Manufacturing and Marketing Regulations under the Act on Pharmaceuticals and Medical Devices
First written in FY2016. 1 of 3 entries say "Restated". Latest entry: FY2020.
Nihon Trim moved to the "Worse" side of this theme in 2020.
The whole theme swung hardest in 2018: 1 of 7 companies on the "Worse" side.
1 other company's latest entry also says "Reframed".
- FY2020ReframedAnnual report
「The domestic ionizer-related business is subject to the Pharmaceuticals and Medical Devices Act. In the cord blood banking business, a permit to manufacture specified processed cellular products is required to process cord blood under the Act on Securing Safety of Regenerative Medicine. In Japan, the Group's other businesses are also subject to laws and regulations, including the Antimonopoly Act and the Act on the Protection of Personal Information.」
The description has been reorganized from a focus on medical-device regulations to cover a broad range of legal and regulatory requirements, including regenerative medicine, antitrust, personal information protection and regulations in other countries. - FY2017RestatedAnnual report
「The manufacture and sale of our products, which are medical devices, are subject to regulation under the Pharmaceuticals and Medical Devices Act.」
The company has reiterated the risk that the manufacture and sale of medical devices are subject to regulation under the Pharmaceuticals and Medical Devices Act. - FY2016First statedAnnual report
「The manufacture and sale of our products, which are medical devices, are subject to regulation under the Pharmaceuticals and Medical Devices Act.」
The company identifies as risks regulations concerning marketing authorization for medical devices, manufacturing and sales facilities, responsible technical personnel, advertising and other matters.