Oneness Biotech Co., Ltd., Nanchou Plant had been granted with Medical Devices Quality Management System (QMS) Approval.

Published Date:2023-03-15

Statement
No	1	Date of announcement	2023/03/15	Time of announcement	17:52:52
Subject	Oneness Biotech Co., Ltd., Nanchou Plant had been granted with Medical Devices Quality Management System (QMS) Approval.
To which item it meets	paragraph 53			Date of events	2023/03/15
Date of occurrence of the event:2023/03/15 Company name:ONENESS BIOTECH CO., LTD. Relationship to the Company (please enter ”head office” or ”subsidiaries”):head office Reciprocal shareholding ratios:NA Cause of occurrence:The official approval issued by the Taiwan Food and Drug Administration (TFDA) for Medical Device Quality Management System Regulations (QMS) as the manufacturing license had been received today. Approval license number is QMS2138. Countermeasures:None Any other matters that need to be specified(the information disclosure also meets the requirements of Article 7, subparagraph 9 of the Securities and Exchange Act Enforcement Rules, which brings forth a significant impact on shareholders rights or the price of the securities on public companies.): (1)Medical device manufacturers located in Taiwan shall be approved with manufacturing license in compliance with Medical Device Quality Management System Regulations (QMS) prior to manufacturing. (2)With the issuance of the QMS approval, application of export permit will be completed.