SNQ Quality Mark

SNQ is built on evidence-based standards, setting trusted quality and safety benchmarks for healthcare, biomedical, health, and animal care services and products.

  • 9F, No. 508, Sec. 7, Zhongxiao E. Rd., Nangang Dist., Taipei City, Taiwan
  • +886 2 2655 7888
  • snq@snq.com.tw

About the National Quality Mark

  • Vision & Mission
  • Review Committee
  • Certification Schedule

Certification Methods

  • Medical Service
  • Biomedical Product
  • Health Product
  • Animal Care & Products

SNQ Certified

  • Certified Services & Products
  • Certified Organizations
  • Quality Award Winners

International Certification

  • ICHOM PROMs
  • NSF Certification

Quality Focus

  • Apply for Certification →
Organized by｜Research Center for Biotechnology and Medicine PolicyOperated by｜Kuanglu International Quality Standards Co., Ltd.© 2026 Kuanglu International Quality Standards Co., Ltd. All rights reserved.Privacy Policy
SNQ Quality Mark
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Product Description

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

Approvals

Department of Health Medical Equipment No. 002553 

有效日期：20250401

Manufacturer

Sinwanai International Co.,Ltd 

No. 99-694723-00

QC Implementation

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.

Risk Management System

Risk analysis
  • Identify the efficacy and foreseeable misuse of medical materials.
  • Confirm product safety features.
  • Confirm possible hazards and hazardous situations.
  • Estimate the risk.
Risk control
  • Analysis of control measures.
  • Execution of control measures.
  • Residual risk assessment.
  • Risk and benefit analysis.
  • Will the risk increase after the control?

Post-Market Surveillance

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

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Rehabilitation & Assistive Technology

""Sinwanai"" Motorized Tractor

Organization
Sinwanai International Co., Ltd.
Certification Year
2004、2005、2006、2007、2008、2009、2010、2011、2012、2013、2014、2015、2016、2017、2018、2019、2020、2021、2022、2023、2024、2025
""Sinwanai"" Motorized Tractor
""Sinwanai"" Motorized Tractor