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