Obtaining Overseas Certifications and Expanding into the US and European Markets
First written in FY2016. 7 of 9 entries say "Advanced", first in FY2017. Latest entry: FY2026.
The whole theme swung hardest in 2022: 1 of 6 companies on the "Worse" side.
6 other companies' latest entry also says "Advanced".
- FY2026AdvancedAnnual report
「Expansion into overseas markets for hemodialysis products is under way, and sales of Supercath NEO began in China. In addition, regulatory applications for Supercath C-Pro and Supercath ProFlex are currently being filed with the Chinese regulatory authorities. In Europe, MDR registration procedures for the ProFlex product are under way under the trade name Supercath ProAdvance.」
In addition to the start of Supercath NEO sales in China, regulatory applications for China and European MDR registration procedures are under way, indicating progress in overseas certification and sales. - FY2025AdvancedAnnual report
「Registration procedures for Supercath NEO, for which a registration application was filed with China's regulatory authority, the NMPA, in the previous fiscal year to expand into overseas markets for dialysis indwelling needles, were completed in the current fiscal year.」
The filing states that Supercath NEO completed NMPA registration in China, validation began in preparation for a US FDA application for Supercath 7, and validation began for coated sheaths intended for the US and European markets. - FY2023AdvancedAnnual report
「In the current fiscal year, applications have been filed with regulatory authorities to ensure that dialysis indwelling needles centered on Supercath Clampcath, Supercath NEO and Supercath Pro comply with the European Medical Device Regulation (MDR), and responses to inquiries from the authorities are under way. In addition, a regulatory application for Supercath NEO is being prepared for expansion into China, with clinical trials currently under way. … An MDR-compliant version of Mongoose, a pediatric angiography catheter, has been sold since June 2022.」
European MDR compliance has progressed from the validation stage to regulatory applications and responses to inquiries. For Supercath NEO for China, the filing states that a regulatory application and clinical trials are under way. The MDR-compliant version of Mongoose began sales in June 2022. - FY2022RestatedAnnual report
「In the current fiscal year, validation work to ensure that dialysis indwelling needles, centered on Supercath NEO, comply with the European Medical Device Regulation (MDR) has continued in order to expand into overseas markets, including Europe. … Validation work to ensure compliance with the European Medical Device Regulation (MDR) has continued in order to expand distribution channels in the European market.」
Validation work for compliance with the European MDR is continuing, but this filing does not cite any new completion milestone, such as completion of certification. - FY2021AdvancedAnnual report
「As part of further expansion into overseas markets, preparations have begun to ensure that Supercath NEO and Supercath C-Pro comply with Europe's Medical Device Regulation (MDR).」
Preparations for Supercath NEO and Supercath C-Pro to comply with the MDR have advanced in preparation for expansion into Europe. Preparations for Supercath 5 to comply with the European MDR are also under way. - FY2020AdvancedAnnual report
「As part of its overseas expansion, the company began exporting Supercath NEO to Australia and continued expanding exports to the European market. It also began exporting Happycass C-Pro to Taiwan.」
Exports of Supercath NEO to Australia and Happycas C-Pro to Taiwan have begun, and overseas distribution channels, including Europe, are being expanded. - FY2018AdvancedAnnual report
「For Happycass NEO, the company completed an agreement with a European representative, made a CE Mark declaration in fiscal 2017 under the name Supercath NEO, and began full-scale overseas expansion into Europe. For Supercath 5, the company changed the product to a type with improved safety-mechanism performance. In fiscal 2017, it also expanded Supercath 5's overseas operations into North American, South American, European, Asian, and Oceanian markets, filed a 510(k) application with the US FDA for the 26G product lineup in August 2017, and obtained clearance on 23 March 2018.」
The disclosure describes the CE Mark declaration and start of sales in Europe for Supercath NEO, the expansion of Supercath 5's target regions, and US FDA 510(k) clearance for the 26G products. - FY2017AdvancedAnnual report
「The company has further expanded Supercath 5's overseas operations into North American, South American, European, Asian, and Oceanian markets. In addition, it obtained US FDA 510(k) clearance for Supercath 6, which adds a mechanism for sliding the outer needle to Supercath 5, already sold in Japan.」
Supercath 5's target regions were expanded to North America, South America, Europe, Asia, and Oceania, and US FDA 510(k) clearance was obtained for Supercath 6. - FY2016First statedAnnual report
「For Happycass NEO, the company is proceeding with work toward obtaining the CE Mark with a view to expanding overseas into Europe. For Supercath 5, the company has begun shipments to the US and European markets and is expanding its overseas operations.」
The disclosure states that work toward obtaining the CE Mark and the start of shipments to the US and Europe were undertaken for the respective products.