Uncertainty over medical device approvals in individual countries and regions
First written in FY2016. 10 of 13 entries say "Mitigated", first in FY2018. Latest entry: FY2026.
The whole theme swung hardest in 2026: 3 of 8 companies on the "Worse" side.
3 other companies' latest entry also says "Mitigated".
- FY2026MitigatedAnnual report
「The medical HAL Single-Joint Type underwent conformity assessment under the MDD (European Medical Devices Directive) and obtained medical device certification in the EU.」
The company obtained certification and approval in Japan and under the European MDR for a compact model of medical HAL, while Cyvis M100 also obtained certification in Japan, expanding the products and regions with a track record of approvals and certifications. - FY2024MitigatedAnnual report
「In May 2024, approval was obtained for cerebral palsy, HTLV-1-associated myelopathy (HAM) and hereditary spastic paraplegia, as well as, ahead of the rest of the world, medical device approval for a compact model.」
The company obtained approval in the US for cerebral palsy, HAM, hereditary spastic paraplegia and a compact model, further expanding its medical device approval track record and the scope of indications. It continues to disclose uncertainty over the timing of approvals and other matters in other regions. - FY2023-Q3MitigatedAnnual report
「Following Malaysia, Thailand and Australia, medical device approval was also obtained in Taiwan for the medical HAL® Single-Joint Type.」
Medical device approval was obtained in Taiwan for the medical HAL Single-Joint Type, expanding the regions with a track record of approval. - FY2021-Q3MitigatedAnnual report
「Following Malaysia, Thailand and Indonesia, medical device approvals and certifications were obtained in Taiwan, for spinal cord injury only, Australia, Singapore and Turkey for a broad range of indications, including stroke, spinal cord injury and neuromuscular disorders.」
Approvals and certifications in Taiwan, Australia, Singapore and Turkey further reduced the uncertainty surrounding medical device approvals in individual countries. - FY2021-Q2MitigatedAnnual report
「Following Malaysia, Thailand and Indonesia, medical device approval was obtained in Taiwan, for spinal cord injuries only, and Australia for a broad range of indications, including stroke, spinal cord injuries and neuromuscular intractable diseases. Reviews for medical device approval are also under way in Singapore, Turkey and other countries.」
Approvals in Taiwan and Australia expanded the regions with a track record of medical device approval. Reviews remain ongoing in Singapore, Turkey and other countries. - FY2021-Q1MitigatedAnnual report
「Medical device approvals were obtained in Malaysia in October 2019 and in Thailand and Indonesia in April 2020, covering a broad range of indications, including stroke, spinal cord injury, and neuromuscular disorders, as in the EU. Reviews for medical device approval are also under way in Taiwan, Singapore, Turkey and other markets.」
The company reiterates that medical device approval has been obtained in Malaysia, Thailand and Indonesia, expanding the regions with a track record of approval. Reviews remain ongoing in Taiwan, Singapore, Turkey and other countries. - FY2020MitigatedAnnual report
「Medical device approvals were obtained in Malaysia in October 2019 and in Thailand and Indonesia in April 2020, covering a broad range of indications, including stroke, spinal cord injury, and neuromuscular disorders, as in the EU. Reviews for medical device approval are also under way in Taiwan, Singapore, Turkey and other markets.」
Following Malaysia, medical device approval was obtained in Thailand and Indonesia, further expanding the regions with a track record of approval. Approval procedures remain ongoing in Taiwan, Singapore, Turkey and other countries. - FY2020-Q3MitigatedAnnual report
「The HAL® Single-Joint Type obtained medical device certification from TÜV Rheinland, a third-party certification body, in October 2019. The certification confirms conformity with the European Medical Devices Directive. Following this, preparations are under way to submit applications in the US and Asian countries.」
The Single-Joint Type obtained certification of conformity with the European Medical Devices Directive, and preparations for applications in the US and Asian countries have begun, expanding the product's approval track record. - FY2020-Q2MitigatedAnnual report
「In October 2019, the company obtained approval in Malaysia. Approval review is currently under way in Thailand, and procedures for filing an approval application have also begun in Taiwan.」
Approval in Malaysia expanded the regions where medical device approval has been obtained. Approval procedures remain ongoing in Thailand and Taiwan. - FY2019RestatedAnnual report
「The Group has obtained medical device approval for HAL® in the EU, Japan, the US and other countries, but there is no advance guarantee that HAL® or any other Group product will obtain medical device approval in other countries or regions. Even if approval is obtained, the timing may differ from country to country and from region to region.」
The company continues to disclose its track record of approvals in the EU, Japan, the US and other countries, while noting uncertainty over the possibility and timing of approvals in other regions. - FY2018MitigatedAnnual report
「The Group has obtained medical device approval for HAL® in the EU, Japan, the US and Saudi Arabia, but there is no advance guarantee that HAL® or any other Group product will obtain medical device approval in other countries or regions. Even if approval is obtained, the timing may differ from country to country and from region to region.」
Although the areas with a track record of approval expanded with approvals in the US and Saudi Arabia, the company states that risks concerning the possibility and timing of approvals in other regions remain. - FY2017RestatedAnnual report
「The Group has obtained medical device approval for HAL® in the EU and Japan, but there is no advance guarantee that HAL® or any other Group product will obtain medical device approval in other countries or regions. Even if approval is obtained, the timing may differ from country to country and from region to region.」
The company continues to disclose uncertainty over the possibility and timing of approvals outside the EU and Japan. - FY2016First statedAnnual report
「The Group has obtained medical device approval for HAL® in the EU and Japan, but there is no guarantee that HAL® or any other Group product will obtain medical device approval in other countries or regions. Even if approval is obtained, the timing may differ from country to country and from region to region.」
The company states that HAL has been approved in the EU and Japan, while the possibility and timing of approvals in other regions remain uncertain.