Risk of Delays in Medical Device Regulation and Approval in Various Countries
First written in FY2016. 4 of 7 entries say "Restated". Latest entry: FY2026.
The whole theme swung hardest in 2026: 3 of 7 companies on the "Worse" side.
1 other company's latest entry also says "Mitigated".
- FY2026MitigatedAnnual report
「Our group is progressively obtaining certification for the transition from MDD to MDR, and the process is in its final stage.」
We stated that preparations for MDR transition certification are in their final stage. We continue to disclose the risk that obtaining certification for new products and maintaining certification for existing products will require time and effort even after the transition is complete. - FY2025RestatedAnnual report
「The group complies with the MDD, but is currently taking steps to comply with the new MDR. If the group’s quality system is not deemed compliant with the MDR, or if certification or registration is denied or delayed, this could have a material impact on the group’s results.」
While complying with the MDD, the company continues its efforts to comply with the MDR and discloses the risks of failure to obtain or delays in certification and registration. - FY2021RestatedAnnual report
「The group complies with the MDD, but is currently taking steps to comply with the new MDR.」
The company continues to explain that, while it complies with the MDD, it is taking steps to comply with the MDR. - FY2019MDR transition response explicitly statedAnnual report
「The MDR (Medical Device Regulation), which strengthens the regulatory requirements and increases the requirements compared with the MDD, has been promulgated, and the transition period from the MDD to the MDR is now under way. The group is taking steps to comply with the MDR, but its business activities may be affected depending on further additions or updates to the regulations and on the responses and requirements of the authorities.」
In addition to the existing regulatory risks in each country, the company explicitly states that Europe is transitioning from the MDD to the MDR and that it is taking steps to comply with the MDR. - FY2018RestatedAnnual report
「If approvals, permits or registrations are denied, revoked or delayed in the future, this could have a material impact on the group’s results.」
The company continues to disclose the risks of failure to obtain, revocation of or delays in medical-device approvals, certifications, registrations and permits in Japan, Europe, the United States and China. - FY2017RestatedAnnual report
「If approvals, permits or registrations are denied, revoked or delayed in the future, this could have a material impact on the group’s results.」
The company continues to disclose the risks of changes, strengthening and delays related to medical-device regulations, certifications, registrations and approvals in Japan, Europe, the United States and China. - FY2016First statedAnnual report
「If these laws and regulations are changed or strengthened and enter into force, the group’s business activities may be affected.」
The company identifies changes, strengthening and delays related to medical-device regulations, certifications, registrations and approvals in Japan, Europe, the United States and China as risks. It states that there have been no past instances in which approval or similar authorization was denied or revoked.