Legal, Regulatory and Licensing Risks in Each Country
First written in FY2016. 25 of 27 entries say "Restated". Latest entry: FY2025.
The whole theme swung hardest in 2020: 2 of 6 companies on the "Worse" side.
5 other companies' latest entry also says "Restated".
- FY2025RestatedAnnual report
「Regulations in each country are tending to become more stringent, and the Group is working to strengthen the capabilities of its regulatory affairs department in handling various regulatory approvals. However, if the Group is unable to obtain approvals in the countries where its products are sold, if approvals already obtained are revoked, or if approvals are not obtained in a timely manner, business plans may be delayed or revised, potentially affecting the Group's performance.」
The trend toward tighter regulations in each country, the risks of failure to obtain, revocation or delays in obtaining regulatory approvals, and the response by the regulatory affairs department continue to be described. - FY2024-Q3RestatedAnnual report
「During the cumulative third quarter of the current consolidated fiscal year, there were no new business or other risks, nor any material changes to the business and other risks described in the annual securities report for the previous fiscal year.」
Legal and regulatory approval risks in each country have been reconfirmed through a comprehensive statement that there have been no new developments or material changes. - FY2024-Q1RestatedAnnual report
「During the cumulative first quarter under review, there were no new business or other risks, nor any material changes to the business or other risks described in the annual securities report for the previous fiscal year.」
Legal and regulatory approval risks in each country have been reconfirmed through a comprehensive statement that there have been no new developments or material changes. - FY2023-Q2RestatedAnnual report
「During the cumulative second quarter of the current consolidated fiscal year, there were no new business or other risks, nor any material changes to the business and other risks described in the annual securities report for the previous fiscal year.」
Legal and regulatory approval risks in each country have been reconfirmed through a comprehensive statement that there have been no new developments or material changes. - FY2023-Q1RestatedAnnual report
「During the cumulative first quarter under review, there were no new business or other risks, nor any material changes to the business or other risks described in the annual securities report for the previous fiscal year.」
Legal and regulatory approval risks in each country have been reconfirmed through a comprehensive statement that there have been no new developments or material changes. - FY2022RestatedAnnual report
「Regulations in each country are tending to become more stringent, and the Group is working to strengthen the capabilities of its regulatory affairs department in handling various regulatory approvals. However, if the Group is unable to obtain approvals in the countries where its products are sold, if approvals already obtained are revoked, or if approvals are not obtained in a timely manner, business plans may be delayed or revised, potentially affecting the Group's performance.」
The trend toward tighter regulations, the risk of delays to business plans resulting from failure to obtain, revocation or delays in obtaining regulatory approvals, and the response by the regulatory affairs department continue to be described. - FY2022-Q3RestatedAnnual report
「During the cumulative third quarter of the current consolidated fiscal year, there were no new business or other risks, nor any material changes to the business and other risks described in the annual securities report for the previous fiscal year.」
Legal and regulatory approval risks in each country have been reconfirmed through a comprehensive statement that there have been no material changes. - FY2022-Q2RestatedAnnual report
「During the cumulative second quarter of the current consolidated fiscal year, there were no new business or other risks, nor any material changes to the business and other risks described in the annual securities report for the previous fiscal year.」
Legal and regulatory approval risks in each country have been reconfirmed through a comprehensive statement that there have been no material changes. - FY2022-Q1RestatedAnnual report
「During the cumulative first quarter under review, there were no new business or other risks, nor any material changes to the business or other risks described in the annual securities report for the previous fiscal year.」
Legal and regulatory approval risks in each country have been reconfirmed through a comprehensive statement that there have been no material changes. - FY2021RestatedAnnual report
「Regulations in each country are tending to become more stringent, and the Group is working to strengthen the capabilities of its regulatory affairs department in handling various regulatory approvals. However, if the Group is unable to obtain approvals in the countries where its products are sold, if approvals already obtained are revoked, or if approvals are not obtained in a timely manner, business plans may be delayed or revised, potentially affecting the Group's performance.」
The trend toward tighter regulations, the risk of delays to business plans resulting from delays in or revocation of regulatory approvals, and the response by the regulatory affairs department continue to be described. - FY2021-Q3RestatedAnnual report
「During the cumulative third quarter of the current consolidated fiscal year, there were no new business or other risks, nor any material changes to the business and other risks described in the annual securities report for the previous fiscal year.」
Legal and regulatory approval risks in each country have been reconfirmed through a comprehensive statement that there have been no material changes. - FY2021-Q2RestatedAnnual report
「During the cumulative second quarter of the current consolidated fiscal year, there were no new business or other risks, nor any material changes to the business and other risks described in the annual securities report for the previous fiscal year.」
Legal and regulatory approval risks in each country have been reconfirmed through a comprehensive statement that there have been no material changes. - FY2020WorsenedAnnual report
「Regulations in each country are tending to become more stringent, and the Group is working to strengthen the capabilities of its regulatory affairs department in handling various regulatory approvals. However, if the Group is unable to obtain approvals in the countries where its products are sold, if approvals already obtained are revoked, or if approvals are not obtained in a timely manner, business plans may be delayed or revised, potentially affecting the Group's performance.」
It has newly been stated explicitly that regulations in each country are tending to become more stringent and that delays in obtaining regulatory approvals could result in delays to or revisions of business plans. - FY2020-Q3RestatedAnnual report
「During the cumulative third quarter of the current consolidated fiscal year, there were no new business or other risks, nor any material changes to the business and other risks described in the annual securities report for the previous fiscal year.」
Legal and regulatory approval risks in each country have been reconfirmed through a comprehensive statement that there have been no new developments or material changes. - FY2020-Q2RestatedAnnual report
「During the cumulative second quarter of the current consolidated fiscal year, there were no new business or other risks, nor any material changes to the business and other risks described in the annual securities report for the previous fiscal year.」
Legal and regulatory approval risks in each country have been reconfirmed through a comprehensive statement that there have been no new developments or material changes. - FY2020-Q1RestatedAnnual report
「During the cumulative first quarter under review, there were no new business or other risks, nor any material changes to the business or other risks described in the annual securities report for the previous fiscal year.」
Legal and regulatory approval risks in each country have been reconfirmed through a comprehensive statement that there have been no new developments or material changes. - FY2019-Q3RestatedAnnual report
「During the cumulative third quarter of the current consolidated fiscal year, there were no new business or other risks, nor any material changes to the business and other risks described in the annual securities report for the previous fiscal year.」
Legal and regulatory approval risks in each country have been reconfirmed through a comprehensive statement that there have been no new developments or material changes. - FY2019-Q2RestatedAnnual report
「During the cumulative second quarter of the current consolidated fiscal year, there were no new business or other risks, nor any material changes to the business and other risks described in the annual securities report for the previous fiscal year.」
Legal and regulatory approval risks in each country have been reconfirmed through a comprehensive statement that there have been no new developments or material changes. - FY2019-Q1RestatedAnnual report
「During the cumulative first quarter under review, there were no new business or other risks, nor any material changes to the business or other risks described in the annual securities report for the previous fiscal year.」
Legal and regulatory approval risks in each country have been reconfirmed through a comprehensive statement that there have been no new developments or material changes. - FY2018RestatedAnnual report
「The development, manufacture and sale of medical devices by the Group are subject to the laws and regulations of the countries where the products are sold. If the Group is unable to obtain regulatory approvals in those countries, or if approvals already obtained are revoked, the Group's performance may be affected.」
Legal and regulatory approval risks in each country associated with overseas expansion continue to be disclosed. - FY2018-Q3RestatedAnnual report
「During the cumulative third quarter of the current consolidated fiscal year, there were no new business or other risks, nor any material changes to the business and other risks described in the annual securities report for the previous fiscal year.」
Legal and regulatory approval risks in each country have been reconfirmed through a comprehensive statement that there have been no new developments or material changes. - FY2018-Q2RestatedAnnual report
「During the cumulative second quarter of the current consolidated fiscal year, there were no new business or other risks, nor any material changes to the business and other risks described in the annual securities report for the previous fiscal year.」
Legal and regulatory approval risks in each country have been reconfirmed through a comprehensive statement that there have been no new developments or material changes. - FY2018-Q1RestatedAnnual report
「During the cumulative first quarter under review, there were no new business or other risks, nor any material changes to the business or other risks described in the annual securities report for the previous fiscal year.」
Legal and regulatory approval risks in each country have been reconfirmed through a comprehensive statement that there have been no new developments or material changes. - FY2017-Q3RestatedAnnual report
「During the cumulative third quarter of the current consolidated fiscal year, there were no new business or other risks, nor any material changes to the business and other risks described in the annual securities report for the previous fiscal year.」
Legal and regulatory approval risks in each country have been reconfirmed through a comprehensive statement that there have been no material changes. - FY2017-Q2RestatedAnnual report
「During the cumulative second quarter of the current consolidated fiscal year, there were no new business or other risks, nor any material changes to the business and other risks described in the annual securities report for the previous fiscal year.」
Legal and regulatory approval risks in each country have been reconfirmed through a comprehensive statement that there have been no material changes. - FY2017-Q1RestatedAnnual report
「During the cumulative first quarter under review, there were no new business or other risks, nor any material changes to the business or other risks described in the annual securities report for the previous fiscal year.」
Legal and regulatory approval risks in each country have been reconfirmed through a comprehensive statement that there have been no material changes. - FY2016First statedAnnual report
「The development, manufacture and sale of medical devices by the Group are subject to the laws and regulations of the countries where the products are sold. If the Group is unable to obtain regulatory approvals in those countries, or if approvals already obtained are revoked, the Group's performance may be affected.」
Obtaining and maintaining regulatory approvals in each country in connection with overseas expansion is identified as a risk.