Risk of Failing to Meet Medical Device Laws and Licensing Requirements
First written in FY2018. 2 of 4 entries say "Restated". Latest entry: FY2021.
The whole theme swung hardest in 2018: 1 of 7 companies on the "Worse" side.
2 other companies' latest entry also says "Mitigated".
- FY2021MitigatedAnnual report
「The group works closely with administrative departments and the relevant business locations to obtain and maintain the appropriate licenses and permits. It also provides regular training to all employees and works to ensure compliance with relevant laws and regulations.」
Coordination between administrative departments and business locations, the acquisition and maintenance of licenses and permits, and regular training for all employees were specified as countermeasures. - FY2020RestatedAnnual report
「If the Company ceases to meet requirements prescribed by the Act, including qualification requirements for the person responsible for sales, quality-control requirements and traceability requirements, such as maintaining sales records, the relevant license may be revoked.」
The risk of license revocation due to failure to meet qualification, quality control and traceability requirements under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices was reconfirmed. - FY2019RestatedAnnual report
「If the Company ceases to meet requirements prescribed by the Act, including qualification requirements for the person responsible for sales, quality-control requirements and traceability requirements, such as maintaining sales records, the relevant license may be revoked.」
The risk of license revocation due to failure to meet qualification, quality control and traceability requirements under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices was reiterated. - FY2018First statedAnnual report
「If the Company ceases to meet requirements prescribed by the Act, including qualification requirements for the person responsible for sales, quality-control requirements and traceability requirements, such as maintaining sales records, the relevant license may be revoked.」
The company identified the risk of license revocation if qualification, quality control and traceability requirements under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices are not met. The disclosure also states retention periods of 3 years, or 15 years for specially designated medical devices requiring maintenance.