Regulatory Compliance under the Pharmaceutical Affairs Law, QMS Ministerial Ordinance, and Other Regulations
First written in FY2016. 6 of 7 entries say "Restated". Latest entry: FY2024.
The whole theme swung hardest in 2018: 1 of 7 companies on the "Worse" side.
7 other companies' latest entry also says "Restated".
- FY2024RestatedAnnual report
「We hold permits under the Pharmaceutical Affairs Law and QMS Ministerial Ordinance and are supervised by the Ministry of Health, Labour and Welfare and Kanagawa Prefecture (Class 2 medical device marketing business permit No. 14B2X00034, valid from 11 September 2023 to 10 September 2028; medical device manufacturing registration No. 14BZ005014, valid from 11 September 2023 to 10 September 2028; No. 14BZ200319, valid from 5 August 2019 to 4 August 2024; in vitro diagnostic pharmaceutical manufacturing permit No. 14E1X80023, valid from 18 July 2021 to 17 July 2026; No. 14EZ286017, valid from 18 July 2021 to 17 July 2026).」
The business premise of licensing and supervision under the Pharmaceutical Affairs Law and QMS Ministerial Ordinance continues. Updated validity periods for permits and registrations are provided. - FY2023RestatedAnnual report
「We hold permits under the Pharmaceutical Affairs Law and QMS Ministerial Ordinance and are supervised by the Ministry of Health, Labour and Welfare and Kanagawa Prefecture (Class 2 medical device marketing business permit No. 14B2X00034, valid from 11 September 2018 to 10 September 2023; medical device manufacturing registration No. 14BZ000484, valid from 24 February 2022 to 23 February 2027; No. 14BZ005014, valid from 11 September 2018 to 10 September 2023; No. 14BZ200319, valid from 5 August 2019 to 4 August 2024; in vitro diagnostic pharmaceutical manufacturing permit No. 14E1X80023, valid from 18 July 2021 to 17 July 2026; No. 14EZ286017, valid from 18 July 2021 to 17 July 2026).」
The business premise of licensing and supervision under the Pharmaceutical Affairs Law and QMS Ministerial Ordinance continues. Updated permit and registration numbers and validity periods are provided. - FY2022RestatedAnnual report
「We hold permits under the Pharmaceutical Affairs Law and QMS Ministerial Ordinance and are supervised by the Ministry of Health, Labour and Welfare and Kanagawa Prefecture (Class 2 medical device marketing business permit No. 14B2X00034, valid from 11 September 2018 to 10 September 2023; medical device manufacturing permit No. 14BZ000484, valid from 24 February 2022 to 23 February 2027; No. 14BZ005014, valid from 11 September 2018 to 10 September 2023; in vitro diagnostic pharmaceutical manufacturing permit No. 14E1X80023, valid from 18 July 2021 to 17 July 2026; No. 14EZ286017, valid from 18 July 2021 to 17 July 2026; No. 14EZ280108, valid from 18 September 2017 to 17 September 2022).」
The disclosure continues to cover the business premise of licensing and supervision under the Pharmaceutical Affairs Law and QMS Ministerial Ordinance. - FY2019RestatedAnnual report
「We hold permits under the Pharmaceutical Affairs Law and QMS Ministerial Ordinance and are supervised by the Ministry of Health, Labour and Welfare and Kanagawa Prefecture (Class 2 medical device marketing business permit No. 14B2X00034, valid from 11 September 2018 to 10 September 2023; medical device manufacturing permit No. 14BZ000484, valid from 24 February 2017 to 23 February 2022; No. 14BZ005014, valid from 11 September 2018 to 10 September 2023; in vitro diagnostic pharmaceutical manufacturing permit No. 14E1X80023, valid from 18 July 2016 to 17 July 2021; No. 14EZ286017, valid from 18 July 2016 to 17 July 2021; No. 14EZ280108, valid from 18 September 2017 to 17 September 2022).」
The disclosure continues to cover the business premise of licensing and supervision under the Pharmaceutical Affairs Law and QMS Ministerial Ordinance. - FY2018RestatedAnnual report
「The marketing and manufacturing businesses for medical devices and in vitro diagnostic pharmaceuticals are subject to regulation under the Pharmaceutical Affairs Law (10 August 1960, Law No. 145), the Ministerial Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Pharmaceuticals (QMS Ministerial Ordinance: Quality Management System; 17 December 2004, MHLW Ministerial Ordinance No. 169), and various related laws and regulations.」
The business continues to be premised on licensing requirements and quality-control regulations under the Pharmaceutical Affairs Law, QMS Ministerial Ordinance and other rules. - FY2017RestatedAnnual report
「The marketing and manufacturing businesses for medical devices and in vitro diagnostic pharmaceuticals are subject to regulation under the Pharmaceutical Affairs Law, the Ministerial Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Pharmaceuticals (QMS Ministerial Ordinance), and various related laws and regulations.」
The business continues to be premised on licensing requirements and quality-control regulations under the Pharmaceutical Affairs Law, QMS Ministerial Ordinance and other rules. - FY2016First statedAnnual report
「We manufacture and sell various medical devices and products related to in vitro diagnostic pharmaceuticals. The marketing and manufacturing businesses for medical devices and in vitro diagnostic pharmaceuticals are subject to regulation under the Pharmaceutical Affairs Law (10 August 1960, Law No. 145), the Ministerial Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Pharmaceuticals (QMS Ministerial Ordinance: Quality Management System; 17 December 2004, MHLW Ministerial Ordinance No. 169), and various related laws and regulations.」
The business is premised on the regulations and licensing requirements under the Pharmaceutical Affairs Law, QMS Ministerial Ordinance and other rules applicable to products related to medical devices and in vitro diagnostic pharmaceuticals.