List of Certificates and Registration Documents
Medical Device Manufacturing Registration
In accordance with the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (hereinafter referred to as the PMD Act), we have established the necessary systems for the manufacture of medical devices and are registered as a medical device manufacturer (Registration No.: 08BZ000136).
Class 2 Medical Device Manufacturing and Sales License
In order to manufacture and market Class II medical devices, we have established a manufacturing management system, a quality management system (in accordance with the QMS Ordinance) and post-market safety management standards (in accordance with the GVP Ordinance) in accordance with the PMD Act, and have been granted a Class II Medical Device Manufacturing and Marketing Licence (Licence No.: 08B2X00019).
Certificate of Conformity (Pre-filled syringe with needle)
In relation to the manufacture and sale of pre-filled syringes with needles (Class II regulated medical devices), we have undergone an audit by the certification body SGS Japan Inc. to verify compliance with the ‘Standards for the Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Medical Devices (QMS Ordinance)’ under the Pharmaceutical and Medical Devices Act, and have been issued with a Certificate of Conformity (Certification No.: 08BZ000136).
ISO13485:2016
We have obtained certification to ISO 13485:2016, the international standard for quality management systems for medical devices, which is equivalent to the QMS Ministerial Ordinance, following an audit conducted by the certification body SGS Japan Co., Ltd.
In accordance with this standard, we have established a rigorous manufacturing and quality control system and are committed to continuous improvement.