https://lmspiq.fda.gov.tw/web/MDPIQ/MDPIQ1000Result?licBaseId=B9A42838-5CD4-47C1-83DC-D4EEC818A72F

Department of Health Medical Equipment No. 002553 

有效日期：20250401

Sinwanai International Co.,Ltd 

No. 99-694723-00

In compliance with the requirements of relevant laws and regulations, the company has established its quality system in accordance with the domestic Good Manufacturing Practice Standard (QMS) for medical devices and the quality management system requirements of ISO 13485 (CNS15013) medical devices.

• Identify the efficacy and foreseeable misuse of medical materials.
• Confirm product safety features.
• Confirm possible hazards and hazardous situations.
• Estimate the risk.

• Analysis of control measures.
• Execution of control measures.
• Residual risk assessment.
• Risk and benefit analysis.
• Will the risk increase after the control?

Subject to QMS audit by the Department of Health every three years.