Obtaining and Maintaining Licenses and Registrations in the Clinical Diagnostics Field
First written in FY2016. 4 of 9 entries say "Restated". Latest entry: FY2026.
Precision System Science moved to the "Worse" side of this theme in 2026.
0 other companies' latest entry also says "Reframed".
- FY2026ReframedAnnual report
「The Group's businesses and products are subject to the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices, as well as laws and regulations in each country and region relating to medical devices, in vitro diagnostic medicinal products, imports and exports, the environment, chemical substances and other matters.」
The risk description was broadened from the previous risk of obtaining regulatory approvals to comprehensive legal and regulatory risks, including tighter regulation of medical devices, in vitro diagnostic medicinal products, imports and exports, and the environment, new regulations, and the acquisition or maintenance of approvals, certifications and licenses. - FY2020MitigatedAnnual report
「In Japan, the Company holds a Class 3 medical device marketing authorization, a manufacturing registration, a repair business license and a sales business license. In addition, because it plans to develop a PCR reagent business in the future, it holds a marketing authorization for in vitro diagnostic medicinal products and a manufacturing registration. Diagenode SA (Belgium), which manufactures the reagents, is registered as a foreign manufacturer of in vitro diagnostic medicinal products.」
The disclosure described track records of obtaining the domestic marketing authorization and manufacturing registration for in vitro diagnostic medicinal products required for the PCR reagent business, as well as registration as an overseas manufacturer, in addition to medical device approvals. At the same time, the Company states that there is no guarantee that these approvals and registrations can be maintained. - FY2019MitigatedAnnual report
「In Japan, the Company holds a Class 3 medical device marketing authorization, a manufacturing registration, a repair business license and a sales business license. Overseas, the Group's DNA automatic extraction systems and other products have obtained CE-IVD marking as in vitro diagnostic medical devices in Europe.」
Specific track records of obtaining regulatory approvals and registrations were described, including various approvals and registrations in Japan, CE-IVD marking in Europe and notification of a nucleic acid extraction system in China. At the same time, the Company states that there is no guarantee that these approvals and registrations can be maintained. - FY2018RestatedAnnual report
「The Group plans to enter the clinical testing field by equipping its fully automated system, which covers the process from gene extraction through diagnosis, with various reagents. It will therefore continue preparing to obtain the necessary regulatory approvals, but there is no guarantee that the Group will be able to obtain them.」
While the company has a track record of obtaining some approvals through OEM arrangements, uncertainty remains over obtaining the regulatory approvals required for its proprietary fully automated system. - FY2017RestatedAnnual report
「Our group plans to enter the clinical diagnostics field by incorporating various reagents into an integrated automated system covering the process from gene extraction through diagnosis. We will therefore continue preparing to obtain the necessary approvals and licenses, but there is no guarantee that our group will be able to obtain them.」
While the company has a track record of obtaining approvals for OEM products, the risk remains that it is uncertain whether the necessary regulatory approvals for its proprietary fully automated system can be obtained. - FY2017-Q3RestatedAnnual report
「Our OEM instruments are sold worldwide after obtaining medical-device approvals in the respective countries.」
The explanation was repeated that the OEM equipment is sold after obtaining medical device approvals in various countries. - FY2017-Q2RestatedAnnual report
「Our OEM instruments are sold worldwide after obtaining medical-device approvals in the respective countries.」
The explanation was repeated that the OEM equipment is sold after obtaining medical device approvals in various countries. This does not indicate that new approvals have been obtained. - FY2017-Q1MitigatedAnnual report
「Our OEM instruments are sold worldwide after obtaining medical-device approvals in the respective countries.」
The company stated that specific OEM instruments had obtained medical-device approvals in the respective countries, indicating progress on some approval and licensing risks. However, this does not state that the risks for all products and all regions have been eliminated. - FY2016First statedAnnual report
「Our group plans to enter the clinical diagnostics field by incorporating various reagents into an integrated automated system covering the process from gene extraction through diagnosis. We will therefore continue preparing to obtain the necessary approvals and licenses, but there is no guarantee that our group will be able to obtain them.」
The possibility of failing to obtain the domestic and overseas approvals and licenses required to enter the clinical diagnostics systems business was identified as a risk.