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Medical Device Evaluation

The Center has been working closely with the Food and Drug Administration (TFDA), Ministry of Health and Welfare of Taiwan in ensuring that medical devices on the market meet the public’s requirement in safety, effectiveness and quality. As one of the Authorized Auditing Organizations, the Center represents TFDA in the technical review for the registration of Class II IVD devices as well as auditing for medical device GMP. In addition, we assist TFDA in the implementation of medical device regulatory control and global harmonization.

Globally, the Center is the first and only accredited Third Party Reviewer of US FDA 510(k) in Asia for class II medical devices and medical device quality systems. The Center colleagues have been the chair/member in the Asian Harmonization Working Party (AHWP) Technical Committee and AHWP Working Groups and International Medical Device Regulators Forum (IMDRF), contributing towards the international co-operation in harmonization of medical device regulation.

The Center is committed to serve the new medical device R&D team in testing and assessment to comply with regulatory and clinical requirements through the establishment of a "Medical Device Testing and Evaluation Platform", thereby facilitate a smooth passage of product realization from regulatory pathway and design planning (TRL3), safety and effectiveness requirement establishment (TRL4), Device specifications and preliminary assessment (TRL5), pre-clinical testing and simulated assessment (TRL6), clinical investigation and evaluation (TRL7), and eventually product approval (TRL8).

Energy and Environment Metrology

Based on the developed measurement technology, the Center offers professional services to domestic industry in Photovoltaics (PV), LED Lighting, Green Chemical Product, and Certified Reference Materials, etc. and obtains related patents. Continuous efforts are put into innovation and new product development.

Our PV & LED labs, certified laboratories of IECEE (IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and Components) and TAF (Taiwan Accreditation Foundation), have cooperated with UL, TŰV, Intertek, JET to provide full calibration service for overcoming technical obstacles in the global market. We get involved in the establishment of industrial standards and CNS standards to complete metrological traceability, and therefore help to upgrade the green industry development.

Center for Measurement Standards, working with the domestic industry, has successfully developed and promoted several innovations into the international market such as Formaldehyde Detector, Ozone Test Cabinet, Verification System for Breath-alcohol Tester & Analyzer, Liquid Density Certified Reference Materials, LED Simulator, etc.