changes to the business and other risks described in the securities report for the previous fiscal year.」
The company disclosed that there had been no material changes regarding the risks associated with renewing and obtaining manufacturing and marketing licenses and approvals. - FY2024-Q3RestatedAnnual report
「No new business or other risks arose during the cumulative third quarter of the current consolidated fiscal year. There were also no material changes to the business and other risks described in the securities report for the previous fiscal year.」
The company disclosed that there had been no material changes regarding the risks associated with renewing and obtaining manufacturing and marketing licenses and approvals. - FY2022MitigatedAnnual report
「Class I Medical Device Manufacturing and Marketing License Certificate License for Class I Medical Device Manufacturing and Marketing License No.: 13B1X00007 30 June 2027 (renewed every 5 years)」
The validity period of the Class I medical device manufacturing and marketing license was stated as ending on 30 June 2027, confirming the continuation of the license and approvals. - FY2021-Q2RestatedAnnual report
「No new business or other risks arose during the six-month period ended [the second quarter]. There were also no material changes to the business and other risks described in the annual securities report for the previous fiscal year.」
The company disclosed that there had been no material changes regarding the risks associated with renewing and obtaining manufacturing and marketing licenses and approvals. - FY2020-Q3RestatedAnnual report
「No new business or other risks arose during the cumulative third quarter of the current consolidated fiscal year. There were also no material changes to the business and other risks described in the securities report for the previous fiscal year.」
The company disclosed that there had been no material changes regarding the risks associated with renewing and obtaining manufacturing and marketing licenses and approvals. - FY2020-Q2RestatedAnnual report
「No new business or other risks arose during the six-month period ended [the second quarter]. There were also no material changes to the business and other risks described in the annual securities report for the previous fiscal year.」
The company disclosed that there had been no material changes regarding the risks associated with renewing and obtaining manufacturing and marketing licenses and approvals. - FY2020-Q1RestatedAnnual report
「No new business or other risks arose during the three-month period ended [the first quarter]. There were also no material changes to the business and other risks described in the annual securities report for the previous fiscal year.」
The company disclosed that there had been no material changes regarding the risks associated with renewing and obtaining manufacturing and marketing licenses and approvals. - FY2019WorsenedAnnual report
「If approval for the medical device cannot be obtained, or if the period required to obtain approval becomes longer than expected, the group may need to change its sales strategy, which could affect its operating results and financial position.」
The company specified as risks not only the revocation or inability to renew licenses and approvals, but also the possibility of changing its sales strategy if obtaining approval is delayed. The validity period of the Class I medical device manufacturing and marketing license was stated as ending on 30 June 2022. - FY2019-Q3RestatedAnnual report
「No new business or other risks arose during the cumulative third quarter of the current consolidated fiscal year. There were also no material changes to the business and other risks described in the securities report for the previous fiscal year.」
The company disclosed that there had been no material changes regarding the risks associated with renewing and obtaining manufacturing and marketing licenses and approvals. - FY2018RestatedAnnual report
「If the manufacturing and marketing license described above cannot be renewed or is revoked, or if approval for a medical device cannot be obtained or is revoked, this may affect our group’s operating results and financial position.」
The company reiterated the regulatory and approval risks, stating that the Class I medical device manufacturing and marketing license was valid until 30 June 2022 and required renewal every 5 years. - FY2018-Q3RestatedAnnual report
「No new business or other risks arose during the cumulative third quarter of the current consolidated fiscal year. There were also no material changes to the business and other risks described in the securities report for the previous fiscal year.」
The risks associated with renewing and obtaining manufacturing and marketing licenses and approvals were treated as having undergone no material changes. - FY2018-Q1RestatedAnnual report
「No new business or other risks arose during the three-month period ended [the first quarter]. There were also no material changes to the business and other risks described in the annual securities report for the previous fiscal year.」
The company disclosed that there had been no material changes regarding the risks associated with renewing and obtaining manufacturing and marketing licenses and approvals. - FY2017MitigatedAnnual report
「Class I Medical Device Manufacturing and Marketing License Certificate License for Class I Medical Device Manufacturing and Marketing License No.: 13B1X00007 30 June 2022 (renewed every 5 years)」
The validity period of the manufacturing and marketing license was stated as ending on 30 June 2022, indicating that the license would continue beyond the previous renewal deadline. - FY2017-Q3RestatedAnnual report
「No new business or other risks arose during the cumulative third quarter of the current consolidated fiscal year. There were also no material changes to the business and other risks described in the securities report for the previous fiscal year.」
The risks associated with renewing and obtaining manufacturing and marketing licenses and approvals were treated as having undergone no material changes. - FY2017-Q2RestatedAnnual report
「No new business or other risks arose during the six-month period ended [the second quarter]. There were also no material changes to the business and other risks described in the annual securities report for the previous fiscal year.」
The risks associated with renewing and obtaining manufacturing and marketing licenses and approvals were treated as having undergone no material changes. - FY2017-Q1RestatedAnnual report
「No new business or other risks arose during the three-month period ended [the first quarter]. There were also no material changes to the business and other risks described in the annual securities report for the previous fiscal year.」
The company disclosed that there had been no material changes regarding the risks associated with renewing and obtaining manufacturing and marketing licenses and approvals. - FY2016First statedAnnual report
「If the manufacturing and marketing license described above cannot be renewed or is revoked, or if approval for a medical device cannot be obtained or is revoked, this may affect our group’s operating results and financial position.」
The validity period of the Class I medical device manufacturing and marketing license was stated as ending on 30 June 2017, with renewal required every 5 years.