Licensing and Permit Risks Relating to the Sale of Medical Devices, Pharmaceuticals and Welfare Equipment
First written in FY2016. 11 of 13 entries say "Restated". Latest entry: FY2024.
The whole theme swung hardest in 2026: 4 of 7 companies on the "Worse" side.
9 other companies' latest entry also says "Restated".
- FY2024RestatedAnnual report
「The sale, rental, repair, and manufacture and sale of medical devices, as well as the sale of pharmaceuticals and regenerative medicine products, are subject to regulation under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices. Other businesses conducted by the Group and the products and services it handles are subject to various industry-specific laws, including the Poisonous and Deleterious Substances Control Act, the Long-Term Care Insurance Act, and the Construction Business Act, as applicable.」
Continues to cite licensing, permit, and legal regulatory risks relating to medical devices, pharmaceuticals, regenerative medicine products, welfare equipment, and the construction business, among others. - FY2022RestatedAnnual report
「The sale, rental, repair, and manufacture and sale of medical devices, as well as the sale of pharmaceuticals and regenerative medicine products, are subject to regulation under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices. Other businesses conducted by the Group and the products and services it handles are subject to various industry-specific laws, including the Poisonous and Deleterious Substances Control Act, the Long-Term Care Insurance Act, and the Construction Business Act, as applicable.」
Continues to cite licensing, permit, and legal regulatory risks relating to medical devices, pharmaceuticals, regenerative medicine products, welfare equipment, and the construction business, among others. - FY2020RestatedAnnual report
「The sale, rental, repair, and manufacture and sale of medical devices, as well as the sale of pharmaceuticals and regenerative medicine products, are subject to regulation under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices. Other businesses conducted by the Group and the products and services it handles are subject to various industry-specific laws, including the Poisonous and Deleterious Substances Control Act, the Long-Term Care Insurance Act, and the Construction Business Act, as applicable.」
Continues to cite licensing, permit, and legal regulatory risks relating to medical devices, pharmaceuticals, regenerative medicine products, welfare equipment, and the construction business, among others. - FY2020-Q3RestatedAnnual report
「In importing and selling medical devices and other products, our Group has established a manufacturing and quality control framework as required by ordinances of the Ministry of Health, Labour and Welfare, formulated post-market safety management procedures, and obtained permits from prefectural governors. However, as the range of products handled expands, product-related health damage or other incidents could occur, resulting in claims for damages and a decline in confidence.」
Continues to describe manufacturing and quality control, post-market safety management, and the risk of product-related health damage relating to medical devices and other products. - FY2020-Q2RestatedAnnual report
「In importing and selling medical devices and other products, our Group has established a manufacturing and quality control framework as required by ordinances of the Ministry of Health, Labour and Welfare, formulated post-market safety management procedures, and obtained permits from prefectural governors. However, as the range of products handled expands, product-related health damage or other incidents could occur, resulting in claims for damages and a decline in confidence.」
Continues the responses involving manufacturing and quality control and post-market safety management to licensing and permit risks relating to the manufacture and sale of medical devices and the risk of product-related health damage. - FY2020-Q1Added risks relating to the manufacture and sale of medical devices and product-related health damage.Annual report
「In importing and selling medical devices and other products, our Group has established a manufacturing and quality control framework as required by ordinances of the Ministry of Health, Labour and Welfare, formulated post-market safety management procedures, and obtained permits from prefectural governors. However, as the range of products handled expands, product-related health damage or other incidents could occur, resulting in claims for damages and a decline in confidence.」
Describes, in addition to the existing risk of revocation of sales licenses and permits, the possibility of product-related health damage, claims for damages, and a decline in confidence as the range of products handled expands. - FY2019RestatedAnnual report
「In selling the relevant products, our Group has appointed sales supervisors, introduced a traceability system to strengthen its safety management framework, and obtained permits from prefectural governors. However, if any act violating the applicable laws occurs for any reason, the permits for the sale and rental of highly controlled medical devices at the relevant business location may be revoked or otherwise sanctioned, which could cause fluctuations in our Group's sales and earnings.」
Continues the responses involving sales supervisors and the traceability system to the risk of revocation of licenses and permits relating to medical device sales. - FY2019-Q3RestatedAnnual report
「In selling the relevant products, our Group has appointed sales supervisors, introduced a traceability system to strengthen its safety management framework, and obtained permits from prefectural governors. However, if any act violating the applicable laws occurs for any reason, the permits for the sale and rental of highly controlled medical devices at the relevant business location may be revoked or otherwise sanctioned, which could cause fluctuations in our Group's sales and earnings.」
Continues to describe the risk of revocation of licenses and permits relating to medical device sales and the responses involving sales supervisors and the traceability system. - FY2019-Q2RestatedAnnual report
「In selling the relevant products, our Group has appointed sales supervisors, introduced a traceability system to strengthen its safety management framework, and obtained permits from prefectural governors. However, if any act violating the applicable laws occurs for any reason, the permits for the sale and rental of highly controlled medical devices at the relevant business location may be revoked or otherwise sanctioned, which could cause fluctuations in our Group's sales and earnings.」
Continues to describe the risk of revocation of licenses and permits relating to medical device sales and safety management through sales supervisors and the traceability system. - FY2019-Q1RestatedAnnual report
「In selling the relevant products, our Group has appointed sales supervisors, introduced a traceability system to strengthen its safety management framework, and obtained permits from prefectural governors. However, if any act violating the applicable laws occurs for any reason, the permits for the sale and rental of highly controlled medical devices at the relevant business location may be revoked or otherwise sanctioned, which could cause fluctuations in our Group's sales and earnings.」
Continues to describe licensing and permit risks relating to medical device sales and the responses involving sales supervisors and the traceability system. - FY2018RestatedAnnual report
「Our Group has appointed sales supervisors at all sales locations, introduced a traceability system to strengthen its safety management framework, and obtained permits from the governors of the relevant prefectures. However, if any act violating the applicable laws occurs for any reason, the permits for the sale and rental of highly controlled medical devices at the business locations of our consolidated subsidiaries may be revoked or otherwise sanctioned, which could cause fluctuations in our Group's sales and earnings.」
Describes the risk of revocation of licenses and permits relating to medical devices, pharmaceuticals, repairs, poisonous and deleterious substances, welfare equipment, and the construction business, as well as responses involving the appointment of responsible managers, quality control, and traceability. - FY2017RestatedAnnual report
「Our Group has appointed sales supervisors at all sales locations, introduced a traceability system to strengthen its safety management framework, and obtained permits from the governors of the relevant prefectures. However, if any act violating the applicable laws occurs for any reason, the permits for the sale and rental of highly controlled medical devices at the business locations of our consolidated subsidiaries may be revoked or otherwise sanctioned, which could cause fluctuations in our Group's sales and earnings.」
Describes the risk of revocation of licenses and permits relating to medical devices, pharmaceuticals, repairs, poisonous and deleterious substances, welfare equipment, and the construction business, as well as responses involving responsible managers and quality control. - FY2016First statedAnnual report
「Our Group has appointed sales supervisors at all sales locations, introduced a traceability system to strengthen its safety management framework, and obtained permits from the governors of the relevant prefectures. However, if any act violating the applicable laws occurs for any reason, the permits for the sale and rental of highly controlled medical devices at the business locations of our consolidated subsidiaries may be revoked or otherwise sanctioned, which could cause fluctuations in our Group's sales and earnings.」
States that the revocation of licenses and permits relating to medical device sales and repairs, pharmaceuticals, welfare equipment sales and rentals, and the construction business could affect sales and earnings.